Machinery Directive 2006/42/EC

1: Introduction to EU Machinery Compliance

Machinery compliance in the European Union is often reduced to a simple question:

“Does this machine need CE marking?”

In practice, the answer is considerably more complex.

Before CE marking can be applied, a manufacturer must determine which EU legislation applies, identify the relevant health and safety requirements, assess the risks created by the machinery, implement appropriate protective measures and compile the required technical documentation.

For many years, the central legal framework for machinery in the EU has been Directive 2006/42/EC – the Machinery Directive.

However, this framework is now changing.

Regulation (EU) 2023/1230 on machinery replaces the Machinery Directive and will become mandatory from 20 January 2027. The Regulation has already entered into force, although most of its substantive requirements apply from that date.

This means that manufacturers currently face a transition between two closely related but legally distinct frameworks.

1.1 The Machinery Directive and the Machinery Regulation

The Machinery Directive 2006/42/EC has provided the principal EU framework for machinery safety for many years.

It establishes essential health and safety requirements and supports the free movement of compliant machinery within the European Single Market. Harmonised standards provide an important means of demonstrating conformity with those requirements.

The new Machinery Regulation (EU) 2023/1230 retains many of these fundamental principles but modernises the framework.

Among other things, it addresses:

• safety-related software;
• AI-powered safety functions;
• cybersecurity;
• digital instructions;
• digital declarations of conformity;
• substantial modifications;
• and updated conformity assessment requirements for certain higher-risk machinery.

The Regulation is also a directly applicable EU legal act, rather than a directive that must first be transposed into national law.

1.2 When Does Each Framework Apply?

This transition is important for manufacturers.

Until 19 January 2027, the Machinery Directive remains the main legal framework for machinery placed on the EU market, subject to the applicable transitional provisions.

From 20 January 2027, the Machinery Regulation becomes mandatory and replaces the Machinery Directive.

The European Commission currently states that machinery placed on the EU market before 20 January 2027 must comply with the Machinery Directive. Manufacturers may, where applicable, also declare conformity with the new Machinery Regulation.

This transition is particularly important for products that are currently being developed but will only be placed on the EU market after January 2027.

1.3 Why This Guide Covers Both

This guide is therefore not simply a guide to an obsolete Directive.

It explains the fundamental principles of EU machinery compliance while also showing how those principles transition into the new Machinery Regulation.

The objective is to answer three practical questions:

1. What requirements apply to machinery today?
2. What changes with Regulation (EU) 2023/1230?
3. What should manufacturers do now to prepare for the transition?

This approach is particularly relevant because many machinery projects have development cycles that extend across the 20 January 2027 transition date.

1.4 What Does Machinery Compliance Actually Involve?

Machinery compliance is a process rather than a single test.

A typical compliance project involves:

Product definition → Scope determination → Applicable legislation → Risk assessment → Essential requirements → Standards → Protective measures → Verification → Technical documentation → Conformity assessment → Declaration of Conformity → CE marking

The exact process depends on the machinery, its intended use, its risks and the applicable conformity assessment procedure.

There is therefore no universal “CE test” that can be performed on every machine.

1.5 Why Correct Scoping Matters

One of the most important steps is determining exactly what the product is from a regulatory perspective.

The Machinery Regulation covers machinery as well as several related products, including:

• interchangeable equipment;
• safety components;
• lifting accessories;
• chains, ropes and webbing;
• removable mechanical transmission devices;
• and partly completed machinery.

Other EU legislation may also apply to the same product.

For example, a machine containing electrical equipment, radio functionality, pressure equipment or other regulated technologies may need to satisfy additional legislation alongside the machinery requirements.

The correct regulatory scope must therefore be established before the detailed conformity assessment begins.

1.6 Risk Assessment Is at the Centre

The fundamental principle remains unchanged:

Machinery compliance starts with understanding the risks created by the machine.

The manufacturer must identify relevant hazards, evaluate the associated risks and determine appropriate measures to eliminate or reduce those risks.

This includes considering not only normal operation, but also foreseeable situations such as:

• installation;
• commissioning;
• maintenance;
• cleaning;
• adjustment;
• foreseeable misuse;
• malfunction;
• and foreseeable abnormal operating conditions.

The resulting risk assessment forms the foundation for many of the subsequent compliance decisions.

1.7 Standards Are Tools, Not the Starting Point

Manufacturers often begin a project by asking:

“Which standards do we need to test against?”

A better approach is:

“What are the characteristics and risks of this machine, and which requirements apply?”

The relevant standards can then be identified based on that assessment.

Harmonised standards can provide an important route to demonstrating conformity, but their selection should follow the understanding of the product and its risks rather than replace it.

1.8 The Increasing Importance of Software and Connectivity

Modern machinery is increasingly different from the machinery for which the original legal framework was developed.

Machines may now include:

• network connections;
• remote access;
• software updates;
• autonomous functions;
• AI-based functions;
• cloud-connected services;
• safety-related software.

The new Machinery Regulation explicitly addresses several of these developments, including AI-powered safety functions and cyber-safety for compliance-relevant software and safety control systems.

This means that machinery compliance is increasingly becoming a combination of mechanical, electrical, functional-safety and digital compliance.

1.9 What This Guide Covers

The following chapters build the compliance process step by step.

They cover:

• determining whether a product is machinery;
• identifying the applicable legislation;
• understanding essential health and safety requirements;
• performing the risk assessment;
• selecting and applying standards;
• electrical and control-system considerations;
• technical documentation;
• conformity assessment;
• CE marking;
• machinery assemblies;
• partly completed machinery;
• modifications;
• market surveillance;
• practical machinery examples;
• and the transition from Directive 2006/42/EC to Regulation (EU) 2023/1230.

The goal is not simply to explain how to obtain CE marking, but to explain how to build a defensible and efficient machinery compliance process.

1.10 The Central Principle

The most important principle for the entire guide is:

CE marking is the result of machinery compliance — not the compliance process itself.

A robust assessment begins with the product, its intended use and its risks.

Only then should the manufacturer determine the applicable requirements, technical solutions, standards, evidence and conformity assessment procedure.

And because the legal framework is now changing, manufacturers must consider not only what is required today, but also which legal framework will apply when the machinery is actually placed on the EU market.

That transition is an important theme throughout this guide.

2. Legal Framework of the Machinery Directive

To apply the Machinery Directive correctly, it is not enough to know individual requirements from Annex I or to compile a list of standards. The first step is to understand how the Directive is structured, what function its different provisions have, and how it interacts with other European and national legislation.

Directive 2006/42/EC on machinery is a European Union legal act forming part of the EU internal market framework. It was adopted on 17 May 2006 as a recast of the previous Machinery Directive 98/37/EC. The consolidated version currently available on EUR-Lex incorporates amendments applicable through 30 May 2026. EUR-Lex – Directive 2006/42/EC

For manufacturers, it is particularly important to distinguish between three levels:

1. the European legal act itself, i.e. the Machinery Directive;
2. national implementation and enforcement in the Member States; and
3. technical standards and other technical specifications, which may play an important role in implementing and demonstrating compliance.

These three levels are closely connected, but they are not the same thing.

2.1 Structure and Systematics of the Directive

The Machinery Directive is not simply a list of technical safety requirements. It is systematically structured and contains different types of provisions.

The most important elements include:

• the recitals;
• the articles of the Directive;
• the annexes;
• definitions;
• requirements for placing machinery on the market and putting it into service;
• conformity assessment provisions;
• CE marking requirements;
• provisions concerning market surveillance; and
• provisions concerning partly completed machinery.

For practical manufacturer work, Articles 1 to 29 and Annexes I to XI are particularly relevant.

The articles establish the legal framework, while the annexes provide more detailed requirements and procedures.

A typical example is Article 5. It sets out the obligations that the manufacturer or authorised representative must fulfil before machinery is placed on the market or put into service. These include ensuring compliance with the applicable essential health and safety requirements, making the technical file available, providing the necessary information, carrying out the appropriate conformity assessment procedure, drawing up the EC Declaration of Conformity and affixing the CE marking. EUR-Lex – Machinery Directive 2006/42/EC

The annexes provide the corresponding details.

Particularly important are:

• Annex I – Essential health and safety requirements;
• Annex II – Declarations;
• Annex III – CE marking;
• Annex IV – Categories of machinery for which particular conformity assessment procedures may be relevant;
• Annex V – Non-exhaustive list of safety components;
• Annex VI – Assembly instructions for partly completed machinery;
• Annex VII – Technical file;
• Annex VIII – Assessment of conformity with internal checks on the manufacture of machinery;
• Annex IX – EC type-examination;
• Annex X – Full quality assurance; and
• Annex XI – Minimum criteria to be taken into account for the notification of bodies.

The Directive should therefore not be read in isolation, article by article.

A manufacturer often needs to connect several provisions.

For example, the question:

“What documentation do I need for my machine?”

cannot necessarily be answered by referring to a single article.

Articles 5, 12 and 13, together with Annexes II and VII, may all be relevant.

2.2 Articles and Annexes – How Should the Directive Be Read?

One of the most common difficulties when applying the Machinery Directive is that manufacturers sometimes read individual provisions without considering their relationship with the rest of the Directive.

A better approach is to use a systematic reading sequence.

Step 1: Determine the Scope

First determine whether the product falls within the scope of the Directive.

Article 1 defines the product categories covered by the Directive and also identifies products that are explicitly excluded. EUR-Lex – Machinery Directive, Article 1

Step 2: Check the Definitions

The definitions in Article 2 must then be examined.

This is particularly important because the Directive gives specific legal meanings to certain terms. The definition of “machinery”, for example, is broader and more specific than the ordinary everyday meaning of the word. It covers several different configurations, including machinery equipped with or intended to be equipped with a drive system, certain assemblies and assemblies of machinery that function together as an integrated whole. EUR-Lex – Machinery Directive

Step 3: Check Other Legislation

It must then be determined whether other European legislation applies more specifically to certain hazards or product aspects.

Article 3 establishes an important principle: where hazards covered by Annex I are wholly or partly more specifically addressed by other EU directives, the Machinery Directive does not apply, or ceases to apply, to those hazards once the other directives become applicable. EUR-Lex – Machinery Directive, Article 3

This does not automatically mean that the Machinery Directive becomes completely irrelevant whenever another piece of legislation applies.

Instead, the manufacturer must determine which legal instrument applies to each relevant aspect or hazard.

Step 4: Determine the Essential Requirements

Only then should the applicable essential health and safety requirements in Annex I be systematically identified.

Step 5: Determine the Conformity Assessment Procedure

The appropriate conformity assessment procedure must then be established.

Step 6: Documentation and CE Marking

Finally, the required declarations, documentation and CE marking are completed.

This approach is fundamentally different from:

Select a standard → test the machine → put on the CE mark.

The Machinery Directive instead requires a systematic conformity process.

2.3 Application Date and Transitional Considerations

The Machinery Directive was adopted in 2006, but its practical application did not begin immediately after publication.

Member States first had to transpose the Directive into national law. The original transposition deadline was 29 June 2008. The national provisions implementing the new Machinery Directive then became applicable from 29 December 2009.

Since that date, Directive 2006/42/EC has formed the central European legal framework for machinery and related products within its scope.

Today, however, the historical application date is not the only important consideration. The regulatory framework is changing again.

The Machinery Directive will be replaced by Regulation (EU) 2023/1230 on machinery.

For manufacturers, this is particularly important because machinery projects often have development, production and market lifecycles spanning several years.

A machine whose development starts today may therefore be placed on the market during the transition period or after the new Machinery Regulation becomes applicable.

The relevant question is consequently not only:

“What requirements apply today?”

but also:

“When will this particular product be placed on the market or put into service, and which legal framework applies at that point?”

For long-term machinery projects, this timing can be highly significant.

The transition from the Machinery Directive to the Machinery Regulation will therefore be covered separately and in detail later in this guide.

2.4 National Implementation of the Directive

One of the fundamental legal differences between a directive and a regulation is that a directive must be transposed into national law by the Member States.

The Machinery Directive therefore requires Member States to adopt the necessary national laws, regulations and administrative provisions.

For manufacturers, this means:

The Machinery Directive provides the European framework, while enforcement takes place within national legal systems.

This is particularly relevant for:

• competent authorities;
• market surveillance;
• national administrative procedures;
• sanctions;
• national requirements outside harmonised product legislation; and
• certain occupational health and safety requirements.

These areas must not be confused.

Product Safety and Occupational Safety Are Not the Same

For example, a manufacturer must comply with the Machinery Directive when placing a machine on the European market.

The operator of that machine may additionally have obligations under national occupational health and safety legislation.

This creates two different perspectives:

Manufacturer perspective

Is the machine compliant as a product?

Operator perspective

Is the machine operated safely in the workplace?

These questions overlap in some areas, but they are not legally identical.

The Machinery Directive focuses on machinery as a product and on the corresponding obligations of the relevant economic operators.

2.5 Relationship with Other EU Legislation

Machinery is frequently subject to more than one European legal act.

A modern machine may contain:

• electrical components;
• electronic control systems;
• radio modules;
• pressure systems;
• drives;
• software;
• safety-related control systems; or
• lasers or other sources of radiation.

This can result in additional European legislation becoming relevant.

The Machinery Directive therefore contains an important relationship rule in Article 3. Where certain hazards are more specifically regulated by another EU directive, that specific legislation applies to those hazards. EUR-Lex – Machinery Directive, Article 3

In addition, Article 5(4) provides that where machinery is subject to other EU legislation concerning CE marking, the CE marking also indicates conformity with those other applicable provisions. The relevant legislation applied must be identified in the EC Declaration of Conformity. EUR-Lex – Machinery Directive, Article 5

This leads to an important principle:

A machine can be subject to several pieces of European legislation at the same time.

The manufacturer’s task is therefore not simply to “apply the Machinery Directive”. The first task is to determine the complete regulatory scope of the product.

This topic will be examined in detail in Chapter 5.

2.6 Relationship with National Requirements

In addition to harmonised European product legislation, Member States have numerous national requirements.

These must be carefully distinguished.

National Product Requirements

Where an area is fully harmonised by EU product legislation, Member States generally cannot simply impose additional national product requirements that conflict with the harmonised framework.

Article 6 of the Machinery Directive establishes the principle of free movement. Member States may not prohibit, restrict or impede the placing on the market or putting into service of machinery that complies with the Directive. EUR-Lex – Machinery Directive, Article 6

National Requirements for Operators

This must be distinguished from requirements governing the safe operation of machinery in the workplace.

A manufacturer may therefore supply a compliant machine while the operator remains subject to national requirements concerning, for example:

• installation;
• workplace design;
• employee training;
• inspections;
• maintenance;
• periodic checks; or
• operational safety.

These requirements do not automatically form part of the manufacturer’s product conformity assessment under the Machinery Directive.

Practical Consequence

A compliance assessment should therefore clearly document:

Which requirements apply to the product?

and

Which requirements apply to its subsequent operation?

This distinction helps prevent manufacturers from assuming obligations that belong to the operator — or overlooking requirements that must already be addressed at the product stage.

2.7 Role of the European Commission

The European Commission plays an important role in the development, coordination and practical support of European machinery legislation.

The Commission publishes, among other things:

• information on the Machinery Directive;
• information on the Machinery Regulation;
• application guides;
• information on harmonised standards;
• information on market surveillance; and
• information on regulatory developments.

Of particular importance to manufacturers is the Guide to Application of the Machinery Directive 2006/42/EC.

The European Commission provides this Guide as a practical aid to the application of the Machinery Directive. The current Edition 2.3 was published in April 2024 and contains explanations and examples covering essentially the entire scope of the Directive. European Commission – Machinery

The Guide is nevertheless not the Machinery Directive itself.

This distinction is legally important.

The Directive is the binding legal act.

The Guide supports the interpretation and practical application of the Directive.

For this ScopeRight guide, this means that we will distinguish carefully between:

“The Directive requires …”

and

“The European Commission’s Guide explains …”

rather than presenting an interpretation contained in the Guide as though it were statutory wording.

2.8 Role of Market Surveillance Authorities

Compliance does not automatically end when the CE marking is affixed.

Member States are responsible for ensuring that the Machinery Directive is effectively enforced within their territories.

Article 4 requires Member States to take appropriate measures for market surveillance. Machinery may generally only be placed on the market or put into service when it complies with the relevant requirements and, when properly installed and maintained and used for its intended purpose or under reasonably foreseeable conditions, does not endanger the health or safety of persons. Member States must also designate or establish competent authorities responsible for monitoring conformity. EUR-Lex – Machinery Directive, Article 4

This creates an important relationship:

Manufacturer

→ designs and manufactures the machine

→ prepares the technical documentation

→ performs the conformity assessment

→ draws up the Declaration of Conformity

→ affixes the CE marking

Market surveillance

→ monitors products on the market

→ may request documentation and evidence

→ may arrange technical examinations

→ may require corrective action in cases of non-compliance

The European Commission identifies market surveillance as an important mechanism for ensuring the effective application of EU product legislation and keeping unsafe products off the market. European Commission – Machinery

What Does This Mean for Manufacturers?

A manufacturer should therefore not prepare its technical documentation merely with the question:

“What do we need in order to put the CE mark on the machine?”

A better question is:

“Could we demonstrate and defend the conformity of this machine if a competent authority asked us to provide the evidence?”

That is an important difference.

The technical documentation is not merely an internal project archive. It provides evidence of how the manufacturer arrived at its conformity decision.

2.9 The Legal Framework in Practice

For a manufacturer, the legal framework of the Machinery Directive can be represented as a sequence:

1. European legislation

Which EU legal acts apply to the product?

↓

2. Scope

Does the product fall within the Machinery Directive?

↓

3. Definitions and classification

How is the product legally classified?

↓

4. Specific legislation

Are other EU legal acts more specific for particular hazards or product aspects?

↓

5. Essential requirements

Which essential health and safety requirements of Annex I apply?

↓

6. Risk assessment

What hazards arise from the machine and how are they reduced?

↓

7. Technical implementation

Which design and technical measures are required?

↓

8. Standards

Which harmonised standards or other technical specifications can support implementation and demonstration of conformity?

↓

9. Conformity assessment

Which procedure is required?

↓

10. Documentation

Which evidence and declarations must be prepared?

↓

11. CE marking

Can the CE marking legally be affixed?

↓

12. Market surveillance

Can conformity still be demonstrated if the authorities investigate the product after it has been placed on the market?

This sequence is a much more useful model for practical compliance work than a simple list of standards.

2.10 An Important Principle: CE Marking Comes at the End

The structure of the Machinery Directive makes clear why CE marking should not be treated as the starting point of a conformity assessment.

Article 5 establishes the manufacturer’s obligations before machinery is placed on the market or put into service. These include compliance with the applicable essential health and safety requirements, preparation of the technical file, provision of the necessary information, completion of the appropriate conformity assessment procedure, preparation of the EC Declaration of Conformity and, subsequently, affixing the CE marking. EUR-Lex – Machinery Directive, Article 5

In practical terms:

CE is the result of a conformity process — not a substitute for one.

A CE mark on a machine therefore does not, by itself, demonstrate that the machine is actually compliant.

The underlying technical and legal assessment is what makes the CE marking meaningful.

2.11 Why the Regulatory Scope Must Come Before the Technical Scope

A common mistake in machinery projects is to begin immediately with technical questions:

• Which standard do we need?
• Which tests are required?
• Which laboratory can perform them?
• Which safety components do we need?
• What Performance Level is required?

These questions can all be important.

But they are not necessarily the first questions.

The first question should be:

Which legal requirements actually apply to this product?

Only after this has been established can the relevant technical requirements be determined properly.

This approach is consistent with the structure of the Machinery Directive itself.

Article 5 requires manufacturers to ensure compliance with the applicable essential health and safety requirements and to prepare the technical documentation, provide the required information and carry out the appropriate conformity assessment procedure. EUR-Lex – Machinery Directive, Article 5

A professional compliance process should therefore begin with a regulatory scope assessment.

Only then should the detailed technical scope be developed.

2.12 What Manufacturers Should Take Away from the Legal Framework

The structure of the Machinery Directive leads to several fundamental practical rules.

Rule 1: Determine the scope first

Not every product with moving parts automatically falls under the Machinery Directive, and not every product described as a “machine” in everyday language has the same legal classification.

Rule 2: Take the definitions seriously

The terms defined in Article 2 have specific legal meanings.

Rule 3: Check other EU legislation

A machine may be subject to several European legal acts. Articles 3 and 5 must therefore be considered together with other applicable legislation. EUR-Lex – Machinery Directive

Rule 4: Do not confuse national requirements with EU product legislation

Manufacturer obligations and operator obligations may arise from different legal frameworks.

Rule 5: Use the official Guide as an application and interpretation aid

The European Commission’s Guide is an important practical source, but it does not replace the legal act itself. European Commission – Machinery

Rule 6: Consider market surveillance

Technical documentation should not merely be understandable to the internal project team. It should make the conformity decision traceable and defensible.

Rule 7: Do not confuse CE marking with certification

CE marking is part of the European conformity framework. It is not a general voluntary quality certification.

Summary

The Machinery Directive is a systematically structured European legal framework.

For practical application, manufacturers need to connect at least five levels:

1. Scope and definitions
2. Applicable European legislation
3. Essential health and safety requirements
4. Conformity assessment and technical evidence
5. CE marking and market surveillance

The sequence is particularly important.

A professional compliance process does not begin with a standard and does not end with a CE sticker.

It begins with the question:

What exactly is our product, and which legal requirements apply to it?

Only after that question has been answered can the risk assessment, standards selection, testing, technical documentation and conformity assessment be structured properly.

The next chapter therefore addresses the fundamental question that should stand at the beginning of every machinery project:

Which products actually fall within the scope of the Machinery Directive?

This is considerably more complex than it may initially appear, because Articles 1 and 2 contain several product categories, definitions and exclusions that can lead to incorrect classification in practice.

Official Sources

• European Union, Directive 2006/42/EC on machinery, consolidated version applicable as of 30 May 2026. EUR-Lex – Machinery Directive 2006/42/EC
• European Commission, Machinery – Internal Market, Industry, Entrepreneurship and SMEs. European Commission – Machinery
• European Commission, Guide to Application of the Machinery Directive 2006/42/EC, Edition 2.3, April 2024. European Commission – Machinery

3. Which Products Fall Within the Scope of the Machinery Directive?

One of the most important — and at the same time most frequently misunderstood — questions in machinery compliance is:

Does this product actually fall within the scope of the Machinery Directive 2006/42/EC?

The answer is not always obvious.

A product may look like a machine from a technical or commercial perspective without necessarily being classified in the same way under the Directive. Conversely, products that are not normally described as “machines” can explicitly fall within its scope.

The starting point is Article 1 of the Machinery Directive. It defines the product categories covered by the Directive and, at the same time, lists a number of exclusions. Article 2 then provides the legal definitions needed to classify those products correctly.

For a manufacturer, this makes scope determination one of the first and most important compliance activities.

A wrong classification at this stage can affect everything that follows:

• the applicable EU legislation;
• the applicable essential health and safety requirements;
• the risk assessment;
• the standards selected;
• the conformity assessment procedure;
• the technical documentation;
• the Declaration of Conformity;
• and ultimately the CE marking.

The correct approach is therefore not:

“It has moving parts, so it must be a machine.”

Instead, the manufacturer should work through the legal definitions and exclusions systematically.

3.1 The Seven Product Categories Covered by Article 1

Article 1(1) of the Machinery Directive identifies seven product categories:

1. Machinery
2. Interchangeable equipment
3. Safety components
4. Lifting accessories
5. Chains, ropes and webbing
6. Removable mechanical transmission devices
7. Partly completed machinery

This is an important starting point because the term “machinery” in the everyday sense is narrower than the scope of the Directive.

A manufacturer may therefore have a product covered by the Machinery Directive even though it is not itself a complete machine.

The following sections examine these categories individually.

3.2 Machinery

The central category is, of course, machinery.

Article 2(a) defines “machinery” in a specific legal manner. The definition includes several different situations rather than one simple physical configuration.

The first and most familiar case is an assembly:

• consisting of linked parts or components;
• with at least one moving part;
• joined together for a specific application; and
• fitted or intended to be fitted with a drive system other than directly applied human or animal effort.

This definition is important because several conditions must be considered together.

Moving parts

At least one part of the assembly must move.

However, the mere presence of movement is not sufficient on its own to classify a product as machinery.

The other elements of the definition must also be considered.

A drive system

The machinery must be fitted with, or intended to be fitted with, a drive system other than directly applied human or animal effort.

This can include different forms of energy and drive technology.

The legal definition therefore does not simply mean:

“A machine with an electric motor.”

Hydraulic, pneumatic and other drive systems can also be relevant.

A specific application

The components must be joined together for a specific application.

This is another important part of the definition. The assessment is therefore not based solely on the physical construction of a product.

Its intended function and application are relevant to its legal classification.

3.3 Machinery That Is Not Yet Fully Complete

The definition of machinery also covers certain products that are not yet ready for independent operation.

For example, Article 2(a) includes an assembly that is missing only the components necessary to connect it at the place of use or to sources of energy and motion.

It also covers an assembly that is ready to be installed but can only function once it has been mounted on a means of transport or installed in a building or structure.

This is an important distinction.

A manufacturer cannot necessarily avoid the Machinery Directive simply by supplying a machine without its final installation connections.

The legal classification depends on what is missing and what the product is intended to be when supplied.

This is one reason why the distinction between:

• complete machinery,
• machinery requiring installation,
• and partly completed machinery

must be carefully examined.

3.4 Assemblies of Machinery

The Machinery Directive also covers certain assemblies of machinery.

Article 2(a) includes assemblies of machinery, or partly completed machinery, which are arranged and controlled so that they function as an integral whole in order to achieve a common result.

This is particularly important for industrial production systems.

Consider a production line consisting of:

• a loading machine;
• a conveyor;
• a processing machine;
• a robotic handling system; and
• a packaging machine.

Each individual machine may already have its own conformity assessment.

That does not automatically mean that the complete installation can simply be treated as a collection of unrelated CE-marked machines.

If the individual units are arranged and controlled so that they function together as an integrated whole to achieve a common result, the overall assembly may itself fall within the definition of machinery.

This is one of the most important practical scope issues for system integrators.

CE marking one machine does not automatically make an entire production line compliant

A common misconception is:

“Every machine in the line has a CE mark, therefore the line is compliant.”

That conclusion can be incorrect.

The interaction between the machines can create additional hazards.

For example:

• a conveyor may start automatically when another machine enters a particular state;
• one machine may cause another machine to move;
• emergency-stop functions may need to operate across several machines;
• access to one machine may expose a person to hazards from another;
• safety-related control functions may depend on signals exchanged between different machines.

The integration of the individual machines can therefore create safety considerations that do not exist when each machine is considered independently.

The legal and technical assessment of assemblies of machinery is consequently a major topic in its own right.

3.5 Interchangeable Equipment

The second product category listed in Article 1 is interchangeable equipment.

Article 2(b) defines interchangeable equipment as a device that, after machinery or a tractor has been put into service, is assembled with that machinery or tractor by the operator in order to change its function or attribute a new function, provided that the equipment is not a tool.

This definition has several important elements.

The equipment must:

1. be assembled with machinery or a tractor;
2. be assembled after that machinery or tractor has been put into service;
3. be assembled by the operator;
4. change the function of the machinery or provide a new function; and
5. not simply be a tool.

This means interchangeable equipment is not simply another name for an accessory.

Its purpose is to change or add to the function of the machine.

Examples can include equipment attached to a base machine to enable it to perform a different operation.

The manufacturer of interchangeable equipment therefore needs to consider the equipment itself as a regulated product.

3.6 Safety Components

The third category is safety components.

This category is particularly important because safety components may be relatively small products, yet they can have a direct effect on the safety of a machine.

Article 2(c) defines a safety component through several criteria.

A component must:

• serve to fulfil a safety function;
• be independently placed on the market;
• have a failure and/or malfunction that endangers the safety of persons; and
• not be necessary for the machinery to function, or be replaceable by normal components without preventing the machinery from functioning.

This definition is much more useful than simply asking:

“Is this component related to safety?”

A component does not automatically become a safety component merely because it contributes to safety.

The legal criteria must be assessed.

Examples

The Directive’s Annex V contains an indicative list of safety components.

Depending on the specific product and its function, examples can include certain:

• protective devices;
• control devices;
• safety-related components;
• detection devices; and
• components intended to prevent or limit hazardous situations.

The list in Annex V is indicative rather than exhaustive.

This means that a manufacturer cannot conclude:

“My product is not listed in Annex V, therefore it cannot be a safety component.”

The actual definition in Article 2(c) remains decisive.

3.7 Lifting Accessories

The fourth category is lifting accessories.

These are products used to connect a load to lifting machinery or lifting equipment.

Examples may include equipment used between:

• a crane and a load;
• a lifting machine and a load; or
• another lifting system and the load.

The Machinery Directive treats lifting accessories as products in their own right.

This is important because they are often physically simple products compared with a complete lifting machine.

Nevertheless, their failure can have severe consequences.

For example, failure of a lifting accessory can result in:

• a load falling;
• crushing hazards;
• impact hazards;
• damage to equipment; or
• serious injury or death.

The manufacturer therefore has to consider the specific requirements applicable to lifting accessories rather than treating them merely as generic mechanical hardware.

3.8 Chains, Ropes and Webbing

Article 1 separately identifies:

chains, ropes and webbing

when they are designed and constructed for lifting purposes.

This is another example of why the scope of the Machinery Directive cannot be determined simply by looking at whether a product appears to be a “machine”.

A chain, rope or webbing product may not contain:

• an electric motor;
• electronics;
• software;
• moving machinery;
• or a conventional machine frame.

Nevertheless, if it falls within the relevant category, the Machinery Directive applies.

The manufacturer must therefore assess the intended use and the relevant characteristics of the product.

3.9 Removable Mechanical Transmission Devices

Another category is removable mechanical transmission devices.

These are devices intended to transmit power between machinery or a power source and machinery.

A typical example is a mechanical transmission device that can be removed from one machine and used to connect another machine or system.

The legal classification is important because such products can introduce mechanical hazards independently of the machine to which they are connected.

Relevant risks may include:

• entanglement;
• crushing;
• shearing;
• unexpected movement;
• component failure; and
• rotating parts.

The manufacturer therefore has to consider both the product itself and the intended operating conditions.

3.10 Partly Completed Machinery

The seventh category is partly completed machinery.

This is one of the most important concepts in the Machinery Directive and one of the areas that most frequently causes confusion.

Partly completed machinery is defined in Article 2(g) as an assembly that is almost machinery but cannot itself perform a specific application.

It is intended only to be incorporated into or assembled with other machinery or other partly completed machinery to form machinery covered by the Directive.

The distinction is therefore based on function and intended integration, not simply on whether the product is physically incomplete.

A product can be physically complete but still be partly completed machinery

This is a very important practical point.

A manufacturer should not automatically classify a product as a complete machine simply because:

• it is physically assembled;
• it contains all its mechanical parts;
• it has its own drive system; or
• it looks like a finished product.

The relevant question is:

Can the product itself perform a specific application, or is it intended only to be incorporated into another machine?

If the latter is true, the partly completed machinery provisions may be relevant.

Partly completed machinery is not treated in exactly the same way as complete machinery

This distinction has significant consequences for:

• documentation;
• instructions;
• the declaration supplied with the product;
• incorporation;
• final conformity assessment; and
• CE marking.

Partly completed machinery is therefore not simply a “machine without a CE mark.”

It is a distinct legal category with its own conformity framework.

3.11 The Difference Between Machinery and Partly Completed Machinery

The distinction can be simplified as follows.

Machinery

A machine is capable of performing its specific application as defined by the manufacturer, subject to the normal conditions of installation, connection or integration described by the Directive.

Partly completed machinery

A partly completed machine is intended to be incorporated into another machine or assembly and cannot itself perform a specific application.

This distinction becomes particularly important in industrial supply chains.

For example:

Manufacturer A

produces a motor-driven mechanical module.

↓

Manufacturer B

integrates that module into a complete production machine.

The legal classification of Manufacturer A’s product depends on its actual design, intended function and whether it can perform a specific application independently.

It cannot simply be decided by asking who ultimately owns or operates the finished product.

3.12 Products Explicitly Excluded from the Machinery Directive

Article 1(2) contains a substantial list of products that are excluded from the scope of the Machinery Directive.

These exclusions are just as important as the products that are included.

The current consolidated Directive excludes, among other things:

1. certain replacement safety components;
2. specific fairground and amusement-park equipment;
3. certain nuclear-purpose machinery;
4. weapons, including firearms;
5. specified means of transport;
6. seagoing vessels and mobile offshore units and machinery installed on them;
7. machinery specially designed for military or police purposes;
8. machinery specially designed for temporary research use in laboratories;
9. mine winding gear;
10. machinery intended to move performers during artistic performances;
11. certain electrical and electronic products; and
12. certain high-voltage electrical equipment.

These exclusions must be read carefully.

An exclusion does not necessarily mean:

“No EU legislation applies.”

It means:

“This particular product is excluded from the Machinery Directive.”

Another EU legal framework may still apply.

This distinction is critical.

3.13 Replacement Safety Components

The Directive specifically excludes safety components intended as spare parts to replace identical components and supplied by the manufacturer of the original machinery.

This is a narrow exclusion.

It should not be interpreted as:

“All spare parts are outside the Machinery Directive.”

The specific conditions of the exclusion matter.

For example, a replacement component supplied by an unrelated manufacturer may require a different assessment.

Likewise, replacing an original safety component with a substantially different component can raise separate conformity questions.

The exclusion therefore needs to be assessed against the exact supply situation.

3.14 Fairground and Amusement-Park Equipment

Specific equipment intended for use in fairgrounds and amusement parks is excluded from the Machinery Directive.

This is another example where a product may contain extensive machinery technology while being governed by a different regulatory framework.

The manufacturer should therefore not assume that the technical nature of the equipment alone determines the applicable legislation.

The intended application and the specific legal exclusion must also be considered.

3.15 Nuclear-Purpose Machinery

The Directive excludes machinery specially designed or put into service for nuclear purposes where failure could result in an emission of radioactivity.

This is a specific exclusion.

It does not mean that every machine used somewhere in the nuclear sector is automatically excluded.

The wording refers to machinery specially designed or put into service for nuclear purposes and where failure may result in a radioactive emission.

The exact facts therefore matter.

3.16 Weapons

Weapons, including firearms, are expressly excluded from the Machinery Directive.

Again, the practical consequence is not that such products are unregulated.

They are subject to other legal frameworks.

This illustrates a broader principle:

An exclusion from one EU product directive does not automatically mean an exclusion from European or national regulation altogether.

3.17 Means of Transport

The Machinery Directive contains a detailed exclusion for several categories of transport equipment.

These include, subject to the conditions and exceptions in Article 1:

• agricultural and forestry tractors;
• certain motor vehicles and their trailers;
• certain two- and three-wheel vehicles;
• motor vehicles exclusively intended for competition; and
• means of transport by air, water and rail.

The exclusion is particularly important because machinery can be mounted on vehicles.

The Directive expressly maintains certain machinery mounted on otherwise excluded vehicles within its scope.

This means that the correct question is not simply:

“Is the machine mounted on a vehicle?”

The manufacturer must determine:

1. what the vehicle is;
2. whether the vehicle itself falls under the exclusion;
3. whether the machinery mounted on it is separately covered; and
4. which legal framework governs each part.

This is an excellent example of why scope assessment requires a legal analysis rather than a simple product-name lookup.

3.18 Ships and Mobile Offshore Units

Seagoing vessels and mobile offshore units, together with machinery installed on board them, are excluded from the Machinery Directive.

Again, this is a specific legal exclusion.

It should not be generalized to every type of offshore or marine equipment without checking the exact wording and the applicable alternative legislation.

3.19 Military and Police Machinery

Machinery specially designed and constructed for military or police purposes is excluded.

The wording is significant.

The exclusion relates to machinery specially designed and constructed for those purposes.

A commercially available machine that happens to be purchased by a police authority is therefore not automatically excluded simply because its customer is a police organisation.

The intended design and construction of the product matter.

3.20 Research Machinery for Temporary Laboratory Use

Machinery specially designed and constructed for research purposes for temporary use in laboratories is also excluded.

This exclusion is narrower than it may initially appear.

It does not mean:

“Any laboratory machine is outside the Machinery Directive.”

The machinery must satisfy the specific conditions concerning:

• special design and construction;
• research purposes; and
• temporary laboratory use.

A standard commercial machine used in a laboratory is therefore not automatically excluded.

3.21 Mine Winding Gear

Mine winding gear is expressly excluded from the Machinery Directive.

This is another product category governed by a more specific regulatory framework.

3.22 Machinery Used to Move Performers

Machinery intended to move performers during artistic performances is also excluded.

This includes specialised machinery used as part of stage or artistic performances.

Again, the intended function is critical.

A conventional lifting or movement machine used in a theatre is not automatically outside the Machinery Directive simply because it is located in a theatre.

The specific purpose described by the exclusion must be considered.

3.23 Certain Electrical and Electronic Products

The Machinery Directive also excludes certain electrical and electronic products, including:

• household appliances intended for domestic use;
• audio and video equipment;
• information technology equipment;
• ordinary office machinery;
• low-voltage switchgear and control gear; and
• electric motors,

subject to the conditions specified in Article 1.

This is particularly relevant because some of these products can contain moving parts.

A manufacturer should therefore not conclude:

“The product has a motor, so the Machinery Directive applies.”

The specific product category and the applicable exclusion must be assessed.

3.24 Certain High-Voltage Electrical Equipment

The Directive also excludes certain types of high-voltage electrical equipment, specifically:

• switchgear and control gear; and
• transformers.

Again, this does not mean that such equipment is unregulated.

It means that these products are outside the scope of the Machinery Directive.

3.25 A Product Can Be Subject to Several Legal Regimes

One of the most important lessons from Article 1 is that scope determination should not be reduced to a yes/no question:

“Is it covered by the Machinery Directive?”

A better approach is:

“Which EU legislation applies to each relevant aspect of the product?”

For example, a product might involve:

• machinery legislation;
• electrical safety legislation;
• electromagnetic compatibility requirements;
• radio requirements;
• pressure equipment requirements;
• environmental legislation;
• hazardous-substance requirements; or
• cybersecurity requirements.

The exact combination depends on the product.

This is why a regulatory mapping exercise should normally precede the detailed technical compliance assessment.

3.26 The Importance of Article 2 Definitions

Article 2 is essential because Article 1 only tells us which categories exist.

Article 2 tells us what those categories mean.

Among the defined terms are:

• machinery;
• interchangeable equipment;
• safety component;
• lifting accessory;
• chains, ropes and webbing;
• removable mechanical transmission device;
• partly completed machinery;
• manufacturer;
• authorised representative;
• putting into service;
• harmonised standard;
• essential health and safety requirements; and
• other terms used throughout the Directive.

The classification should therefore be based on the legal definitions rather than commercial terminology.

A company might call something:

“module”

while another company calls the same type of product:

“machine”

or:

“subassembly.”

None of these commercial names determines the legal classification.

The actual characteristics, function and intended use determine the classification.

3.27 The Product Name Is Not the Legal Classification

This is worth emphasizing because it is a frequent source of errors.

Consider three hypothetical products:

Product A – “Automation Module”

The company sells a motor-driven assembly that is intended only to be integrated into a larger production machine and cannot perform a specific application by itself.

The product may potentially be partly completed machinery.

Product B – “Complete Handling System”

The product is delivered as an operational machine designed to perform a defined handling function.

It may qualify as machinery.

Product C – “Safety Sensor”

The product is independently marketed and its failure could endanger persons because it performs a safety function.

It may potentially qualify as a safety component.

The commercial names do not decide the answer.

The legal characteristics do.

3.28 The Intended Use Is Critical

The Machinery Directive repeatedly requires manufacturers to consider how the product is intended to be used.

This is particularly relevant for:

• machinery classification;
• risk assessment;
• reasonably foreseeable misuse;
• interchangeable equipment;
• lifting equipment;
• safety components; and
• partly completed machinery.

A product can therefore potentially have different compliance implications depending on its intended application.

For example, a drive unit sold as a general industrial component may be assessed differently from a complete system specifically designed to perform a defined mechanical function.

The manufacturer’s documentation should therefore clearly describe:

• intended purpose;
• intended application;
• operating conditions;
• interfaces;
• limitations;
• foreseeable uses; and
• relevant restrictions.

3.29 A Practical Scope Assessment

A practical manufacturer assessment can be structured as follows.

Question 1

What exactly is the product?

Describe its physical and functional characteristics.

Question 2

Does it match one of the seven categories in Article 1(1)?

Check:

• machinery;
• interchangeable equipment;
• safety component;
• lifting accessory;
• chain, rope or webbing;
• removable mechanical transmission device;
• partly completed machinery.

Question 3

Does the product meet the relevant Article 2 definition?

Do not rely on the product name.

Question 4

Is the product explicitly excluded under Article 1(2)?

Check the exclusions carefully.

Question 5

Does another EU legal act apply more specifically?

This is particularly important for products with multiple technical characteristics.

Question 6

Is the product complete or partly completed?

This affects the conformity framework and documentation.

Question 7

Is the product part of a larger assembly of machinery?

If so, determine whether the individual machines function as an integrated whole.

Question 8

Who is placing the product on the market and in what role?

Manufacturer, importer, integrator or another economic operator?

Only after these questions have been answered should the detailed technical conformity assessment begin.

3.30 Common Scope Classification Errors

Scope mistakes can have significant consequences.

Error 1: “It has moving parts, therefore it is machinery.”

Not necessarily.

The complete legal definition must be considered.

Error 2: “It is only a module, so the Machinery Directive does not apply.”

Not necessarily.

It may be partly completed machinery or another product category within Article 1.

Error 3: “It has its own CE mark, so integration is automatically compliant.”

Not necessarily.

An assembly of machinery may create additional conformity obligations.

Error 4: “It is a spare part, so it is outside the Directive.”

Not necessarily.

The specific replacement-component exclusion has conditions.

Error 5: “It is used by the police, so it is excluded.”

Not necessarily.

The exclusion applies to machinery specially designed and constructed for military or police purposes.

Error 6: “It is used in a laboratory, so it is excluded.”

Not necessarily.

The research-machinery exclusion contains specific conditions.

Error 7: “It is mounted on a vehicle, so the Machinery Directive does not apply.”

Not necessarily.

The transport exclusions and their exceptions must be examined carefully.

Error 8: “Another EU Directive applies, so the Machinery Directive does not apply at all.”

Not necessarily.

The relationship between the different legal acts must be assessed for the relevant hazards and product aspects.

3.31 Scope Determination Should Be Documented

The scope decision itself should be documented.

A manufacturer should be able to explain why the product was classified as:

• machinery;
• partly completed machinery;
• safety component;
• interchangeable equipment;
• lifting accessory;
• another category; or
• outside the scope of the Machinery Directive.

This can be particularly valuable when the classification is not obvious.

A short internal scope assessment can record:

Question	Assessment
Product	Description of the product
Intended purpose	Defined application
Moving parts	Yes / No
Drive system	Type and source
Article 1 category	Applicable category
Article 2 definition	Relevant definition
Exclusions	Applicable / not applicable
Other EU legislation	Identified legislation
Final classification	Regulatory conclusion
Rationale	Explanation and evidence

This creates a traceable starting point for the remainder of the conformity assessment.

3.32 The Regulatory Scope Is the Foundation of the Compliance Process

The importance of correct scope classification cannot be overstated.

If the classification is wrong, subsequent decisions may also be wrong.

For example:

Wrong product classification

↓

Wrong legal framework

↓

Wrong essential requirements

↓

Wrong standards

↓

Wrong risk assessment

↓

Wrong conformity assessment procedure

↓

Incomplete technical documentation

↓

Potentially invalid conformity claim

This is why professional compliance work should begin with scope determination.

The question of which standard to use comes later.

The question of which tests to perform comes later.

The question of whether a notified body is required comes later.

First:

What is the product from a regulatory perspective?

3.33 ScopeRight Perspective: Turning Product Information into a Regulatory Scope

This is also where a structured compliance workflow can provide significant value.

Instead of asking a manufacturer to start with a long list of standards, a scope assessment can begin with product-specific questions:

• What does the product do?
• Does it have moving parts?
• What type of drive system does it use?
• Is it a complete machine?
• Is it intended to be integrated into another machine?
• Is it safety-related?
• Is it used for lifting?
• Is it supplied as interchangeable equipment?
• Is it part of a larger automated system?
• Is it mounted on a vehicle?
• Is it intended for laboratory, military or other specialised applications?
• Which other technologies are incorporated?
• Which markets are targeted?

The answers can then be used to establish a regulatory classification before proceeding to the detailed technical assessment.

This is the logical foundation of an efficient machinery compliance process.

3.34 Summary

The scope of the Machinery Directive is significantly broader than the everyday meaning of the word “machine”.

Article 1 covers seven categories:

1. machinery;
2. interchangeable equipment;
3. safety components;
4. lifting accessories;
5. chains, ropes and webbing;
6. removable mechanical transmission devices; and
7. partly completed machinery.

At the same time, Article 1 contains important exclusions covering specific products and product categories.

Article 2 then provides the legal definitions needed to classify the products correctly.

The most important practical lessons are:

• Do not classify a product based on its commercial name.
• Do not assume that moving parts automatically mean machinery.
• Do not assume that a module is automatically outside the Directive.
• Distinguish complete machinery from partly completed machinery.
• Assess assemblies of machinery as integrated systems where appropriate.
• Check the explicit exclusions carefully.
• Consider other applicable EU legislation.
• Document the scope decision before starting the detailed conformity assessment.

The scope assessment is therefore not merely an administrative first step.

It is the foundation on which the entire machinery compliance process is built.

Official Sources

• Directive 2006/42/EC on machinery – consolidated version, including Article 1 (Scope) and Article 2 (Definitions). EUR-Lex – Directive 2006/42/EC
• European Commission – Machinery, including the official Guide to application of the Machinery Directive 2006/42/EC, Edition 2.3, April 2024. European Commission – Machinery
• EUR-Lex – Article 2 definitions, including machinery, interchangeable equipment, safety components and related categories. EUR-Lex – Machinery Directive Definitions

4. The Essential Health and Safety Requirements

Once it has been established which products fall within the scope of the Machinery Directive, the next fundamental question is:

What requirements must a machine meet to comply with the Machinery Directive and be placed on the EU market?

The answer is found primarily in Annex I of Machinery Directive 2006/42/EC.

Annex I contains the Essential Health and Safety Requirements (EHSRs) that must be taken into account during the design and construction of machinery.

These requirements are mandatory. At the same time, the Machinery Directive is designed around a technology-neutral approach: it defines the safety objectives that machinery must achieve rather than prescribing one specific technical solution for every machine.

How those objectives are achieved depends on factors such as:

• the specific machine,
• its intended use,
• reasonably foreseeable misuse,
• the hazards associated with the machine,
• the results of the risk assessment,
• and the state of the art.

This is why the Machinery Directive cannot simply be treated as a checklist of technical specifications.

4.1 Annex I is the core of the technical requirements

Annex I is titled:

“Essential health and safety requirements relating to the design and construction of machinery.”

It is structured into several sections.

The first section contains general requirements applicable to machinery in general.

Additional sections address specific types of machinery and specific hazards, including, for example:

• machinery for the food, cosmetics and pharmaceutical industries,
• portable and hand-held machinery,
• machinery involving particular hazards associated with mobility,
• lifting machinery,
• machinery intended for underground work,
• machinery used for lifting persons,
• and other specific categories.

An important point appears already in the General Principles of Annex I:

The manufacturer must examine the entire Annex I in order to determine which requirements are applicable to the particular machine.

The manufacturer must therefore not simply select one or two sections that appear relevant and ignore the remainder.

4.2 The requirements are mandatory

The Essential Health and Safety Requirements are not recommendations.

They are legal requirements.

At the same time, Annex I recognises that the state of the art develops over time and that it may not always be possible to achieve the objectives set out in the requirements to the same extent for every machine.

In such cases, the machinery must be designed and constructed, as far as possible, to approach those objectives.

This leads to an important principle:

“We have always designed it this way” is not, by itself, a compliance justification.

The design needs to take the relevant state of the art into account.

4.3 The risk assessment determines which requirements are relevant

One of the central concepts of the Machinery Directive is the relationship between:

risk assessment

and

Essential Health and Safety Requirements.

The manufacturer must first carry out a risk assessment.

This includes:

1. determining the limits of the machinery,
2. identifying the intended use and reasonably foreseeable misuse,
3. identifying the hazards that may be generated by the machinery,
4. estimating the risks associated with those hazards,
5. evaluating whether risk reduction is necessary,
6. identifying and implementing appropriate protective measures,
7. and verifying that the resulting risks have been adequately reduced.

This is not intended to be a one-time exercise performed at the end of the project.

It is an iterative process.

A simplified representation is:

Define the machine

↓

Identify hazards

↓

Assess risks

↓

Define protective measures

↓

Modify the design

↓

Reassess the risks

↓

Verify the protective measures

↓

Document residual risks

The risk assessment should therefore influence the machine’s design rather than simply document a design that has already been completed.

4.4 The limits of the machinery must be determined

Before hazards can be systematically assessed, the limits of the machinery need to be established.

This includes considerations such as:

• intended use,
• operating conditions,
• foreseeable operating modes,
• installation,
• commissioning,
• normal operation,
• adjustment,
• maintenance,
• cleaning,
• repair,
• transportation,
• dismantling,
• and disposal.

The manufacturer must also consider reasonably foreseeable misuse.

The Machinery Directive defines reasonably foreseeable misuse as the use of machinery in a way that is not intended by the manufacturer but may result from readily predictable human behaviour.

This is important in practice.

A risk assessment cannot simply state:

“The operator is not allowed to do that.”

If a particular form of misuse is reasonably foreseeable and creates a hazard, it needs to be considered.

4.5 Hazard and risk are not the same thing

The terms hazard and risk should be clearly distinguished.

A hazard is a potential source of injury or damage to health.

Risk, on the other hand, takes into account factors such as:

• the probability that harm will occur,
• and the severity of that harm.

For example:

A rotating shaft represents a hazard.

The associated risk depends on factors such as:

• whether a person can access the shaft,
• the rotational speed,
• the available forces,
• the frequency of exposure,
• the likelihood of contact,
• and the possible severity of an injury.

This distinction is fundamental to a meaningful risk assessment.

4.6 The principle of safety integration

The Machinery Directive follows the principle of safety integration.

Machinery must be designed and constructed so that it can be operated, adjusted and maintained without exposing persons to unnecessary risks under the intended conditions of use and taking reasonably foreseeable misuse into account.

The manufacturer must follow a defined hierarchy when selecting risk-reduction measures.

This hierarchy is one of the most important concepts in the Machinery Directive.

4.7 The three-step method of risk reduction

The Machinery Directive establishes a clear order of priority.

1. Eliminate hazards or reduce risks through inherently safe design

The first objective should be to eliminate the hazard or reduce the associated risk through the design itself.

2. Apply safeguarding and protective measures

If hazards cannot be sufficiently eliminated through design, appropriate guards and protective devices must be used.

3. Inform users about residual risks

If risks remain after the design and protective measures have been applied, users must be informed about those residual risks.

This may include:

• warnings,
• information in the instructions,
• requirements for personal protective equipment,
• or other safety information.

The order matters.

A warning label should not be the primary solution where a dangerous condition could reasonably have been eliminated through the design.

4.8 Example: Access to a dangerous moving component

Consider a machine containing a rapidly rotating shaft.

Poor solution

“Warning! Rotating parts – do not touch.”

This relies primarily on user behaviour.

Better solution

The shaft is positioned or designed so that access is prevented as far as reasonably possible.

Additional protection

Where access is necessary, a suitable guard can be provided.

Further protection

If opening the guard creates a dangerous situation, an interlocking system may prevent or stop the hazardous movement.

The appropriate technical solution depends on the machine and the results of the risk assessment.

The underlying principle remains:

Eliminate or reduce the hazard at its source before relying on warnings or user behaviour.

4.9 Mechanical hazards

A substantial part of Annex I addresses hazards associated with mechanical movement and forces.

Examples include:

• crushing,
• shearing,
• cutting,
• entanglement,
• drawing-in,
• impact,
• stabbing or puncture,
• friction,
• abrasion,
• falling objects,
• ejection of components,
• and loss of stability.

The specific hazards depend heavily on the machine.

A machine containing:

• rotating cutting tools

will have a very different hazard profile from:

• a hydraulic press,

or:

• an automated robotic system.

This is why there is no universal risk-assessment checklist that can simply be applied unchanged to every machine.

4.10 Stability

Machinery must be designed and constructed so that it has sufficient stability under the intended conditions of operation.

Depending on the machine, this can involve:

• its own weight,
• movement,
• external forces,
• loads,
• operating positions,
• and other foreseeable conditions.

A machine that can tip over, collapse or become unstable can create serious hazards.

Stability therefore needs to be considered as part of both the design and the risk assessment.

4.11 Breakage or failure of components

Annex I also addresses mechanical strength and the behaviour of components under foreseeable loads.

Components must be designed and manufactured so that they can withstand the stresses to which they are expected to be subjected.

Depending on the application, this may include:

• static loads,
• dynamic loads,
• fatigue,
• wear,
• corrosion,
• temperature,
• vibration,
• and other environmental influences.

The assessment should therefore not be limited to a single ideal operating condition.

Foreseeable operating situations must also be considered.

4.12 Falling or ejected objects

Machinery can create hazards not only through its own movement.

Workpieces, tools, components or fragments may:

• fall,
• break,
• become detached,
• or be ejected.

These risks need to be addressed through the machine design.

Depending on the application, measures may include:

• guards,
• protective enclosures,
• retaining devices,
• secure fastening,
• interlocking,
• or other protective measures.

4.13 Moving parts

Moving parts are one of the most common sources of machinery hazards.

Annex I requires moving parts to be designed and positioned so that hazards are avoided.

Where this cannot be achieved, suitable guards or protective devices must be used.

It is also important not to consider only the main movement.

Hazards can also arise from:

• secondary movements,
• unexpected movement,
• stored energy,
• rebound,
• reverse movement,
• or movement continuing after the machine has been switched off.

This is particularly important when considering run-down time.

A motor may be switched off while a tool or rotating mass continues moving because of stored kinetic energy.

Simply removing power from the motor therefore does not necessarily mean that the hazard has disappeared.

4.14 Guards and protective devices

Guards are an important part of many machinery safety concepts.

The Machinery Directive distinguishes between guards and protective devices.

A guard is a physical barrier designed to provide protection.

A protective device is a device that reduces risk, either on its own or together with a guard.

Examples can include:

• fixed guards,
• movable guards,
• interlocking devices,
• light curtains,
• pressure-sensitive devices,
• two-hand controls,
• and other safety-related devices.

The appropriate solution depends on the hazard and the results of the risk assessment.

4.15 Control systems must operate safely

Modern machinery is not only mechanical.

Control systems frequently perform safety-related functions.

Annex I therefore contains requirements concerning control systems.

A control system must not create hazardous situations.

Depending on the machine, relevant situations can include:

• control-system failure,
• loss of energy,
• restoration of energy,
• faults in the control system,
• unintended starting,
• unexpected movement,
• changes in operating conditions,
• and failure of safety-related functions.

This becomes particularly important for automated machinery.

4.16 Preventing unexpected start-up

Machinery must not unexpectedly restart where this could create a hazard.

This can be relevant following:

• a power failure,
• maintenance,
• opening a guard,
• resetting a safety system,
• or restoration of the energy supply.

The exact technical implementation depends on the machine and its risk assessment.

The fundamental objective is:

Restoring power or another operating condition must not by itself cause a hazardous restart.

4.17 Emergency stop

Many machines require an emergency-stop function.

The Machinery Directive contains requirements concerning emergency-stop devices.

The emergency stop must be capable of bringing the machine to a safe state appropriate to the hazards involved.

It is important to understand that:

An emergency stop is not automatically equivalent to every other type of stop function.

Its implementation must reflect the intended safety function and the characteristics of the machine.

4.18 Energy supply

Annex I also considers hazards associated with different forms of energy.

These can include:

• electrical energy,
• hydraulic energy,
• pneumatic energy,
• mechanical energy,
• thermal energy,
• and stored energy.

A machine may remain hazardous after it has been switched off if energy remains stored.

Examples include:

• hydraulic pressure,
• compressed air,
• loaded springs,
• suspended loads,
• rotating masses,
• or electrical energy stored in capacitors or batteries.

The machine therefore needs to be designed so that hazardous stored energy can be safely isolated, discharged or otherwise controlled.

4.19 Maintenance and servicing

Safety does not end when normal production stops.

Machinery must also be designed so that:

• maintenance,
• cleaning,
• adjustment,
• inspection,
• repair,
• and servicing

can be carried out safely.

This is particularly important because many machinery accidents occur during activities such as:

• troubleshooting,
• cleaning,
• tool changes,
• maintenance,
• repair,
• and setup.

The risk assessment should therefore consider the relevant phases of the machine’s lifecycle rather than focusing exclusively on normal automated operation.

4.20 Ergonomics

The Machinery Directive also addresses ergonomic considerations.

Machinery must be designed so that discomfort, fatigue and physical or psychological stress are reduced as far as possible.

Depending on the application, considerations can include:

• posture,
• physical effort,
• repetitive movements,
• reach,
• visibility,
• control forces,
• workstation layout,
• and the positioning of operating elements.

The European Commission also provides guidance specifically addressing the ergonomic requirements of Annex I.

Ergonomics is therefore not simply a question of operator comfort.

It can form part of the machinery’s safety and health requirements.

4.21 Lighting

Machinery may need suitable lighting where normal ambient lighting is insufficient.

The objective is not simply to provide maximum illumination.

Lighting should allow:

• safe operation,
• adequate visibility of hazardous areas,
• safe maintenance,
• and clear observation of relevant operating conditions.

At the same time, lighting must not itself create hazards such as dangerous glare or misleading shadows.

4.22 Temperatures and fire hazards

Machinery can create hazards through high or low temperatures.

Examples include:

• hot surfaces,
• hot liquids,
• steam,
• exhaust gases,
• and extremely cold components.

The design should reduce the risk of burns, scalding or other temperature-related injuries.

Fire hazards must also be considered where relevant.

This can involve:

• materials,
• heat generation,
• cooling,
• flammability,
• electrical components,
• process materials,
• and the operating environment.

4.23 Noise

Noise is another important hazard addressed by the Machinery Directive.

Machinery must be designed and constructed so that risks resulting from airborne noise are reduced as far as possible.

Again, the hierarchy of risk reduction applies.

The preferred approach is to reduce noise through the machine design itself rather than relying solely on warnings or personal protective equipment.

4.24 Vibration

Vibration can also represent a significant hazard.

This is particularly relevant for:

• hand-held machinery,
• portable machinery,
• mobile machinery,
• and machinery generating substantial mechanical vibration.

Depending on the application, vibration can affect:

• the operator,
• the surrounding environment,
• the machine itself,
• or the reliability of safety-related components.

4.25 Radiation

Depending on the machine, radiation may also need to be considered.

Potential sources include:

• ionising radiation,
• non-ionising radiation,
• laser radiation,
• optical radiation,
• and electromagnetic radiation.

The applicable requirements depend on the specific source and associated hazard.

A machine incorporating a laser, for example, requires a fundamentally different assessment from a conventional mechanical machine.

4.26 Hazardous substances and emissions

Machinery can release substances or operate with hazardous materials.

Examples include:

• dust,
• fumes,
• vapours,
• gases,
• aerosols,
• and other hazardous emissions.

Where such hazards exist, the design should prevent or minimise exposure as far as reasonably possible.

This may involve:

• containment,
• extraction,
• filtration,
• sealing,
• process design,
• or other protective measures.

4.27 Information and warnings

Not every risk can be completely eliminated through design.

The Machinery Directive therefore also requires appropriate information to be provided to users.

This can include:

• warnings,
• markings,
• instructions,
• information about residual risks,
• safe operating procedures,
• and requirements for protective equipment.

But an important principle should be remembered:

Information is the third step of risk reduction — not the first.

A manufacturer cannot normally make a preventable hazard acceptable simply by adding a warning label.

4.28 The instructions are part of the safety concept

The instructions are not simply an administrative document produced after the machine has been completed.

They form part of the overall safety concept.

The Machinery Directive contains extensive requirements concerning the information that must be provided to users.

Depending on the machine, this can include:

• intended use,
• reasonably foreseeable misuse,
• installation,
• commissioning,
• operation,
• adjustment,
• maintenance,
• cleaning,
• troubleshooting,
• residual risks,
• protective measures,
• and other safety-related information.

The instructions must therefore accurately reflect the actual machine, its risk assessment and its protective measures.

4.29 Marketing information must not contradict the instructions

A particularly interesting requirement appears in Annex I, Section 1.7.4.3.

Sales literature describing the machinery must not contradict the instructions with regard to health and safety aspects.

Information concerning performance characteristics and emissions must also be consistent with the corresponding information in the instructions.

This means:

Marketing is not completely separate from compliance.

For example, if a product brochure promotes a machine for an application that is not covered by its safety assessment or instructions, this can create a compliance problem.

4.30 Not every requirement applies to every machine

A common mistake is to treat Annex I as a checklist where every single requirement must be marked:

“Compliant.”

That is not how it works.

The requirements apply depending on whether the relevant hazard or situation exists for the particular machine.

At the same time, the manufacturer must systematically examine the requirements to determine which are applicable.

For example:

A conventional stationary machine with no lifting function does not need to be treated as lifting machinery.

However, a machine that does perform lifting operations must address the additional applicable requirements.

The key is therefore not:

“Have we checked every box?”

but:

“Have we systematically determined which requirements apply, and can we justify our decisions?”

4.31 Additional requirements for specific machinery

Annex I contains additional requirements for specific types of machinery.

For example:

Machinery for food, cosmetics and pharmaceutical products

Additional considerations include hygiene and contamination-related risks.

Mobile machinery

Additional hazards arise from movement, driving and the interaction between the machine and its surroundings.

Lifting machinery

Additional requirements address hazards associated with:

• lifting,
• loads,
• falling loads,
• stability,
• and related operations.

Machinery for lifting persons

Additional requirements apply because failure can result in falls and other particularly serious hazards.

The correct selection of these additional requirements must be based on the characteristics of the machinery and the risk assessment.

4.32 Turning Annex I into a practical compliance matrix

For practical compliance work, it is useful to translate Annex I into a requirements matrix.

For example:

Annex I requirement	Applicable?	Reason	Evidence	Status
1.1.2 Safety integration	Yes	General machinery requirement	Risk assessment / design review	Open
1.3.2 Risk of breakage	Yes	Rotating assembly	Calculation / test	Compliant
1.3.7 Moving parts	Yes	Automated axis	Guarding concept	Compliant
1.4 Guards	Yes	Access to hazard zone	Design / verification	Compliant
1.5.1 Electrical energy	Yes	Mains-powered machine	Electrical assessment	Compliant
1.5.6 Fire	Yes	High operating temperature	Risk assessment	Open
Mobility requirements	No	Stationary machine	Documented justification	N/A
Lifting requirements	No	No lifting function	Documented justification	N/A

Such a matrix makes it possible to see:

• which requirements are applicable,
• which are not applicable,
• why they are not applicable,
• how compliance is demonstrated,
• and what remains open.

This is considerably more robust than simply stating:

“The machine complies with Annex I.”

4.33 Requirements should be linked to evidence

A strong compliance file should not simply state:

“Requirement fulfilled.”

It should ideally also answer:

How was compliance demonstrated?

Depending on the requirement, evidence may include:

• technical drawings,
• calculations,
• design specifications,
• risk assessments,
• test reports,
• measurements,
• software or control-system analysis,
• validation records,
• technical specifications,
• inspections,
• functional tests,
• or applicable standards.

This creates a clear chain:

Requirement → Hazard/Risk → Protective Measure → Evidence

That connection is extremely valuable when reviewing a machine’s compliance.

4.34 The role of harmonised standards

This is where harmonised European standards become important.

The Machinery Directive establishes the legal requirements.

Harmonised standards can provide detailed technical specifications and methods that manufacturers can use to address those requirements.

The European Commission publishes information on harmonised standards under the Machinery Directive, including references published in the Official Journal of the European Union.

The distinction is therefore important:

Machinery Directive

→ legal requirements

Harmonised standard

→ technical specification that can support conformity and, where applicable, the presumption of conformity for the requirements covered by the standard.

The relationship between legislation and standards will be examined in much greater detail later in this guide.

4.35 A standard does not replace the risk assessment

A common misconception is:

“We use the correct machinery standard, so we do not need a risk assessment.”

That is incorrect.

The risk assessment remains a fundamental part of the compliance process.

Even where a harmonised standard is used, the manufacturer still needs to understand:

• which hazards exist,
• which requirements are applicable,
• which protective measures have been implemented,
• whether the standard actually covers the machine,
• and whether additional risks remain.

The European Commission’s guidance reinforces the importance of considering the applicable requirements based on the machinery’s risk assessment.

4.36 The relationship between risk assessment, standards and Annex I

The correct relationship can be simplified as follows:

Product and intended use

↓

Risk assessment

↓

Hazards

↓

Applicable Annex I requirements

↓

Technical solutions

↓

Harmonised standards as a technical tool

↓

Design and protective measures

↓

Verification / validation

↓

Technical documentation

This illustrates an important principle:

Standards are a tool within the compliance process — they are not the starting point of the entire process.

4.37 Why a list of standards is not enough

A manufacturer may have an extensive list of standards and still fail to address important requirements.

For example:

• The wrong machinery category may have been assumed.
• A relevant hazard may have been overlooked.
• An outdated edition of a standard may have been used.
• The standard may not cover the entire machine.
• A limitation in the standard may have been ignored.
• A specific characteristic of the machine may not be covered.
• An additional Annex I requirement may have been overlooked.

Therefore:

Standards list ≠ conformity

A much stronger approach is:

Requirement + risk + technical solution + evidence = defensible compliance

4.38 Common practical mistakes

Several recurring problems appear when Annex I is applied in practice.

1. The risk assessment is performed too late

The machine is designed first, and the risk assessment is created afterwards merely to document the existing design.

2. Only normal operation is assessed

Maintenance, cleaning, setup, troubleshooting and transport are insufficiently considered.

3. Foreseeable misuse is ignored

The assessment only considers what the operator is officially instructed to do.

4. Warnings are used instead of design measures

Warning labels are relied upon where a hazard could have been reduced through design or guarding.

5. The complete machine is not assessed

Individual components are assessed, but interactions between components and systems are overlooked.

6. Control-system risks are underestimated

Particularly in automated machinery, software and control-system failures can be safety-relevant.

7. Residual risks are poorly documented

Risks remaining after protective measures have been implemented are not adequately communicated.

8. Marketing and technical documentation contradict one another

The application promoted by sales material does not correspond to the application assessed from a safety perspective.

4.39 Practical example

Consider an automated packaging machine.

The machine contains:

• motors,
• conveyors,
• pneumatic cylinders,
• electrical controls,
• moving grippers,
• guards,
• sensors,
• and an automatic feeding system.

A superficial assessment might conclude:

“The machine is CE marked and complies with Standard XYZ.”

A professional assessment starts differently.

Step 1 – Define the limits

How is the machine intended to be used?

Who operates it?

Who maintains it?

What materials are processed?

Step 2 – Identify hazards

For example:

• crushing,
• shearing,
• entanglement,
• unexpected start-up,
• pneumatic energy,
• electrical energy,
• noise,
• hot surfaces.

Step 3 – Assess the risks

Which hazards are relevant?

How severe could the resulting harm be?

How likely is exposure?

Step 4 – Define protective measures

For example:

• fixed guards,
• interlocked doors,
• safety-related stopping,
• controlled restart,
• safe pneumatic systems,
• movement limitation.

Step 5 – Map requirements

Identify the applicable requirements in Annex I.

Step 6 – Establish evidence

For every relevant requirement, determine how compliance will be demonstrated.

Step 7 – Verify and validate

Verify that the implemented protective measures actually achieve their intended safety function.

This turns an abstract legal requirement into a structured engineering process.

4.40 The most important mindset for manufacturers

The Machinery Directive should not be viewed as a collection of paragraphs that need to be “checked off” at the end of a project.

It should be understood as a design and safety framework.

The key question is not:

“Which documents do we need for CE marking?”

The better question is:

“How do we ensure that the machine is designed, constructed, operated and maintained safely throughout its intended lifecycle?”

That is why the risk assessment is positioned so early in the compliance process.

4.41 From requirements to risk assessment

Once the Essential Health and Safety Requirements are understood, the next critical question is:

How is a machinery risk assessment actually performed?

The Machinery Directive establishes the fundamental logic:

Determine the limits

→ Identify hazards

→ Estimate and evaluate risks

→ Implement protective measures

→ Reassess the remaining risks

→ Document residual risks

The risk assessment is therefore the central process connecting the legal requirements of Annex I with the actual engineering of the machine.

The next chapter will examine the machinery risk assessment in detail, including:

• determining machine limits,
• intended use,
• reasonably foreseeable misuse,
• hazard identification,
• risk estimation,
• risk evaluation,
• risk reduction,
• verification,
• residual risks,
• and documentation.

5. Machinery Risk Assessment

Risk assessment is one of the most important elements of the entire machinery conformity process.

It is not simply a document created at the end of a project to justify CE marking. Instead, it should influence the design and development of the machinery from an early stage.

Machinery Directive 2006/42/EC requires the manufacturer to carry out a risk assessment in order to determine the health and safety requirements applicable to the machinery and then implement appropriate protective measures. The basic methodology is established in the General Principles of Annex I.

For practical implementation, manufacturers commonly use EN ISO 12100 – Safety of machinery – General principles for design – Risk assessment and risk reduction. The standard provides a systematic methodology for hazard identification, risk estimation, risk evaluation and risk reduction.

An important principle is:

Risk assessment is not a form. It is a structured decision-making process.

5.1 Why Is a Risk Assessment Required?

Machinery can create very different hazards.

A:

• CNC machine,
• packaging machine,
• construction machine,
• robot cell,
• lifting machine,
• food-processing machine,
• or automated production line

may have completely different risks.

The Machinery Directive therefore cannot prescribe one complete set of protective measures for every possible machine.

Instead, the manufacturer must identify the specific hazards associated with its machinery and determine appropriate protective measures based on those hazards.

The risk assessment essentially answers three questions:

1. What could be dangerous about this machine?
2. How significant is each risk?
3. What measures are necessary to reduce the risk?

5.2 Risk Assessment Is an Iterative Process

A common misconception is that the risk assessment is performed once and then considered finished.

In practice, it is an iterative process.

For example:

Initial design

↓

Hazard identified

↓

Protective measure defined

↓

Design modified

↓

New or changed hazard?

↓

Risk reassessed

↓

Protective measure verified

↓

Residual risk determined

This process may continue throughout several stages of product development.

A change to the machinery can alter an existing risk or introduce a completely new hazard.

5.3 The Basic Methodology

The risk assessment can be broadly divided into the following steps:

Step 1

Determine the limits of the machinery

Step 2

Identify hazards

Step 3

Estimate risks

Step 4

Evaluate risks

Step 5

Determine protective measures

Step 6

Reassess the risks after protective measures have been implemented

Step 7

Document and communicate residual risks

This sequence reflects the fundamental logic of the Machinery Directive and the methodology described in EN ISO 12100.

5.4 Step 1 – Determine the Limits of the Machinery

Before a hazard can be assessed, it must first be established what exactly is being assessed.

The limits of the machinery should be clearly defined.

This includes, among other things:

• intended use,
• intended users,
• operating conditions,
• energy supply,
• operating modes,
• spatial limits,
• temporal limits,
• lifecycle phases,
• interfaces with other machinery,
• and reasonably foreseeable misuse.

This is particularly important for complex machinery and production systems.

5.5 Intended Use

The intended use describes what the machinery is designed to do.

A general product description is usually not sufficient.

A useful description should address questions such as:

• What materials are processed?
• What workpieces are used?
• What speed is intended?
• What loads are moved?
• Which operating modes are available?
• Who is permitted to operate the machinery?
• What environment is intended?
• What process conditions apply?

The more precisely the intended use is defined, the more meaningful the risk assessment can be.

5.6 The Users of the Machinery

The intended users must also be considered.

Not every user has the same level of knowledge or experience.

There can be a significant difference between machinery intended exclusively for:

• trained professionals,

and machinery that may be operated by:

• less experienced operators,
• maintenance personnel,
• cleaning personnel,
• installers,
• or other persons.

The expected competence of users can therefore influence both the risk assessment and the required protective measures.

5.7 The Lifecycle of the Machinery

A machine is not only potentially hazardous during normal production.

The risk assessment should consider the relevant lifecycle phases.

These can include:

1. Transport
2. Assembly
3. Installation
4. Commissioning
5. Setup
6. Normal operation
7. Monitoring
8. Cleaning
9. Maintenance
10. Repair
11. Troubleshooting
12. Disassembly
13. Decommissioning
14. Disposal

The phases outside normal operation are often underestimated in practice.

5.8 Why Maintenance Is Particularly Important

Consider a machine where a moving component is completely enclosed by a guard during normal operation.

During maintenance, however, the guard has to be opened.

This creates a different situation:

• The person is closer to the hazard.
• The protective device may be open.
• The machine may need to remain energised.
• Controlled movement may be required.
• Stored energy may be present.

The risk assessment therefore cannot simply ask:

“Is the machine safe during normal operation?”

It must also ask:

“What happens when somebody has to maintain or troubleshoot this machine?”

5.9 Reasonably Foreseeable Misuse

The Machinery Directive requires manufacturers to consider not only the intended use of machinery.

They must also consider reasonably foreseeable misuse.

This does not mean that every imaginable misuse has to be considered.

It concerns misuse that may reasonably be expected as a result of readily predictable human behaviour.

Examples can include:

• removing an easily accessible guard,
• reaching into a machine to clear a blockage,
• using a tool in an obvious but unintended way,
• bypassing a protective device,
• entering an area that operators are not supposed to enter.

The specific assessment depends on the machinery and its environment.

5.10 “The Operator Is Not Allowed to Do That” Is Not Enough

One of the most common weaknesses in risk assessments is the statement:

“This action is prohibited in the operating instructions.”

That does not automatically eliminate the hazard.

If a behaviour is reasonably foreseeable and creates a significant risk, the manufacturer should consider whether additional technical protective measures are necessary.

A good risk assessment therefore considers not only ideal operation, but also realistic human behaviour.

5.11 Step 2 – Identify Hazards

Once the limits of the machinery have been determined, the next step is systematic hazard identification.

Different types of hazards should be considered.

These can include:

Mechanical hazards

• crushing,
• shearing,
• cutting,
• entanglement,
• drawing-in,
• impact,
• puncture,
• friction,
• abrasion,
• falling objects,
• ejected parts,
• loss of stability.

Electrical hazards

• electric shock,
• arc flash,
• short circuits,
• overheating,
• electrical energy,
• unexpected restart.

Thermal hazards

• hot surfaces,
• burns,
• scalding,
• fire,
• explosion,
• extreme cold.

Noise and vibration

• excessive noise,
• hand-arm vibration,
• whole-body vibration.

Radiation

• laser radiation,
• UV radiation,
• microwaves,
• ionising radiation,
• other optical or electromagnetic radiation.

Hazardous substances

• dust,
• gases,
• vapours,
• liquids,
• aerosols.

Ergonomic hazards

• awkward postures,
• repetitive movements,
• high operating forces,
• poor visibility,
• restricted access.

Control-system-related hazards

• unexpected start-up,
• unexpected movement,
• failure of safety-related control functions,
• loss of a safety function.

This list is not exhaustive.

The actual hazard identification must be tailored to the machinery.

5.12 Hazards Do Not Only Come From Individual Components

A risk assessment should not focus exclusively on individual components.

System interactions can also create hazards.

For example:

• two individually safe movements occurring simultaneously,
• a combination of software and mechanical functions,
• an interface between two machines,
• a sensor failure,
• or a particular operating mode

may create a dangerous situation.

The machinery therefore needs to be considered as a complete system.

5.13 Interfaces With Other Machinery

This is particularly important for production lines.

An individual machine may be safe when assessed independently.

Once it is connected to other machinery, however, additional hazards may arise.

Examples include:

• shared conveyor systems,
• shared controls,
• transfer points,
• common energy supplies,
• synchronised movements,
• common protective devices,
• or different emergency-stop concepts.

Where several machines form an integrated system, their interaction must therefore be considered.

5.14 Human-Machine Interaction

The interaction between people and machinery must also be assessed.

Questions can include:

• Where is the operator located?
• What movements can the operator make?
• Which areas can the operator reach?
• Which parts of the process are visible?
• Which parts are hidden?
• What information does the operator receive?
• What inputs can the operator provide?
• What happens after an incorrect input?
• What happens if the operator performs a task under time pressure?

For highly automated machinery, the human-machine interface can have a significant effect on risk.

5.15 Step 3 – Estimate the Risk

Once a hazard has been identified, the associated risk must be estimated.

At least two fundamental aspects need to be considered:

Severity of harm

How serious could the resulting injury or health damage be?

For example:

• minor injury,
• serious injury,
• permanent impairment,
• fatal injury.

Probability of occurrence

How likely is it that the hazardous situation will actually result in harm?

Relevant factors can include:

• frequency of exposure,
• duration of exposure,
• number of persons exposed,
• probability of a hazardous event,
• possibility of avoiding or limiting the harm.

5.16 Risk Estimation Is Not the Same as Risk Evaluation

These terms are often confused.

Risk estimation

This describes or determines the existing level of risk.

Risk evaluation

This determines whether the risk has been sufficiently reduced or whether additional measures are required.

In simplified form:

Estimation:

“How significant is the risk?”

Evaluation:

“Is this risk sufficiently controlled, or do we need further measures?”

This distinction is important for a consistent methodology.

5.17 Risk Matrices

Many organisations use a risk matrix.

Typically, the:

• severity of harm,
• and probability of occurrence

are combined.

A simplified example might look like this:

Severity	Low probability	Medium probability	High probability
Minor	Low	Low	Medium
Serious	Low	Medium	High
Severe	Medium	High	Very High

Such a matrix can be a useful practical tool.

However, it is important not to suggest that the Machinery Directive requires a specific risk matrix.

It does not.

The particular method used to estimate risk depends on the methodology adopted by the manufacturer.

EN ISO 12100 establishes the general principles of risk assessment but does not require every manufacturer to use the same numerical matrix.

5.18 Why Numbers Are Not Automatically Better

A risk assessment does not automatically become more rigorous simply because every risk receives a numerical score.

For example:

Probability = 3
Severity = 4
Risk = 12

Without defined criteria, this number tells an external reviewer very little.

Important questions remain:

• What does “3” mean?
• Why was “4” selected?
• What assumptions were made?
• What exposure was considered?
• Which protective measures are already in place?

A qualitative assessment with clear reasoning can be much more valuable than an apparently precise numerical assessment without a defensible methodology.

5.19 Step 4 – Evaluate the Risks

After estimating the risks, the manufacturer must determine whether the risks have been adequately reduced.

The evaluation should not simply state:

“Risk accepted.”

It should provide a meaningful basis for the decision.

Relevant considerations include:

• why the risk received its particular evaluation,
• which protective measures are already implemented,
• whether additional technical measures are reasonably possible,
• and whether the remaining risk is adequately controlled.

The manufacturer must consider the requirements of the Machinery Directive as well as the relevant state of the art.

5.20 Step 5 – Determine Protective Measures

Where risk reduction is necessary, the three-step method described earlier should be applied:

1. Inherently safe design measures

Eliminate or reduce the hazard through design.

2. Technical protective measures

Use guards and protective devices.

3. Information for users

Communicate remaining residual risks.

The risk assessment should make this hierarchy visible where appropriate.

5.21 Inherently Safe Design

The most effective protective measure is often a change to the design itself.

Examples include:

• reducing speed,
• reducing force,
• changing movement geometry,
• increasing safety distances,
• changing material selection,
• limiting stored energy,
• automating a hazardous process,
• eliminating sharp edges.

Where a hazard can reasonably be eliminated through design, that option should be considered first.

5.22 Technical Protective Measures

Where a hazard cannot be sufficiently eliminated through design, technical protective measures may be required.

Examples include:

• fixed guards,
• protective enclosures,
• interlocked doors,
• light curtains,
• laser scanners,
• two-hand controls,
• safe position monitoring,
• safe speed monitoring,
• emergency-stop functions,
• safety control systems.

The technical solution must correspond to the actual hazard.

5.23 User Information and Residual Risks

Even after technical protective measures have been implemented, some risks may remain.

For example, a machine may require the use of a sharp tool.

The manufacturer can:

• design the machine safely,
• prevent access to dangerous moving parts,
• and minimise exposure.

The sharp tool itself may nevertheless remain a source of injury.

The remaining risk therefore needs to be communicated appropriately.

The operating instructions must correspond to the results of the risk assessment.

5.24 Step 6 – Reassess the Risk After Protective Measures

A protective measure may reduce one risk while creating another.

For example:

A protective guard is installed.

This prevents access to a moving component.

However:

• visibility of the process may decrease,
• maintenance may become more difficult,
• the guard itself may create a crushing point,
• or operators may be tempted to remove the guard.

The manufacturer must therefore reassess the machinery after protective measures have been implemented.

The key question is:

Which risks remain, and have any new risks been introduced?

5.25 Step 7 – Determine Residual Risks

After all appropriate protective measures have been implemented, a residual risk may remain.

This should be explicitly documented.

For example:

“Following implementation of the fixed guard and monitored access control, no hazardous moving area is accessible during normal operation. A residual risk remains during tool replacement due to the sharp cutting edge.”

This makes it clear:

• what risk remains,
• when it occurs,
• and what precautions the user must take.

5.26 Residual Risk Does Not Automatically Mean Non-Compliance

The objective of risk assessment is not necessarily:

“Risk = zero.”

In practical engineering, not every risk can be completely eliminated.

The important point is that:

1. the hazard has been identified,
2. the risk has been assessed,
3. appropriate protective measures have been implemented,
4. remaining risks have been appropriately addressed,
5. and relevant residual risks are communicated to the user.

5.27 Protective Measures Must Be Verified

It is not enough to design a protective measure.

It must also be verified that it actually performs its intended function.

Examples include:

• Does the machine stop quickly enough?
• Is unexpected restart prevented?
• Does the sensor detect the intended condition?
• Does the interlock operate correctly?
• Does the safety function remain effective under relevant fault conditions?
• Is the required safety function actually achieved?

Depending on the protective measure, verification can involve:

• calculations,
• inspection,
• measurement,
• testing,
• functional testing,
• or validation.

5.28 Safety-Related Control Functions

Modern machinery frequently relies on control systems to perform safety functions.

For example:

Guard door opened

↓

Sensor detects condition

↓

Safety controller processes signal

↓

Drive receives safety command

↓

Hazardous movement stops

The manufacturer therefore cannot assess only the sensor.

The complete safety function must be considered:

Input → Logic → Output

The required reliability and performance of the safety function must be determined based on the actual risk.

Depending on the application, standards such as:

• EN ISO 13849-1
• EN IEC 62061

may be relevant.

The appropriate standard depends on the machine and its safety architecture.

5.29 Risk Assessment and Technical Documentation

The results of the risk assessment must feed into the technical documentation.

Machinery Directive 2006/42/EC requires the technical file to include, among other things, information concerning the protective measures implemented and, where appropriate, residual risks.

The risk assessment is therefore not separate from the technical file.

It is an important part of the technical evidence supporting conformity.

5.30 A Practical Risk Assessment Matrix

A practical risk assessment may use a structure such as:

Hazard	Situation	Risk	Protective measure	Residual risk	Evidence
Crushing	Access to moving axis	High	Interlocked guard door	Low	Functional test
Unexpected start	Power restoration	High	Restart inhibit	Low	Verification
Pneumatic energy	Maintenance	Medium	Pressure release	Low	Documentation
Sharp edge	Tool replacement	Medium	Guard / protective procedure	Low	Inspection
Noise	Normal operation	Medium	Noise reduction measures	Medium	Measurement
Electric shock	Maintenance	High	Protection against direct contact	Low	Electrical test

The actual values and protective measures must, of course, be determined specifically for the machinery being assessed.

5.31 Risk Assessment Should Be Traceable

A good risk assessment should be understandable to a third party.

An engineer, reviewer or competent authority should be able to determine:

• which machine was assessed,
• which limits were established,
• which hazards were identified,
• how risks were evaluated,
• which protective measures were selected,
• which residual risks remain,
• and how compliance is demonstrated.

A clear traceability structure is therefore extremely valuable.

5.32 Link Requirements to Evidence

A strong compliance approach connects each relevant requirement to evidence.

For example:

Annex I requirement

↓

Identified hazard

↓

Protective measure

↓

Verification method

↓

Evidence

This makes it possible to demonstrate not merely that a requirement was considered, but how compliance was achieved.

5.33 Common Mistake: Creating the Risk Assessment Too Late

One of the most common mistakes is to complete the machine first and create the risk assessment afterwards.

This effectively turns the risk assessment into a documentation exercise.

A better approach is to involve risk assessment during:

• concept development,
• mechanical design,
• electrical design,
• control-system design,
• prototype development,
• testing,
• and final validation.

This allows hazards to be eliminated before they become expensive design problems.

5.34 Common Mistake: Copying an Existing Risk Assessment

Another common problem is copying the risk assessment from an earlier machine.

This can be problematic if:

• the design has changed,
• operating conditions are different,
• new components are used,
• different interfaces exist,
• new software has been introduced,
• or the intended use has changed.

An earlier risk assessment can be a useful starting point.

It cannot replace an assessment of the actual machine.

5.35 Common Mistake: Assessing Only Normal Operation

A machine may be perfectly controlled during automatic operation but become significantly more hazardous during:

• setup,
• cleaning,
• maintenance,
• troubleshooting,
• tool replacement,
• or manual intervention.

These operating situations therefore need to be considered explicitly.

5.36 Common Mistake: Treating Warnings as the Primary Solution

A warning label is often the easiest measure to add.

That does not make it the best measure.

For example:

“Danger – moving parts. Keep hands away.”

may communicate a hazard, but it does not physically prevent access.

Where the hazard can reasonably be reduced through:

• design,
• guarding,
• interlocking,
• or another technical measure,

that approach should be considered before relying on warnings.

5.37 Common Mistake: Ignoring Software

In modern machinery, safety functions may depend heavily on software.

Examples include:

• safe speed limitation,
• safe position monitoring,
• safe torque removal,
• guard monitoring,
• process monitoring.

A software or parameterisation error can therefore affect a safety function.

The risk assessment must take into account which safety functions depend on control-system and software functions.

5.38 Common Mistake: Changes After Completion

A particularly practical problem occurs when the machine is modified after the risk assessment has been completed.

For example:

• a motor is replaced,
• operating speed is increased,
• a tool is changed,
• a guard is moved,
• software is modified,
• a new operating mode is introduced.

The manufacturer should then ask:

Does this change affect the risk assessment?

If it does, the assessment and associated technical documentation need to be updated.

5.39 Risk Assessment Is an Engineering Process

A meaningful machinery risk assessment often requires input from several disciplines:

• mechanical engineering,
• electrical engineering,
• control systems,
• software,
• ergonomics,
• production,
• maintenance,
• occupational safety,
• and regulatory compliance.

For complex machinery, it should therefore not be treated as an isolated administrative task performed without sufficient knowledge of the actual machine.

5.40 The Role of EN ISO 12100

EN ISO 12100 – Safety of machinery – General principles for design – Risk assessment and risk reduction is one of the most important standards for the general methodology of machinery risk assessment.

It addresses areas including:

• fundamental terminology,
• principles of risk assessment,
• hazard identification,
• risk estimation,
• risk evaluation,
• and risk reduction.

It is therefore a key technical tool for machinery manufacturers.

However, its role needs to be understood correctly:

EN ISO 12100 is not the Machinery Directive.

The legal obligations arise from the applicable legislation.

The standard provides a technical methodology that manufacturers can use to systematically address those obligations.

5.41 A Practical Workflow for Manufacturers

A professional workflow can be structured as follows.

Phase 1 – Product Definition

• Describe the machine
• Define its limits
• Define intended use
• Identify users
• Define operating modes

Phase 2 – Hazard Analysis

• Examine lifecycle phases
• Identify hazards
• Analyse interfaces
• Consider foreseeable misuse

Phase 3 – Risk Evaluation

• Estimate risks
• Evaluate risks
• Determine the need for action

Phase 4 – Risk Reduction

• Improve the design
• Define protective measures
• Design safety-related control functions
• Define warnings and information

Phase 5 – Verification

• Verify protective measures
• Validate safety functions
• Perform measurements
• Perform tests

Phase 6 – Completion

• Document residual risks
• Prepare instructions
• Complete the technical documentation
• Perform the conformity assessment

5.42 What Makes a Good Risk Assessment?

A good risk assessment is:

Systematic

It follows a defined and understandable methodology.

Machine-specific

It describes the actual machine rather than a generic product.

Traceable

Decisions and evaluations can be explained.

Technically connected

Risks are linked to concrete protective measures.

Current

Changes to the machinery are reflected.

Comprehensive

Relevant lifecycle phases and foreseeable misuse are considered.

Verifiable

The effectiveness of protective measures can be demonstrated.

5.43 The Central Relationship

The entire machinery compliance process can be viewed as a chain:

Machine

↓

Hazards

↓

Risks

↓

Requirements

↓

Protective measures

↓

Standards / technical solutions

↓

Testing and validation

↓

Technical documentation

↓

Declaration of Conformity

When this chain is traceable, the manufacturer has a much stronger basis for demonstrating conformity.

5.44 What a Risk Assessment Is Not

A risk assessment is not:

• merely a list of standards,
• a checklist without technical reasoning,
• a collection of warning labels,
• a document created only after the machine is finished,
• a generic statement that “all risks are acceptable,”
• or a copy of the risk assessment from another machine.

It is the systematic technical assessment of the risks associated with a specific machine and the protective measures derived from that assessment.

5.45 From Risk Assessment to Standards

Once the risk assessment has been completed, the next major question is:

Which standards should be applied to the specific machine?

This is an area where manufacturers frequently encounter confusion.

There are:

• Type-A standards,
• Type-B standards,
• Type-C standards,
• harmonised standards,
• non-harmonised standards,
• product-specific standards,
• safety standards,
• and standards covering specific technical functions.

Not every standard is automatically relevant.

And applying a relevant standard does not automatically mean that the entire machine is compliant.

The selection of standards must therefore be derived from:

• the machinery,
• the identified hazards,
• the applicable legal requirements,
• and the technical solutions used to reduce risk.

This will be examined in detail in the next chapter.

Official Sources

• EUR-Lex – Machinery Directive 2006/42/EC — particularly Article 5, Article 12 and Annex I.
• European Commission – Machinery — official information on the Machinery Directive and related guidance.
• European Commission – Harmonised Standards for Machinery — official information on harmonised standards for machinery.
• EN ISO 12100 – Safety of machinery – General principles for design – Risk assessment and risk reduction — the principal technical standard for the methodology of machinery risk assessment and risk reduction.

6. Harmonised Standards and Their Role in Machinery Compliance

Once the manufacturer has identified the hazards and applicable essential health and safety requirements, the next question is:

Which standards should be used to design, assess and demonstrate compliance with the machinery?

This is one of the most misunderstood areas of machinery compliance.

A manufacturer may have dozens or even hundreds of standards available that appear relevant to its product. However, not every standard needs to be applied, and not every standard has the same legal significance.

A particularly important distinction is between:

• legislation,
• harmonised European standards,
• non-harmonised standards,
• international standards,
• and company-specific technical specifications.

Understanding this hierarchy is essential for a robust CE compliance strategy.

6.1 What Is a Standard?

A standard is a technical document that establishes agreed technical rules, specifications, methods or criteria.

Standards can address subjects such as:

• machine design,
• electrical safety,
• mechanical safety,
• control systems,
• ergonomics,
• noise,
• electromagnetic compatibility,
• functional safety,
• guards,
• emergency-stop functions,
• safety distances,
• specific machine types,
• and testing methods.

Standards are developed by recognised standardisation organisations.

At European level, important organisations include:

• CEN – European Committee for Standardization
• CENELEC – European Committee for Electrotechnical Standardization
• ETSI – European Telecommunications Standards Institute

For machinery, CEN and CENELEC are particularly important.

6.2 A Standard Is Not the Law

This distinction is fundamental.

A standard is generally not legislation.

The legal obligations come from the applicable legislation, such as:

Directive 2006/42/EC – Machinery Directive

A standard provides a technical way of addressing particular requirements.

This means that:

Compliance with a standard and compliance with legislation are related, but they are not identical concepts.

A machine does not become compliant simply because the manufacturer has written several standards into its technical file.

The manufacturer must first determine the applicable legal requirements and then demonstrate that those requirements have been fulfilled.

6.3 What Is a Harmonised Standard?

A harmonised standard is a European standard developed by a European Standardisation Organisation following a request from the European Commission and referenced through the EU’s official framework.

For machinery, harmonised standards can provide a recognised technical route for addressing relevant requirements of the Machinery Directive.

The European Commission publishes information on harmonised standards for machinery, including references and applicable legal frameworks.

6.4 Why Harmonised Standards Matter

The major advantage of using an applicable harmonised standard is the possibility of benefiting from a presumption of conformity for the requirements covered by that standard.

This is extremely important.

It means that, when the relevant conditions are fulfilled, the manufacturer has a recognised technical basis for demonstrating conformity with the corresponding essential health and safety requirements.

However:

Presumption of conformity is not the same as automatic compliance.

The manufacturer still has to:

• apply the standard correctly,
• ensure that it actually applies to the machinery,
• identify which requirements are covered,
• fulfil the relevant provisions,
• and complete the overall conformity assessment.

6.5 Presumption of Conformity

The concept can be simplified as follows:

Applicable legislation

↓

Relevant harmonised standard

↓

Correct application

↓

Requirements addressed

↓

Presumption of conformity for those requirements

The important qualification is:

for those requirements covered by the standard.

A standard may address only part of the requirements applicable to a machine.

For example, a standard may address:

• mechanical hazards,

while not addressing:

• electrical hazards,
• EMC,
• noise,
• software,
• or another specific hazard.

The manufacturer therefore cannot assume that applying one standard makes the complete machine compliant.

6.6 Harmonised Standards Are Not Mandatory in the Same Way as Legislation

This is another area where manufacturers often use incorrect wording.

A harmonised standard itself generally does not create a legal obligation equivalent to an EU directive or regulation.

A manufacturer can potentially use other technical solutions to demonstrate that the applicable legal requirements have been fulfilled.

However, choosing not to use an applicable harmonised standard can make the conformity assessment more difficult because the manufacturer may no longer be able to rely on the associated presumption of conformity.

Therefore:

“Not mandatory” does not mean “irrelevant.”

Harmonised standards are often the most efficient and technically recognised route to demonstrate compliance.

6.7 The Difference Between “Harmonised” and “European”

These terms should not be treated as synonyms.

A European standard may be published by CEN or CENELEC.

But a European standard is not automatically a harmonised standard under a specific EU legislation.

For regulatory purposes, the manufacturer must determine whether the standard has the relevant status under the legislation being applied.

This distinction is particularly important when preparing a Declaration of Conformity.

6.8 The Official Standard Reference Matters

Manufacturers should avoid relying solely on a standard title.

A standard reference normally contains information such as:

EN ISO 12100:2010

The:

• standard number,
• year/version,
• amendment status,
• and applicable legal framework

can matter.

Using an outdated edition without checking its current status can create unnecessary compliance problems.

6.9 The Machinery Standards Hierarchy

Machinery standards are commonly divided into three broad categories:

Type-A standards

Type-B standards

Type-C standards

This classification is particularly useful because it helps manufacturers understand the relationship between general machinery safety principles and machine-specific requirements.

6.10 Type-A Standards

Type-A standards deal with basic concepts, terminology, principles and general aspects applicable to machinery.

The most important example is:

EN ISO 12100

It establishes general principles for:

• risk assessment,
• risk reduction,
• terminology,
• design principles,
• and protective measures.

Type-A standards provide the foundation for the overall machinery safety approach.

6.11 Type-B Standards

Type-B standards address particular safety aspects or types of safety devices that can be used across many different types of machinery.

They are generally divided into:

Type-B1

Standards covering particular safety aspects.

Examples include areas such as:

• safety distances,
• ergonomic principles,
• noise,
• vibration,
• temperature,
• pressure.

Type-B2

Standards covering safety devices.

Examples can include:

• two-hand controls,
• emergency-stop functions,
• protective devices,
• interlocking devices,
• sensitive protective equipment.

These standards can be relevant to a wide range of machines.

6.12 Type-C Standards

Type-C standards are machine-specific safety standards.

They address the safety requirements for a particular machine or group of machines.

For example, there may be Type-C standards for:

• presses,
• packaging machinery,
• woodworking machinery,
• robots,
• injection moulding machines,
• machine tools,
• lifting equipment,
• or other specialised machinery.

When an applicable Type-C standard exists, it can be particularly valuable because it addresses the hazards and safety measures associated with that specific type of machinery.

6.13 Why the Hierarchy Matters

Consider a manufacturer producing a packaging machine.

The manufacturer might use:

• EN ISO 12100 for the general risk assessment methodology,
• relevant Type-B standards for guards and safety distances,
• standards for safety-related control systems,
• and a relevant Type-C standard for the specific packaging machine.

The standards therefore complement one another.

They are not necessarily alternatives.

6.14 Type-C Standards Can Change the Approach

There is an important principle in the machinery standards hierarchy.

Where a Type-C standard provides requirements that differ from general requirements in a Type-A or Type-B standard, the Type-C standard can take precedence for the specific machinery within its scope.

This is because the Type-C standard has been developed specifically around the hazards and safety requirements of that particular machine category.

Manufacturers should therefore always check whether a relevant Type-C standard exists before relying solely on generic machinery standards.

6.15 Standards Must Be Selected Based on the Actual Machine

A common mistake is to create a generic list such as:

• EN ISO 12100
• EN ISO 13849-1
• EN 60204-1
• EN ISO 13850
• EN ISO 14120
• EN ISO 14119

and assume that the machine is now covered.

This is not a proper standards assessment.

The manufacturer should instead work backwards from:

Machine

↓

Hazards

↓

Applicable legal requirements

↓

Relevant standards

This ensures that standards are selected because they address actual risks and requirements.

6.16 Standards Should Not Be Selected by Product Name Alone

Two machines with the same commercial product name can have completely different safety architectures.

For example, two machines might both be called:

“Automatic Assembly Machine”

but one may have:

• pneumatic movement,
• manual loading,
• enclosed tooling,
• no robot,

while the other has:

• servo-driven axes,
• robotic handling,
• automated material loading,
• vision systems,
• and multiple operating modes.

Their applicable standards can therefore be significantly different.

6.17 Start With the Applicable Legislation

Before selecting standards, the manufacturer should determine which legislation applies.

For machinery placed on the EU market, this may include the Machinery Directive during its applicable transition period, while other legislation may also apply depending on the machine and its characteristics.

Potentially relevant legislation can include:

• Machinery legislation,
• EMC legislation,
• Low Voltage legislation where applicable,
• Pressure Equipment legislation,
• ATEX legislation,
• Radio Equipment legislation,
• RoHS,
• or other product-specific legislation.

The exact combination depends on the product.

This is why regulatory scoping should come before standards selection.

6.18 One Machine Can Be Subject to Multiple EU Acts

A machine can incorporate different technologies.

For example, an industrial machine might contain:

• electrical equipment,
• radio modules,
• pressure systems,
• lasers,
• software,
• and hazardous substances.

Different EU legislation can therefore apply simultaneously.

The manufacturer needs to establish the complete regulatory scope rather than assuming:

“It is a machine, therefore only the Machinery Directive applies.”

6.19 Machinery With Radio Functions

This becomes particularly important for connected machinery.

A machine may contain:

• Wi-Fi,
• Bluetooth,
• cellular communication,
• proprietary radio,
• or other wireless functions.

Depending on the product architecture and applicable legal framework, radio functionality can introduce additional regulatory requirements.

The manufacturer must therefore determine whether the radio equipment requirements apply to the final product and how the radio module and host product interact.

A pre-certified radio module does not automatically mean that the complete machine is compliant.

6.20 Standards Do Not Replace Risk Assessment

Another major misconception is:

“We use the correct standards, so we don’t need a detailed risk assessment.”

The opposite is closer to reality.

The risk assessment is what helps the manufacturer determine:

• which hazards exist,
• which requirements are relevant,
• which standards are applicable,
• and which protective measures are required.

Standards provide technical solutions.

The risk assessment determines why those solutions are needed.

6.21 A Standard Cannot Make a Known Hazard Disappear

Suppose a machine has a crushing hazard.

The manufacturer cannot simply write:

EN ISO 12100 applied.

The actual hazard still needs to be:

• identified,
• assessed,
• reduced,
• and verified.

The standard provides the methodology and technical principles.

It does not perform the engineering work for the manufacturer.

6.22 Applying a Standard Incorrectly

Another important issue is incorrect application.

A standard may contain:

• mandatory requirements,
• recommendations,
• notes,
• informative annexes,
• calculation methods,
• test procedures,
• design requirements,
• and specific conditions of application.

The manufacturer must understand what applies to the particular machine.

Simply claiming:

“Standard applied”

without evidence is weak technical documentation.

6.23 Standards and the State of the Art

Machinery safety does not exist in a static environment.

Technology develops.

New:

• sensors,
• control systems,
• robotics,
• software,
• drive systems,
• safety devices,
• and manufacturing processes

can change what constitutes technically appropriate risk reduction.

The manufacturer should therefore consider the relevant state of the art when designing and assessing the machine.

This does not mean that the newest technology must automatically be used.

It means that the manufacturer cannot simply ignore established technical developments when determining appropriate protective measures.

6.24 Standards Are Not a Substitute for Engineering Judgment

A machine can comply with the technical provisions of several standards and still require additional engineering consideration.

For example, the manufacturer may identify a hazard that is:

• unusual,
• caused by a special operating mode,
• related to a unique machine configuration,
• or not adequately addressed by an existing standard.

The manufacturer must still address that hazard.

The absence of a specific standard does not mean the hazard can be ignored.

6.25 What If No Specific Standard Exists?

This is a common situation, particularly for innovative machinery.

The manufacturer can use:

• general machinery standards,
• relevant Type-B standards,
• applicable safety standards,
• recognised engineering principles,
• technical calculations,
• testing,
• validation,
• and other appropriate evidence.

The fundamental legal requirements remain the starting point.

A machine does not become exempt from safety requirements simply because there is no dedicated Type-C standard.

6.26 What If a Standard Is Not Harmonised?

A non-harmonised standard can still be technically useful.

It may provide:

• recognised engineering principles,
• test methods,
• design requirements,
• safety concepts,
• or useful technical benchmarks.

However, the legal significance differs from an applicable harmonised standard.

The manufacturer should therefore distinguish clearly between:

Technical use of a standard

and

Regulatory presumption of conformity.

6.27 The Harmonised Standard List Must Be Checked

Manufacturers should not assume that a standard is harmonised simply because:

• it starts with “EN”,
• it is published by CEN/CENELEC,
• it appears on a commercial standards website,
• or another manufacturer uses it.

The official status needs to be checked against the applicable EU framework.

For machinery, the European Commission provides the relevant information on harmonised standards and references.

6.28 The Standard Edition Matters

Suppose a manufacturer has used:

EN XXXX:2015

but a newer edition exists.

The manufacturer should determine:

• whether the old edition remains relevant,
• whether it has been superseded,
• whether it remains listed for the relevant legislation,
• whether a transition period applies,
• and whether the newer edition introduces technical changes relevant to the machine.

Simply seeing a newer edition does not by itself answer all of these questions.

The regulatory status must be checked.

6.29 Standards Can Have Different Regulatory Statuses

For compliance work, it is useful to distinguish at least:

Status	Meaning
Harmonised standard	Can provide presumption of conformity for covered requirements when correctly applied
European standard	European technical standard, but not necessarily harmonised for the relevant legislation
International standard	Developed internationally; may be technically useful but does not automatically provide EU presumption
National standard	National technical standard
Company specification	Internal engineering requirement

This distinction should be reflected in the technical documentation.

6.30 The Declaration of Conformity

The standards used for the conformity assessment are normally reflected in the EU Declaration of Conformity where applicable.

However, the Declaration of Conformity should not simply become a long list of every document the manufacturer has ever consulted.

The listed standards should correspond to the standards actually used as part of the conformity assessment.

The manufacturer should be able to explain the relationship between each listed standard and the machine.

6.31 Common Mistake: “More Standards = More Compliance”

This is a surprisingly common misconception.

A manufacturer may list twenty or thirty standards in an attempt to demonstrate that the machine has been thoroughly assessed.

This can actually create problems.

If the manufacturer claims to have applied a standard, it should be able to demonstrate that the relevant requirements were actually considered.

A long list is therefore not automatically a strong list.

The objective is not to apply as many standards as possible. The objective is to apply the right standards for the actual machine.

6.32 Common Mistake: Copying the Standards From a Competitor

A competitor’s Declaration of Conformity can sometimes be useful for market research.

It should not be treated as the manufacturer’s own standards assessment.

The competitor may have:

• a different machine configuration,
• different components,
• different operating conditions,
• different safety architecture,
• different legislation,
• or a different intended use.

The applicable standards must therefore be independently determined.

6.33 Common Mistake: Using an Outdated Standard Without Checking

Another frequent problem is:

“We have always used this standard.”

Regulatory and standards landscapes evolve.

A standard may:

• be revised,
• be replaced,
• lose its harmonised status,
• acquire a transition period,
• or be affected by changes in legislation.

For a professional compliance process, the current regulatory status should therefore be checked rather than relying on historical practice.

6.34 Common Mistake: Treating a Standard Certificate as Proof of Complete Compliance

A supplier may provide a certificate stating that a component complies with a particular standard.

That can be valuable evidence.

But it does not automatically prove that the complete machine complies.

The manufacturer remains responsible for the integration of:

• components,
• control systems,
• protective devices,
• software,
• mechanical systems,
• and interfaces.

A safe component can become part of an unsafe system if it is incorrectly integrated.

6.35 Component Compliance vs. Machine Compliance

This distinction is especially important.

Consider a safety sensor that complies with its applicable product standard.

The final machine still needs to demonstrate that:

• the sensor is correctly installed,
• the sensing distance is appropriate,
• the safety circuit is correctly designed,
• the controller processes the signal correctly,
• the final actuator achieves the required safety function,
• and the overall safety function performs as required.

Therefore:

Component compliance is evidence. It is not a substitute for system-level assessment.

6.36 Standards and Testing

Some standards contain specific test requirements.

Depending on the machine, testing can involve:

• electrical tests,
• insulation tests,
• protective-earth continuity,
• temperature measurements,
• noise measurements,
• vibration measurements,
• stopping-time measurements,
• safety-function testing,
• EMC testing,
• mechanical strength testing,
• or functional tests.

The applicable tests should be derived from the requirements and standards relevant to the machine.

6.37 Standards and Technical Documentation

The technical documentation should allow the manufacturer to demonstrate:

Requirement

→

Hazard

→

Standard

→

Technical implementation

→

Verification

→

Evidence

This is much stronger than simply maintaining a folder containing copies of standards.

6.38 A Practical Standards Assessment

A useful internal standards matrix could look like this:

Requirement / Hazard	Applicable Standard	Status	Relevant Clauses	Implementation	Evidence
General risk reduction	EN ISO 12100	Harmonised*	Relevant clauses	Risk assessment	Risk assessment
Safety-related control functions	EN ISO 13849-1	Harmonised*	Relevant clauses	Safety PLC	Calculation / validation
Electrical equipment	EN 60204-1	Harmonised*	Relevant clauses	Electrical design	Test report
Guards	EN ISO 14120	Harmonised*	Relevant clauses	Fixed guards	Inspection
Interlocking	EN ISO 14119	Harmonised*	Relevant clauses	Interlock system	Functional test

*The exact harmonisation status must be verified for the applicable legislation and date.

This structure makes the standards assessment much more transparent.

6.39 The Importance of the Date

Standards compliance is not completely independent of time.

A conformity assessment performed in:

2026

may not necessarily use exactly the same regulatory framework as one performed in:

2029.

This is particularly relevant because the EU machinery framework is transitioning from the Machinery Directive 2006/42/EC to the Machinery Regulation (EU) 2023/1230.

Manufacturers must therefore consider not only:

“Which standard applies?”

but also:

“Which legal framework applies at the time the product is placed on the market?”

6.40 The Machinery Regulation

The Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive.

It introduces a new legal framework for machinery products and becomes the central EU machinery legislation from its applicable date.

This transition is particularly important for manufacturers developing products today because machinery projects can have development cycles lasting several years.

The manufacturer should therefore establish the applicable legislation based on:

• product type,
• date of placing on the market,
• transitional provisions,
• and the specific circumstances of the product.

This subject deserves separate treatment and will be examined later in this guide.

6.41 A Practical Decision Tree

A useful approach for standards selection is:

Question 1

What legislation applies?

↓

Question 2

What machinery category is involved?

↓

Question 3

What hazards were identified?

↓

Question 4

Is there an applicable Type-C standard?

↓

Question 5

Which Type-B standards address the identified hazards?

↓

Question 6

Which Type-A standards provide the general methodology?

↓

Question 7

Are additional standards required for electrical, EMC, radio, pressure, ATEX or other technologies?

↓

Question 8

What evidence demonstrates compliance with each applicable requirement?

This approach is much more robust than starting with a generic list of standards.

6.42 Standards Should Be Mapped to Requirements

For a professional compliance process, it is useful to create a requirements-to-standards matrix.

For example:

Essential Requirement	Hazard / Topic	Standard	Covered?	Evidence
Protection against mechanical hazards	Crushing	EN ISO 12100 / applicable C-standard	Yes	Design + inspection
Guards	Access to moving parts	EN ISO 14120	Yes	Guard inspection
Interlocking	Guard access	EN ISO 14119	Yes	Functional test
Safety-related controls	Unexpected movement	EN ISO 13849-1	Yes	PL calculation + validation
Electrical equipment	Electric shock	EN 60204-1	Yes	Electrical test

This provides a clear traceability chain.

6.43 The Most Important Principle

Standards should not drive the risk assessment.

The process should work in the opposite direction:

The risk assessment drives the selection of standards.

The manufacturer first determines:

What can go wrong?

Then:

What legal requirement applies?

Then:

Which standard provides an appropriate technical solution?

This approach prevents the compliance process from becoming a simple checklist exercise.

6.44 Summary

Harmonised standards are one of the most important tools available to machinery manufacturers.

They can provide:

• recognised technical solutions,
• structured design requirements,
• test methods,
• and, where applicable, a presumption of conformity for the requirements covered by the standard.

However, standards should always be used within the broader compliance framework.

A robust process is:

Determine legislation

↓

Perform risk assessment

↓

Identify applicable requirements

↓

Select relevant standards

↓

Implement technical solutions

↓

Verify and validate

↓

Document evidence

The manufacturer should therefore never ask only:

“Which standards apply to my machine?”

A better question is:

“Which legal requirements apply to my machine, which hazards create those requirements, which standards provide suitable technical solutions, and how can I demonstrate that those solutions have been correctly implemented?”

That distinction is at the heart of a professional machinery compliance process.

Official Sources

• EUR-Lex – Directive 2006/42/EC on machinery
• European Commission – Machinery
• European Commission – Harmonised standards for machinery
• EUR-Lex – Regulation (EU) 2023/1230 on machinery products
• EN ISO 12100 – Safety of machinery – General principles for design – Risk assessment and risk reduction.
• EN ISO 13849-1 – Safety of machinery – Safety-related parts of control systems.
• EN IEC 62061 – Safety of machinery – Functional safety of safety-related control systems.
• EN ISO 14119 – Safety of machinery – Interlocking devices associated with guards.
• EN ISO 14120 – Safety of machinery – Guards – General requirements for the design and construction of fixed and movable guards.

7. Pre-Compliance – Identifying Problems Before They Become Expensive

The formal conformity assessment of a machine should not be the point at which the manufacturer discovers for the first time whether the machine is actually safe and compliant.

If a problem is discovered only at the end of the development process, correcting it can have significant consequences:

• Design changes
• Changes to guards or protective devices
• Changes to control systems
• Software modifications
• Additional testing
• Repetition of tests that have already been completed
• Delays in delivery
• Additional costs
• Or, in the worst case, fundamental changes to the machine

This is where pre-compliance becomes valuable.

Pre-compliance does not mean that the manufacturer has already completed the formal conformity assessment. Instead, it is an approach for identifying potential safety and compliance problems as early as possible in the development process and correcting them before they become expensive or difficult to resolve.

This is particularly important for complex machinery because many safety-related characteristics are determined by fundamental design decisions made early in development.

7.1 Why Is Pre-Compliance Necessary?

The Machinery Directive requires the manufacturer, among other things, to carry out a risk assessment and the necessary investigations and tests to determine whether the machine, by its design and construction, can be assembled and put into service safely. The results must form part of the technical documentation.

This reflects an important principle:

Safety and compliance need to be considered during machine development—not only after the machine has been completed.

A machine should therefore not be developed according to the following approach:

Build the machine → test it at the end → discover problems → modify the machine

A much better approach is:

Determine requirements → identify risks → develop the safety concept → verify early → complete the machine → perform final validation

7.2 Pre-Compliance Is Not a Separate Legal Conformity Procedure

The term pre-compliance primarily describes a practical development and testing approach.

It is not itself a formal conformity assessment procedure defined by the Machinery Directive.

Therefore:

A pre-compliance test does not replace the risk assessment or the legally required conformity assessment.

Instead, pre-compliance is a tool for increasing the likelihood that the final conformity assessment will be successful.

7.3 Pre-Compliance vs. Final Compliance

The two concepts should be clearly distinguished.

Pre-Compliance

Objective:

Identify and eliminate problems early.

Typical activities include:

• Technical design reviews
• Safety concept reviews
• Risk assessment
• Preliminary measurements
• Functional tests
• Safety-function tests
• EMC pre-compliance testing
• Electrical safety checks
• Noise measurements
• Inspection of protective devices
• Software and control-system reviews

Final Compliance

Objective:

Demonstrate conformity of the finished machine.

Depending on the machine, this can include:

• Complete risk assessment
• Technical documentation
• Required testing
• Conformity assessment
• Operating instructions
• Declaration of Conformity
• CE marking
• And, where applicable, involvement of a notified body

The exact procedure depends on the machine and the applicable conformity assessment route.

7.4 Why Early Testing Can Be Much Less Expensive

A problem identified during an early development phase can often be corrected relatively easily.

For example, a risk assessment may identify that a particular access point to a moving machine component is insufficiently protected.

While the machine is still being designed, the manufacturer may be able to:

• Change the geometry
• Add a guard
• Integrate a protective door
• Add a sensor
• Or redesign the hazardous area

Once the machine has been fully constructed and integrated into a production line, the same change may be considerably more complicated.

It may require:

• Mechanical modifications
• New cable routing
• Control-system changes
• Safety software modifications
• Revalidation of safety functions
• Repetition of testing
• Or even retrofitting machines that have already been delivered

7.5 Design for Compliance

A professional approach is therefore to consider compliance directly during machine design.

This can be described as:

Design for Compliance

The manufacturer does not first design a machine and then attempt to make it compliant afterward.

Instead, the development process incorporates:

• Legal requirements
• Risk assessment
• Safety requirements
• Applicable standards
• Testing requirements
• Operating conditions
• Intended use
• Reasonably foreseeable misuse
• And technical documentation

Compliance therefore becomes part of product development itself.

7.6 When Should Pre-Compliance Take Place?

Pre-compliance should not be treated as a single activity shortly before development is completed.

A better approach is a phased assessment.

Phase 1 – Concept

Already during the concept phase, the manufacturer should consider:

• What machine is being developed?
• What is its intended use?
• What operating modes will exist?
• Which people may interact with it?
• What hazards can already be anticipated?
• Which legal requirements are relevant?
• Which standards may be relevant?

Phase 2 – Design

During design, the protective measures become more concrete.

The manufacturer should review, among other things:

• Guards
• Safety distances
• Access points
• Movements
• Drives
• Control systems
• Emergency stop
• Interlocking
• Operating modes
• Safety functions
• Electrical equipment

Phase 3 – Prototype

The prototype provides an important opportunity to verify technical assumptions.

Depending on the machine, the manufacturer may investigate:

• Safety functions
• Stop times
• Machine movements
• Temperatures
• Electrical characteristics
• Noise
• EMC behavior
• Mechanical protective measures

Phase 4 – Pre-Series Machine

With a pre-series machine, the assessment should be much closer to the final product.

The manufacturer should verify in particular:

• Whether the planned protective measures actually work
• Whether the documentation corresponds to the real machine
• Whether development changes have been incorporated
• Whether significant compliance issues remain open

Phase 5 – Series Production

Before releasing a machine for series production, the manufacturer should ensure that the production version remains consistent with the machine that was assessed.

This is particularly important for series-produced machinery.

The Machinery Directive requires appropriate internal measures for series production to ensure that manufactured machines continue to conform to the relevant requirements and technical documentation.

7.7 Pre-Compliance Starts with the Risk Assessment

One of the most important pre-compliance activities is the risk assessment.

The Machinery Directive requires manufacturers to carry out a risk assessment in order to determine the applicable safety and health protection requirements for the machine.

The assessment should not be limited to obvious hazards.

Depending on the machine, relevant hazards can include:

• Mechanical movement
• Crushing
• Shearing
• Cutting
• Entanglement
• Impact
• Ejection of parts
• Electrical hazards
• Hot surfaces
• Noise
• Vibration
• Radiation
• Pressure
• Unexpected movement
• Malfunctions
• Maintenance activities
• Cleaning
• Setup
• Transport
• Dismantling
• And reasonably foreseeable misuse

7.8 Do Not Consider Only Normal Operation

A common mistake is to assess the machine only during normal production.

A machine can be safe during normal operation and still create significant hazards during:

• Cleaning
• Maintenance
• Setup
• Troubleshooting
• Tool changes
• Format changes
• Diagnostics
• Manual operation
• Test operation
• Or dismantling

Pre-compliance should therefore consider all relevant operating and lifecycle phases.

7.9 Operating Modes Are Particularly Important

Modern machines often have several operating modes, such as:

• Automatic
• Manual
• Setup
• Service
• Maintenance
• Test

Each operating mode can create different risks.

A protective measure that is sufficient in automatic operation may not be sufficient during setup.

Every relevant operating mode should therefore be included in the safety assessment.

7.10 Test Safety Functions Early

Safety functions should not be tested only at the end.

Examples include:

• Emergency stop
• Guard-door monitoring
• Light curtains
• Two-hand controls
• Safe speed
• Safe motion limitation
• Safe shutdown
• Interlocking
• Drive monitoring

Simply confirming:

“The machine stops.”

may not be sufficient.

Depending on the safety function, it may also be necessary to determine:

• How quickly does the machine stop?
• Is the remaining motion acceptable?
• Is the hazardous energy actually controlled?
• Can the machine restart unexpectedly?
• Does the safety function work in all relevant operating modes?
• What happens if a fault occurs within the safety system?

7.11 Stop Time Is Not the Same as “Machine Off”

For many machines, a critical question is:

How long does a hazardous machine component continue moving after the protective function has been triggered?

A motor may be switched off immediately, while mechanical movement continues because of:

• Inertia
• Flywheel effects
• Stored energy
• Pressure
• Spring forces
• Or other forms of stored energy

The safety assessment therefore needs to consider the machine’s actual physical behavior.

7.12 EMC Pre-Compliance

For machines containing electrical and electronic components, EMC pre-compliance testing can also be useful.

The objective is not necessarily to perform the complete formal EMC assessment early, but to identify potential problems before final testing.

Pre-compliance investigations can reveal issues involving:

• Electromagnetic emissions
• Immunity
• Cable routing
• Grounding
• Shielding
• Or problematic circuit layouts

If a problem is discovered only during final EMC testing, troubleshooting and corrective action can become considerably more difficult.

7.13 Electrical Pre-Compliance

Electrical safety can also be investigated before the final assessment.

Depending on the machine, relevant topics can include:

• Protective conductors
• Insulation
• Protection against electric shock
• Dielectric strength
• Leakage currents
• Markings
• Control cabinet construction
• Cable routing
• Protection against unexpected restart
• Isolation of energy sources

The exact tests should be derived from the requirements and standards applicable to the particular machine.

7.14 Mechanical Pre-Compliance

Mechanical protective measures should also be physically evaluated.

For example:

• Are guards sufficiently robust?
• Can a person reach a hazardous area?
• Can components be ejected?
• Can guards be removed unintentionally?
• Are maintenance access points safe?
• Are crushing or shearing points accessible?
• Are safety distances adequate?

This illustrates an important advantage of pre-compliance:

A drawing can appear correct while the actual machine behaves differently.

7.15 Documentation Should Be Built During Development

Pre-compliance is not limited to physical testing.

The technical documentation should also be developed progressively.

The Machinery Directive requires technical documentation covering, among other things:

• General description
• Drawings
• Control-circuit diagrams
• Calculations
• Test results
• Risk assessment
• Applied standards
• Technical reports
• Operating instructions
• And other relevant information.

It is therefore much more efficient to collect this information throughout development rather than trying to reconstruct it at the end.

7.16 A Test Report Is Only Useful If It Relates to the Actual Machine

A test report should clearly identify:

• Which product was tested
• Which configuration was tested
• When the test was performed
• Under which conditions
• Which methods were used
• Which results were obtained
• And which deviations were identified

The exact product configuration is particularly important.

If, after testing:

• The motor is changed
• The controller is changed
• A guard is changed
• The electrical architecture is changed
• Or the software is changed

the manufacturer should determine whether the previous test results remain valid.

7.17 “Tested” Does Not Automatically Mean “Compliant”

This distinction is extremely important.

A test answers a specific technical question.

For example:

“Does the machine achieve the required stopping time under the specified conditions?”

Conformity assessment asks a much broader question:

Does the machine comply with all requirements applicable to it?

One successful test can therefore never, by itself, demonstrate full machine compliance.

7.18 Pre-Compliance Should Be Risk-Based

Not every machine requires the same pre-compliance activities.

A simple machine with limited movement may require a very different assessment from:

• A complex robotic system
• A high-speed machine
• A press
• An automated production line
• Or a machine containing several forms of hazardous energy

The test strategy should therefore reflect the actual risks of the machine.

7.19 What Should Be Tested First?

A practical prioritization can be:

1. Critical safety functions

Are the fundamental protective functions technically feasible and correctly implemented?

2. Fundamental design issues

Are there hazards that can only be addressed by changing the mechanical design?

3. Safety-related control systems

Are the architecture and required performance level or SIL concept appropriate?

4. Electrical safety

Are there fundamental electrical safety problems?

5. EMC

Are there obvious emissions or immunity problems?

6. Product-specific testing

Depending on the machine:

• Noise
• Pressure
• Temperature
• Radiation
• Vibration
• Functional safety

7.20 Fail Early

The objective of pre-compliance is not to perform as many tests as possible as early as possible.

The objective is:

Identify critical problems as early as possible.

A problem discovered during the concept phase is generally much easier to solve than a problem discovered after series production has started.

Pre-compliance should therefore focus particularly on issues where late changes would be expensive or technically difficult.

7.21 Common Mistake: Testing Only When the Machine Is Finished

A traditional development sequence might look like:

Design

→

Manufacturing

→

Assembly

→

Commissioning

→

Laboratory testing

→

Problem discovered

→

Modification

→

Retesting

This can create substantial delays.

A better process is:

Design

→

Risk assessment

→

Define critical safety functions

→

Early verification

→

Prototype

→

Pre-compliance

→

Optimization

→

Final compliance

7.22 Common Mistake: Expecting the Laboratory to “Make the Machine Compliant”

A test laboratory can perform tests and provide technical results.

The responsibility for machine conformity, however, remains with the manufacturer.

The Machinery Directive assigns the manufacturer responsibility for the risk assessment, technical documentation, and conformity assessment.

A laboratory report can therefore be an important item of evidence, but it does not transfer the manufacturer’s legal responsibility to the laboratory.

7.23 Common Mistake: Ignoring Changes After Testing

This is one of the most common practical problems.

A machine is tested.

Afterwards, components are changed.

For example:

• Different motor
• Different PLC
• Different safety PLC
• Different frequency converter
• Different guard
• Different sensors
• New software version

The manufacturer then assumes:

“The machine has already been tested.”

That conclusion may not be justified.

After a modification, the manufacturer should determine whether it affects:

• The risk assessment
• Safety functions
• Applied standards
• Tests
• Existing evidence

and whether additional verification or testing is required.

7.24 Pre-Compliance for Series-Produced Machines

For series-produced machines, another issue becomes important.

The tested machine needs to be representative of the production version.

If the series product differs significantly from the tested configuration, the relevance of the test results may be affected.

The Machinery Directive requires appropriate internal measures for series production to ensure continued conformity with the relevant requirements and technical documentation.

7.25 Pre-Compliance and Technical Documentation Belong Together

A particularly effective approach is to link every result directly to the technical documentation.

For example:

Hazard

→ Crushing point

Protective measure

→ Guarded access with interlocking

Standard

→ Relevant requirements from EN ISO 14119 / EN ISO 14120

Test

→ Interlocking function test

Result

→ Passed

Evidence

→ Test report XYZ

This creates a traceable chain from the original hazard all the way to the evidence demonstrating how it was addressed.

7.26 A Practical Pre-Compliance Model for Machinery

A structured process can look like this:

Step 1 – Product Scoping

• Identify the machine
• Define intended use
• Determine operating modes
• Define users and operating environment

↓

Step 2 – Regulatory Scoping

• Determine applicable machinery legislation
• Identify additional EU legislation
• Identify relevant standards

↓

Step 3 – Risk Assessment

• Identify hazards
• Assess risks
• Define protective measures
• Document residual risks

↓

Step 4 – Safety Design Review

• Mechanical protective measures
• Safety controls
• Sensors
• Interlocking
• Emergency stop
• Operating modes

↓

Step 5 – Pre-Compliance Testing

• Functional safety testing
• Electrical safety checks
• EMC pre-compliance
• Mechanical testing
• Other product-specific testing

↓

Step 6 – Corrective Actions

• Analyze problems
• Modify the design
• Modify software
• Improve protective measures

↓

Step 7 – Verification & Validation

• Verify protective measures
• Validate safety functions
• Repeat testing where necessary

↓

Step 8 – Final Compliance

• Complete technical documentation
• Perform conformity assessment
• Prepare the Declaration of Conformity
• Apply CE marking
• Complete operating instructions
• Release the production version

7.27 Pre-Compliance Is Particularly Valuable for Complex Machines

The more complex a machine is, the more interfaces it typically contains.

For example:

• Mechanical systems
• Electrical systems
• Pneumatics
• Hydraulics
• Software
• Sensors
• Drives
• Robotics
• Network communication
• Safety systems

can all interact.

A failure at one interface can therefore affect several safety functions.

Pre-compliance makes it possible to identify these interactions before the machine reaches the final assessment stage.

7.28 Changes to the Safety Architecture Are Particularly Critical

Not every machine modification has the same significance.

Changing a simple cover may require a different assessment from changing:

• The safety PLC
• Safety architecture
• Drive technology
• Emergency-stop circuit
• Safety-related software

Change management should therefore be an integral part of the compliance process.

7.29 Pre-Compliance Should Be Documented

Pre-compliance activities should not exist only as informal discussions.

The manufacturer should record:

• What was tested
• Why it was tested
• Which configuration was used
• Which method was used
• What result was obtained
• Which deviations were identified
• Which corrective actions were defined
• Whether retesting is required

Such information can later become valuable evidence within the technical documentation.

The Machinery Directive expressly includes technical reports and test results among the elements of the technical documentation.

7.30 What Pre-Compliance Cannot Do

Pre-compliance is valuable, but it has clear limits.

It cannot automatically:

• Replace the complete risk assessment
• Replace the technical documentation
• Replace the Declaration of Conformity
• Replace the required conformity assessment
• Replace the involvement of a notified body where required
• Or transfer responsibility away from the manufacturer

It is a risk-reduction and development tool.

7.31 The Economic Benefit

The greatest economic benefit of pre-compliance is that problems are addressed while design changes are still relatively inexpensive.

A problem can, for example, evolve from:

Concept phase

€ → small design modification

↓

Prototype

€€ → mechanical redesign

↓

Pre-series

€€€ → redesign + retesting

↓

Series production

€€€€ → production changes + rework

↓

Delivered machines

€€€€€ → field modifications + service + potential corrective actions

The actual cost impact will obviously depend on the machine and the problem involved.

But the underlying principle is clear:

The later a compliance problem is discovered, the more expensive its correction can become.

7.32 The Key Concept

Pre-compliance should not be understood as:

“We test the machine early so that we can get a certificate later.”

Its real purpose is:

Use compliance knowledge during development so that the machine is designed from the beginning in a way that makes the applicable requirements achievable and demonstrable.

This fundamentally changes the role of compliance.

Compliance does not become the final step of machine development.

It becomes part of machine development itself.

7.33 Summary

A professional machine manufacturer should not wait until the end of development to consider compliance.

The Machinery Directive requires a risk assessment and provides for the necessary investigations and tests as part of demonstrating compliance. The results of these activities form part of the technical documentation.

Pre-compliance provides a practical way of implementing this principle throughout development.

The ideal process is:

Define the product

↓

Determine the legal framework

↓

Identify risks

↓

Develop the safety concept

↓

Implement the design

↓

Test early

↓

Correct problems

↓

Verify again

↓

Perform final conformity assessment

↓

Complete technical documentation

↓

Place the machine on the market

The most important principle is therefore:

The best compliance test is one in which the critical problems have already been identified and resolved before the final assessment begins.

Official Sources

• EUR-Lex – Machinery Directive 2006/42/EC
• European Commission – Machinery
• EUR-Lex – Machinery Regulation (EU) 2023/1230

8. Technical Documentation – Building the Evidence of Machinery Compliance

Compliance is not established simply because a machine appears to be safe or because a number of tests have been successfully completed.

A manufacturer must also be able to demonstrate how the machine was assessed, which requirements were considered, which risks were identified, which protective measures were implemented, and why the final machine can be considered compliant.

This is the purpose of the technical documentation.

Under the Machinery Directive, the technical file must demonstrate that the machinery complies with the requirements of the Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for the conformity assessment. (EUR-Lex)

For manufacturers, this makes the technical documentation much more than an administrative file.

It is the evidence structure behind the conformity claim.

8.1 What Is the Technical Documentation?

The Machinery Directive refers to the documentation for machinery as the technical file.

The technical file must contain sufficient information to demonstrate conformity with the applicable requirements.

It is not necessarily a single physical folder.

It can consist of a structured collection of:

• Drawings
• Design information
• Calculations
• Risk assessments
• Control-system documentation
• Test results
• Certificates
• Applied standards
• Technical reports
• Operating instructions
• Declarations
• And other relevant evidence

The Directive specifically states that the technical file must cover the design, manufacture and operation of the machinery to the extent necessary for the conformity assessment. (EUR-Lex)

8.2 Why the Technical File Matters

The technical file serves several purposes.

It allows the manufacturer to demonstrate that:

1. The machine was properly assessed.
2. Applicable requirements were identified.
3. Risks were systematically considered.
4. Protective measures were implemented.
5. The design corresponds to the assessed machine.
6. Necessary tests and calculations were performed.
7. The final machine can be linked to the evidence supporting its conformity.

It also allows competent authorities to investigate the manufacturer’s conformity claim if necessary.

The Machinery Directive provides that the technical file must be made available to the competent national authorities upon a duly reasoned request. Failure to present it can constitute sufficient grounds for doubting the conformity of the machinery. (EUR-Lex)

8.3 The Technical File Is Not Just a Collection of Documents

One of the most common misunderstandings is to treat technical documentation as a document-storage exercise.

For example:

• one PDF for the risk assessment,
• one test report,
• one electrical drawing,
• one certificate,
• one user manual.

Having these documents does not automatically mean that the technical file is adequate.

The documents need to tell a consistent technical story.

For example:

Risk identified

↓

Protective measure defined

↓

Design implemented

↓

Safety function specified

↓

Relevant standard identified

↓

Verification performed

↓

Result documented

↓

Final machine corresponds to the assessed configuration

This traceability is one of the most valuable characteristics of a well-structured technical file.

8.4 What Does the Technical File Have to Contain?

Annex VII, Part A of the Machinery Directive specifies the technical file requirements.

The construction file includes, among other things:

• A general description of the machinery
• The overall drawing
• Drawings of the control circuits
• Relevant descriptions and explanations necessary to understand the operation
• Detailed drawings where necessary
• Calculation notes
• Test results
• Certificates
• Documentation relating to the risk assessment
• Applied essential health and safety requirements
• Applied standards and technical specifications
• Technical reports
• Instructions for the machinery
• And, where applicable, copies of declarations for incorporated machinery or products. (EUR-Lex)

The exact content depends on the machine and what is necessary to demonstrate conformity.

8.5 The General Description of the Machine

The technical file should begin with a clear understanding of what the machine actually is.

A useful general description can include:

• Product name
• Model
• Type
• Machine family
• Intended purpose
• Main functions
• Main components
• Operating principle
• Operating modes
• Energy sources
• Interfaces
• Intended environment
• Relevant limitations

The description should allow a technically competent person to understand the machine without having to reconstruct its architecture from dozens of separate documents.

8.6 Drawings and Technical Design Information

The technical file should contain the drawings and information necessary to understand the machine and assess its conformity.

Depending on the machine, this can include:

• General arrangement drawings
• Mechanical drawings
• Electrical drawings
• Hydraulic diagrams
• Pneumatic diagrams
• Control-system diagrams
• Safety circuit diagrams
• Assembly drawings
• Relevant component drawings

The Machinery Directive specifically requires the overall drawing and control-circuit drawings as part of the construction file. (EUR-Lex)

8.7 How Detailed Do the Drawings Need to Be?

The objective is not necessarily to provide every manufacturing drawing ever created.

The technical file needs to contain the information necessary to demonstrate conformity.

The Machinery Directive specifically notes that detailed information on subassemblies does not necessarily have to be included unless knowledge of that information is indispensable for verifying conformity with the essential health and safety requirements. (EUR-Lex)

This is an important distinction.

The technical file should be complete enough for conformity assessment, but it does not automatically need to contain every internal manufacturing detail.

8.8 The Risk Assessment Is a Core Part of the Technical File

The risk assessment is one of the most important elements of the technical documentation.

The manufacturer must determine the health and safety requirements applicable to the machine through a risk assessment and then design and construct the machine taking the results into account. (EUR-Lex)

The technical file should therefore allow a reviewer to understand:

• Which hazards were identified
• How the risks were evaluated
• Which protective measures were selected
• Which risks remain
• How residual risks are addressed
• Which requirements apply
• How the implemented measures were verified

The risk assessment should not be treated as a standalone document disconnected from the rest of the technical file.

8.9 The Risk Assessment Should Match the Final Machine

A particularly important principle is:

The risk assessment must describe the machine that actually exists.

Suppose the original design used:

• Drive A
• Safety PLC A
• Guard A

but the final machine uses:

• Drive B
• Safety PLC B
• Guard B

The manufacturer should not simply leave the original risk assessment unchanged.

The changes need to be assessed for their potential impact on the identified hazards and protective measures.

8.10 Applied Standards Should Be Documented

The technical documentation should identify the standards and technical specifications used during the design and conformity assessment process.

This can include standards relating to:

• Machinery safety
• Electrical equipment
• Functional safety
• Guards
• Interlocking
• Emergency stop
• EMC
• Noise
• Specific machine types
• Specific technologies

However, simply listing standards is not enough.

The manufacturer should understand which parts of the machine or which requirements are actually addressed by each standard.

8.11 A Standard Is Not a Substitute for a Risk Assessment

A common mistake is:

“We used the relevant machine standard, therefore the machine is safe.”

That is not a sufficient compliance approach.

Standards can provide technical solutions and conformity mechanisms, but the manufacturer still needs to determine the risks associated with the actual machine.

The Machinery Directive explicitly establishes the risk assessment as a fundamental part of the process. (EUR-Lex)

8.12 Test Results

Test results form another important part of the technical documentation.

Depending on the machine, this can include:

• Electrical safety tests
• Functional safety tests
• Safety-function verification
• EMC testing
• Noise measurements
• Mechanical testing
• Temperature measurements
• Pressure tests
• Performance measurements
• Protective-device tests
• Other machine-specific testing

The relevant reports should be traceable to the actual machine and configuration tested.

8.13 Certificates

Certificates can also form part of the technical file.

Examples can include documentation for:

• Safety components
• Motors
• Drives
• Sensors
• Safety controllers
• Pressure equipment
• Electrical components
• Other incorporated products

However:

A component certificate does not automatically demonstrate conformity of the complete machine.

A certified safety component may be appropriate for a particular application, but the manufacturer still needs to consider how it is integrated into the machine.

8.14 Supplier Documentation Is Supporting Evidence

Supplier documentation can be extremely useful.

For example, a supplier may provide:

• Declaration of Conformity
• Certificate
• Datasheet
• Safety manual
• Test report
• Technical specification
• Installation instructions

These documents can support the manufacturer’s conformity assessment.

But the manufacturer of the final machine remains responsible for assessing the complete machine.

The question is therefore not simply:

“Is this component CE marked?”

but:

“Is this component suitable for the intended application, and does its integration into the machine satisfy the applicable requirements?”

8.15 Technical Documentation and Incorporated Products

Modern machines often contain numerous purchased products.

Examples include:

• Motors
• Frequency converters
• PLCs
• Sensors
• Industrial PCs
• Power supplies
• Communication modules
• Safety controllers
• Pneumatic components
• Hydraulic components

The technical file should make it possible to understand how relevant components contribute to the overall machine architecture.

This becomes particularly important where a component is part of a safety function.

8.16 Software Documentation

For modern machinery, software can be an important part of the technical documentation.

Depending on the machine, this may include:

• Software architecture
• Safety software
• Version information
• Parameter settings
• Safety logic
• Configuration files
• Relevant source or compiled code information
• Validation results
• Change history

The level of documentation should reflect the significance of the software to the machine’s safety and conformity.

8.17 Version Control Is Critical

A technical file becomes much less useful if nobody can determine which version of the machine the documents describe.

A professional documentation system should therefore provide clear identification of:

• Machine model
• Serial number or product family
• Hardware revision
• Software revision
• Drawing revision
• Risk assessment revision
• Test report revision
• Manual revision

This allows the manufacturer to establish whether a particular document belongs to a particular machine configuration.

8.18 Change Management

Change management should be closely linked to technical documentation.

A modification to the machine should trigger an assessment of whether documentation needs to be updated.

Examples include:

• New motor
• New drive
• New sensor
• New safety controller
• New software
• Modified guard
• Changed operating mode
• New machine function
• Changed intended use

The manufacturer should determine whether the modification affects:

• Risk assessment
• Applicable requirements
• Applied standards
• Safety functions
• Testing
• Technical drawings
• Operating instructions
• Declaration of Conformity

8.19 The Technical File Should Be Built During Development

Trying to create the technical file at the very end of a project is a risky approach.

A better process is:

Design decision

→ document it

Risk identified

→ document it

Protective measure selected

→ document it

Test performed

→ document it

Design changed

→ update the relevant documents

This avoids the common situation where engineers finish the machine and then discover that important evidence is missing.

8.20 A Practical Technical Documentation Structure

A manufacturer could structure the technical file, for example, as follows:

01 – Product Identification

• Product name
• Model
• Type
• Serial number
• Product family

02 – General Machine Description

• Intended use
• Operating principle
• Operating modes
• Technical specifications

03 – Drawings

• General arrangement
• Mechanical drawings
• Electrical drawings
• Control diagrams
• Pneumatic/hydraulic diagrams

04 – Risk Assessment

• Risk assessment methodology
• Hazard identification
• Risk evaluation
• Protective measures
• Residual risks

05 – Applicable Requirements

• Applicable legislation
• Essential health and safety requirements
• Applicable standards
• Technical specifications

06 – Safety Functions

• Safety architecture
• Safety functions
• Safety calculations
• Verification
• Validation

07 – Test Reports

• Electrical tests
• EMC tests
• Functional safety tests
• Machine-specific tests

08 – Component Documentation

• Supplier declarations
• Certificates
• Datasheets
• Safety documentation

09 – Software

• Software versions
• Safety software
• Configuration
• Validation documentation

10 – Operating Instructions

• User manual
• Installation instructions
• Maintenance instructions
• Safety information

11 – Declarations

• EU Declaration of Conformity
• Relevant declarations for incorporated products
• Other applicable declarations

12 – Change History

• Design changes
• Software revisions
• Risk assessment revisions
• Test revisions

This is not a legally prescribed folder structure. It is a practical way of making the evidence easier to manage and retrieve.

8.21 Traceability Is the Key

A strong technical file should allow a reviewer to follow a clear chain:

Requirement

↓

Hazard

↓

Risk

↓

Protective measure

↓

Design implementation

↓

Applicable standard

↓

Verification

↓

Test result

↓

Final configuration

This is much stronger than simply having a large collection of unrelated documents.

8.22 Example: Guarded Access to a Hazardous Area

Consider a machine containing a rotating tool.

The risk assessment identifies:

Hazard:
Access to the rotating tool during operation.

The manufacturer determines:

Protective measure:
A fixed or movable guard with appropriate interlocking.

The technical documentation can then connect:

• Risk assessment
• Guard design
• Interlocking device
• Safety circuit
• Applicable standards
• Safety calculation
• Functional test
• Validation
• Operating instructions

The result is a complete evidence chain.

8.23 Example: Emergency Stop

A similar approach can be used for an emergency stop.

The documentation should not simply state:

“Emergency stop installed.”

Instead, the technical file should allow the manufacturer to demonstrate:

• Why an emergency stop is required
• Which functions it controls
• Which hazards it addresses
• How it is implemented
• Which components are used
• What happens when it is activated
• How the machine reaches the required safe state
• How the function was verified
• How it was validated

This approach turns the technical file into a technical argument rather than a document archive.

8.24 What About Confidential Information?

Manufacturers sometimes hesitate to provide detailed technical information because of intellectual property concerns.

The Machinery Directive explicitly recognizes that the technical file does not necessarily need to contain detailed information about subassemblies where that information is not necessary for verifying conformity. (EUR-Lex)

The objective is therefore not to disclose every proprietary design detail.

The objective is to provide sufficient evidence to demonstrate conformity.

8.25 Does the Technical File Have to Be Physically Stored at the EU Location?

Not necessarily.

The Machinery Directive states that the technical file does not have to be located within the Community and does not have to be permanently available in physical form. However, it must be capable of being assembled and made available to the competent authority within an appropriate period. (EUR-Lex)

This is particularly relevant for international manufacturers whose engineering and documentation systems are located outside the EU.

8.26 How Long Must the Documentation Be Retained?

For machinery under the Machinery Directive, the technical documentation is generally retained for at least 10 years from the date of manufacture of the machinery, or, in the case of series production, from the date of manufacture of the last unit. The manufacturer must be able to make the documentation available to competent authorities upon request. (European Commission)

This makes document retention and version management an important part of compliance management.

8.27 Technical Documentation for Partly Completed Machinery

Partly completed machinery has a different documentation concept.

The Machinery Directive distinguishes between:

• The technical file for machinery
• Relevant technical documentation for partly completed machinery

For partly completed machinery, the documentation must show which requirements of the Directive have been applied and fulfilled. It also includes relevant design documentation, calculations, test results, certificates and risk assessment information. (EUR-Lex)

The partly completed machinery is accompanied by the relevant documentation and declaration of incorporation until it is incorporated into the final machinery. (EUR-Lex)

This distinction becomes particularly important for manufacturers supplying modules, assemblies or subsystems intended to be incorporated into another machine.

8.28 Common Mistake: Creating the Technical File at the End

One of the most common problems is:

Machine completed

↓

Testing completed

↓

Customer waiting

↓

Someone starts creating the technical file

This often leads to:

• Missing drawings
• Outdated risk assessments
• Missing test results
• Inconsistent component lists
• Incorrect software versions
• Missing supplier documentation
• Contradictions between the machine and the manual

The technical file should instead evolve with the machine.

8.29 Common Mistake: Documents Describe Different Versions

Another frequent problem is inconsistency.

For example:

Drawing: Motor A

Risk assessment: Motor B

Test report: Motor C

Manual: Motor A

Actual machine: Motor D

Individually, each document may appear reasonable.

Together, they create a serious traceability problem.

The technical documentation should therefore be controlled as a system.

8.30 Common Mistake: “CE Certificates” Are Collected Without Evaluation

A manufacturer may collect dozens of supplier certificates and assume that the machine is therefore adequately documented.

But certificates need to be evaluated in context.

The important question is:

What does this document actually demonstrate, and how does it support the conformity of the final machine?

A supplier declaration may demonstrate conformity of a component with certain legislation.

It does not automatically demonstrate conformity of the complete machine.

8.31 Common Mistake: The Test Report Does Not Match the Product

A test report may be technically correct but still have limited value if it does not clearly identify the tested configuration.

A manufacturer should therefore verify:

• Product identification
• Hardware
• Software
• Configuration
• Test conditions
• Applicable standards
• Test date
• Relevant modifications

before relying on a test report as conformity evidence.

8.32 Common Mistake: The Technical File Contains No Clear Compliance Logic

A large technical file is not necessarily a good technical file.

A 500-page document collection can still be difficult to assess if there is no clear connection between:

• Requirements
• Risks
• Design
• Protective measures
• Testing
• Results

A smaller but well-structured technical file can be significantly more useful.

The goal is therefore not:

More documents.

The goal is:

Better evidence and traceability.

8.33 The Technical File as a Compliance Database

For complex machinery, it can be useful to think of the technical file not as a folder but as a compliance database.

Each requirement can be linked to:

• Relevant hazard
• Protective measure
• Component
• Standard
• Test
• Result
• Document
• Machine revision

This approach becomes particularly powerful for manufacturers with:

• Multiple machine variants
• Product families
• Configurable machines
• Series production
• Frequent engineering changes

Instead of rebuilding the compliance documentation for every machine, a controlled structure can be maintained and updated.

8.34 A Strong Technical File Answers Five Questions

A well-structured technical file should allow a reviewer to answer five fundamental questions:

1. What is the machine?

Product identity, purpose, architecture and configuration.

2. What can go wrong?

Hazards and risks identified through the risk assessment.

3. What was done about it?

Protective measures and design decisions.

4. How do we know the measures work?

Calculations, verification, validation and testing.

5. Does the final machine correspond to the evidence?

Configuration control and change management.

If these five questions can be answered clearly, the technical documentation becomes a powerful compliance tool.

8.35 The Technical File Is the Backbone of the Compliance Process

The technical file should not be considered the final administrative step before signing the Declaration of Conformity.

It is the backbone connecting the entire compliance process.

The relationship can be represented as:

Machine

→

Applicable legislation

→

Essential requirements

→

Risk assessment

→

Design

→

Protective measures

→

Standards

→

Verification

→

Validation

→

Test results

→

Technical documentation

→

Declaration of Conformity

The better these elements are connected, the stronger the manufacturer’s conformity case becomes.

8.36 Key Takeaways

The technical documentation is not simply a collection of certificates and test reports.

It is the structured evidence demonstrating how the manufacturer arrived at the conclusion that the machine complies with the applicable requirements.

A strong technical file should:

• Describe the actual machine
• Identify the applicable requirements
• Contain the risk assessment
• Document the design
• Identify relevant standards
• Document protective measures
• Include relevant calculations and tests
• Demonstrate safety-function verification and validation
• Include relevant supplier documentation
• Control hardware and software revisions
• Reflect changes made during development
• Remain consistent with the final machine
• Be retrievable when required

The fundamental principle is:

A compliant machine needs not only to be safe and compliant—it needs to be possible to demonstrate why.

And that is the purpose of the technical file.

Official Sources

• EUR-Lex – Machinery Directive 2006/42/EC, Annex VII – Technical File
• EUR-Lex – Machinery Directive 2006/42/EC, consolidated text
• European Commission – Machinery

9. Conformity Assessment – How Machinery Compliance Is Demonstrated

Conformity assessment is the process by which the manufacturer determines and documents that machinery meets the applicable requirements of the Machinery Directive.

It is important to distinguish between two concepts:

• Conformity: the machinery meets the applicable requirements.
• Conformity assessment: the procedure used to demonstrate that conformity.

The Machinery Directive provides different conformity assessment procedures. The applicable procedure depends, among other things, on what type of machinery is being manufactured and whether it falls within one of the machinery categories listed in Annex IV.

9.1 The Basic Process

For typical machinery, the process can be summarized as:

Define the machinery and its intended use

↓

Determine whether the Machinery Directive applies

↓

Identify the applicable Essential Health and Safety Requirements

↓

Carry out the risk assessment

↓

Implement appropriate technical measures

↓

Identify applicable harmonised standards

↓

Verify conformity and perform the necessary tests

↓

Complete the technical documentation

↓

Carry out the applicable conformity assessment procedure

↓

Prepare the EU Declaration of Conformity

↓

Affix the CE marking

The process should not be treated as a purely formal final step. Each stage builds on the previous one.

9.2 Who Is Responsible for Conformity Assessment?

The responsibility fundamentally lies with the manufacturer.

The manufacturer must ensure that the machinery meets the requirements of the Machinery Directive and that the applicable conformity assessment procedure has been completed.

This also means:

An external laboratory, consultant or other organization does not automatically assume the manufacturer’s responsibility for machinery conformity.

External organizations may perform testing, provide technical support or, where the applicable procedure requires it, act as a Notified Body.

The responsibility for placing the machinery on the market remains with the manufacturer.

9.3 Not Every Machine Requires a Notified Body

This is an important point.

For many types of machinery, the manufacturer can carry out the conformity assessment under its own responsibility.

Involvement of a Notified Body becomes relevant in particular where the machinery falls within certain categories listed in Annex IV and the applicable conformity assessment procedure requires the involvement of a third party.

Therefore, it should not automatically be assumed:

“I need a Notified Body for this machine.”

The correct question is:

Which conformity assessment procedure applies to this specific machine?

9.4 Machinery Listed in Annex IV

Annex IV of the Machinery Directive contains specific categories of machinery for which particular conformity assessment procedures may apply because of their risk characteristics.

Examples include certain:

• saws,
• presses,
• vehicle lifts,
• woodworking machinery,
• portable cartridge-operated fixing and other impact machinery,
• lifting platforms,
• safety components.

The complete list is defined in Annex IV of the Machinery Directive.

Consequently, checking Annex IV should be one of the important early steps in the conformity process.

9.5 Why the Classification Matters

The classification of the machinery can directly influence which conformity assessment procedure must be used.

An incorrect classification can therefore result in the manufacturer applying the wrong conformity assessment procedure.

The decision should not be postponed until the end of the project.

A better approach is:

Identify the machinery

→ Check the scope

→ Check Annex IV

→ Determine the conformity assessment procedure

→ Structure the remaining compliance activities accordingly

9.6 Internal Production Control

For many machines, the Machinery Directive provides for internal production control.

Under this approach, the manufacturer carries out the conformity assessment itself.

The manufacturer must, among other things, ensure that:

• the technical documentation has been established,
• the machinery complies with the applicable requirements,
• the necessary checks and tests have been performed,
• the EU Declaration of Conformity has been prepared,
• and the CE marking is correctly affixed.

The detailed requirements are defined in the conformity assessment procedures of the Machinery Directive.

9.7 The Role of Harmonised Standards

Harmonised standards can play an important role in machinery conformity assessment.

They can provide technical solutions for addressing specific requirements of the Machinery Directive.

Of particular importance is the presumption of conformity, where the relevant harmonised standard has been published in the Official Journal of the European Union and the applicable conditions are fulfilled.

Therefore, a manufacturer should not simply select a standard from a general standards database.

The manufacturer should verify:

• Is the standard actually relevant?
• Is it suitable for the specific machinery?
• Which requirements does it address?
• Which edition is relevant?
• Is it a harmonised standard?
• Has its reference been published in the Official Journal?
• Are there restrictions or qualifications associated with its use?

9.8 A List of Standards Is Not Enough

A common mistake is to create a technical documentation package containing a long list of standards:

• EN ISO 12100
• EN 60204-1
• EN ISO 13849-1
• EN ISO 13850
• EN ISO 14119
• EN ISO 14120
• and so on.

The list alone does not demonstrate how the requirements have been addressed.

A better approach is to establish a traceable relationship:

Requirement / Topic	Standard	Implementation	Evidence
Risk assessment	EN ISO 12100	Risk assessment performed	RA-001
Emergency stop	EN ISO 13850	Emergency-stop circuit	Test report
Interlocking	EN ISO 14119	Safety switch	Validation
Electrical equipment	EN 60204-1	Electrical design	Test report

This creates a compliance matrix.

9.9 The Compliance Matrix

A compliance matrix is not a legally prescribed document format, but it can be an extremely useful compliance tool.

It can contain, for example:

Requirement	Applicable?	Implementation	Evidence	Status
EHSR 1.1.2	Yes	Risk reduction	Risk assessment	Fulfilled
EHSR 1.2.1	Yes	Safety control system	Validation	Fulfilled
EHSR 1.2.4	Yes	Emergency stop	Test report	Fulfilled
EHSR 1.5.1	Yes	EMC measures	EMC report	Fulfilled

Such a matrix makes it easier, particularly for complex machinery, to verify that all relevant requirements have actually been addressed.

9.10 Verification and Testing

As part of conformity assessment, the manufacturer must carry out the necessary checks and verifications.

Different types of evidence may be used.

For example:

Calculation

→ demonstrates that a particular technical design is adequate.

Verification

→ checks whether a defined technical requirement has been met.

Validation

→ confirms that the machinery or safety function is suitable for its intended purpose.

Testing

→ provides a specific functional or measurement-based result.

Not every requirement requires the same type of evidence.

9.11 Conformity Assessment Is More Than a Laboratory Test

A test report can provide important evidence.

However, it does not automatically answer every question concerning machinery conformity.

For example, an EMC test may demonstrate that the machinery meets certain EMC requirements.

It does not automatically demonstrate:

• that the risk assessment is complete,
• that the guards are appropriate,
• that the operating instructions are adequate,
• that the intended use has been correctly defined,
• or that the machinery as a whole meets all applicable requirements.

Therefore, a test report must not be confused with the complete conformity assessment.

9.12 The EU Declaration of Conformity

The EU Declaration of Conformity is an important final element of the conformity process.

Through the declaration, the manufacturer formally takes responsibility for the conformity of the machinery with the applicable requirements.

The Machinery Directive specifies the required content of the EU Declaration of Conformity in Annex II, Part 1, Section A.

Among other things, it includes:

• manufacturer information,
• identification of the machinery,
• where applicable, information concerning the authorised representative,
• the declaration of conformity,
• the relevant legislation,
• applicable standards and/or technical specifications,
• where applicable, information concerning the Notified Body,
• date,
• name and function of the signatory,
• signature.

The declaration must clearly identify the machinery to which it applies.

9.13 The EU Declaration of Conformity Is Not a Certificate

Another common misunderstanding is:

The EU Declaration of Conformity is not a “CE certificate.”

The EU Declaration of Conformity is the manufacturer’s formal declaration that the machinery complies with the applicable requirements.

The CE marking is then the visible conformity marking.

The Machinery Directive does not establish a general requirement for every machine to receive a government-issued or laboratory-issued “CE certificate.”

9.14 The CE Marking

After the applicable conformity assessment has been successfully completed, the CE marking is affixed.

It indicates that the manufacturer declares that the product complies with the EU harmonisation legislation applicable to it.

The CE marking should not be interpreted as a quality mark.

It does not mean:

• “approved by the EU,”
• “tested by the EU,”
• “certified by a laboratory,”
• “particularly safe,”
• or “particularly high quality.”

It is a conformity marking.

9.15 Common Mistake: Applying the CE Marking Too Early

A manufacturer should not simply affix the CE marking because:

• the machine has been completed,
• a test report exists,
• suppliers have provided CE documentation,
• or the customer is waiting for delivery.

The CE marking is part of the conclusion of a properly completed conformity process.

9.16 What Happens When the Machine Is Modified?

A machine that has already undergone conformity assessment may require reassessment after modifications.

This is particularly relevant where modifications:

• introduce new hazards,
• change existing risks,
• affect safety functions,
• change the intended use,
• or substantially alter the technical design.

Therefore, the previous conformity assessment should not automatically be reused after a significant modification.

The manufacturer should first determine:

Does the modification affect conformity?

9.17 Conformity Assessment Is an Ongoing Process

In a professional development process, conformity assessment should not begin only when the machine is finished.

It should accompany the entire development process:

Concept

→ Requirements

→ Risk assessment

→ Design

→ Protective measures

→ Testing

→ Technical documentation

→ Final conformity assessment

→ Declaration

→ CE marking

This reduces the risk of discovering fundamental compliance problems at the very end of the project.

9.18 Practical Checklist

Before completing the conformity assessment, the manufacturer should consider checking:

Product

• Is the machinery clearly identified?
• Is the intended use defined?
• Are relevant variants covered?

Legal requirements

• Does the Machinery Directive apply?
• Are other EU legal acts applicable?
• Has Annex IV been checked?

Risk

• Is the risk assessment complete?
• Does it correspond to the final machinery?
• Are residual risks documented?

Standards

• Have the relevant standards been identified?
• Has the status of the standards been checked?
• Are the standards actually applicable to the machinery?

Technical evidence

• Are calculations available?
• Have the necessary tests been performed?
• Have safety functions been verified and validated?
• Is relevant supplier documentation available?

Documentation

• Are the drawings current?
• Do the hardware and software versions correspond?
• Are the operating instructions complete?
• Is the technical documentation consistent?

Finalization

• Has the correct conformity assessment procedure been applied?
• Is the EU Declaration of Conformity correct?
• Has the CE marking been affixed correctly?

9.19 The Most Important Point

Conformity assessment should not be understood as a single form or final administrative step.

It is the result of a connected technical and legal process.

The manufacturer should not only be able to say:

“Our machine is compliant.”

The manufacturer should be able to demonstrate:

“Here are the applicable requirements, here are the identified risks, here are the measures we implemented, and here is the evidence demonstrating conformity.”

That connection between requirement → risk → technical solution → evidence is what makes a conformity assessment robust.

Official Sources

• EUR-Lex – Directive 2006/42/EC on machinery
• European Commission – Machinery

10. Safety Functions and Control Systems

Safety-related control systems are among the most technically important parts of modern machinery.

A machine may have mechanically effective guards and other protective measures, but if its control system can initiate a hazardous movement unexpectedly, fail to stop the machine when required, or defeat a protective device, the overall safety concept may still be inadequate.

The Machinery Directive therefore contains specific requirements for control systems. Annex I requires control systems to be designed and constructed so that hazardous situations are prevented, including situations resulting from hardware or software faults, errors in control logic, and reasonably foreseeable human error. (EUR-Lex)

For many machines, this leads to the concept of safety functions: specific functions implemented by the control system to reduce identified risks.

10.1 When Does a Control Function Become Safety-Relevant?

Not every function performed by a machine’s control system is automatically a safety function.

A conventional control function may determine:

• motor speed,
• production quantity,
• temperature,
• conveyor movement,
• positioning,
• process timing.

A safety function, in contrast, is a control function whose failure could lead to a hazardous situation.

Examples include:

• stopping a hazardous movement when a guard is opened,
• preventing unexpected start-up,
• stopping a machine when a light curtain is interrupted,
• limiting hazardous movement to a safe speed,
• preventing simultaneous conflicting movements,
• monitoring a safety-related position,
• ensuring that a hazardous movement cannot start until specified conditions are fulfilled.

The identification of safety functions should therefore originate from the risk assessment.

10.2 Safety-Related Parts of Control Systems

The Machinery Directive specifically addresses the safety and reliability of control systems.

The control system must be designed so that foreseeable faults do not lead to hazardous situations. This includes faults in both hardware and software, as well as errors in the control logic. (EUR-Lex)

This can involve a combination of:

• sensors,
• switches,
• relays,
• safety relays,
• programmable safety controllers,
• PLCs,
• contactors,
• drives,
• actuators,
• monitoring systems,
• safety-related software.

The complete chain must be considered.

For example:

Guard switch

→

Safety controller

→

Output

→

Contactor / drive

→

Motor

A safety function is not necessarily safe simply because one component in this chain is labelled “safety”.

The complete function must achieve the required level of risk reduction.

10.3 From Hazard to Safety Function

A useful way to approach the design is to start with the hazard.

Consider a machine with an accessible rotating tool.

The risk assessment identifies:

Hazard:
Contact with the rotating tool.

Risk reduction:
Prevent access while the tool is rotating.

This may result in a safety function such as:

Opening the protective guard shall prevent or stop the hazardous movement.

The technical implementation could then involve:

• a guard interlock switch,
• a safety controller,
• a monitored stopping function,
• a drive with an appropriate safety function.

The exact solution depends on the machine and the risk.

10.4 Safety Functions Should Be Clearly Defined

A safety function should be described in a way that makes its intended behaviour unambiguous.

For example:

SF-01 – Guard monitoring:
Opening the access guard shall initiate the defined safe stopping function of the hazardous drive.

A useful safety-function specification can include:

• initiating condition,
• hazardous function,
• required response,
• stopping behaviour,
• reset behaviour,
• restart conditions,
• operating modes,
• required performance level,
• relevant assumptions.

This provides a direct connection between the risk assessment and the engineering design.

10.5 Performance Level

For many machinery applications, the required reliability of a safety-related control function is evaluated using Performance Level (PL) according to EN ISO 13849-1.

The standard provides a methodology for designing and evaluating safety-related parts of control systems.

The Performance Level is designated:

PL a → PL b → PL c → PL d → PL e

with PL e representing the highest level in this classification.

The required Performance Level is normally determined from the risk associated with the safety function.

It is important to distinguish between:

Required Performance Level (PLr)

and

Achieved Performance Level (PL).

The design must achieve at least the required level.

10.6 Determining the Required Performance Level

The required performance level is not selected simply because a machine uses a particular type of component.

It should be derived from the risk associated with the specific safety function.

EN ISO 13849-1 provides a risk-graph methodology that considers factors including:

• severity of injury,
• frequency and/or duration of exposure,
• possibility of avoiding or limiting the hazard.

This results in a required Performance Level.

For example:

Risk assessment

↓

Safety function identified

↓

PLr determined

↓

Safety-related control system designed

↓

Achieved PL calculated

↓

Validation

The achieved performance must satisfy the requirement established by the risk assessment.

10.7 Performance Level Is Not the Same as Safety Integrity Level

Performance Level (PL) and Safety Integrity Level (SIL) are two different concepts.

PL is primarily associated with the machinery safety methodology of EN ISO 13849-1.

SIL is used within the IEC 61508 family and related functional-safety standards, and is also used in machinery-related standards such as IEC 62061.

They are not simply two names for the same calculation.

There are relationships between the concepts, and both can be used in appropriate machinery applications, but the manufacturer must use the methodology applicable to the selected standard and safety architecture.

10.8 SIL and Machinery Safety

IEC 62061 provides a machinery-specific methodology based on Safety Integrity Level.

The choice between a PL-based approach and an SIL-based approach depends on the applicable standards, the design methodology and the safety function.

A manufacturer should avoid mixing calculation methods without understanding their underlying assumptions.

The important question is not:

“Should we always use PL or always use SIL?”

It is:

“Which functional-safety methodology is appropriate for this machine and this safety function?”

10.9 Architecture Matters

Achieving a particular safety level is not simply a matter of selecting a component with a corresponding safety rating.

The architecture of the safety-related control system is important.

Relevant factors can include:

• redundancy,
• diagnostic coverage,
• common-cause failures,
• component reliability,
• fault detection,
• system architecture,
• behaviour under faults.

Two systems using components with similar individual specifications can therefore have different overall safety performance.

10.10 Safety Components

Safety-related components can include:

• guard switches,
• interlocking devices,
• emergency-stop devices,
• safety light curtains,
• pressure-sensitive devices,
• two-hand control devices,
• safety relays,
• safety PLCs,
• safety-rated drives,
• safety-rated contactors.

However, the presence of a safety component does not automatically prove that the machine’s safety function is adequate.

The component must be correctly selected, installed, configured and integrated into the overall safety function.

10.11 Guard Doors and Interlocking

A common safety function is monitoring access to a hazardous area.

For example:

Guard closed

→ machine permitted to operate

Guard opened

→ hazardous movement must enter the defined safe state

The actual implementation can vary.

Depending on the risk, the system may require:

• monitoring of the guard position,
• prevention of restart while the guard is open,
• monitoring of stopping,
• locking of the guard until hazardous movement has ceased.

The appropriate solution must come from the risk assessment.

10.12 Emergency Stop Functions

Emergency stop functions are specifically addressed by Annex I.

Machinery must generally be equipped with one or more emergency-stop devices where they are necessary to avert actual or impending danger, subject to the exceptions specified by the Directive. The emergency stop must be readily accessible and must stop the hazardous process as quickly as possible without creating additional risks. (EUR-Lex)

The Directive also makes an important point:

An emergency stop is a backup to other safeguarding measures, not a substitute for them. (EUR-Lex)

This distinction is often misunderstood.

An emergency stop does not justify leaving a normally accessible hazardous moving part unguarded simply because an operator could press the emergency-stop button.

10.13 Emergency Stop Does Not Automatically Mean “Remove All Energy”

The required response to an emergency stop depends on the machine.

The goal is to bring the hazardous process into a safe condition as quickly as possible without introducing additional risks.

In some applications, immediately removing all energy may itself create a hazard.

For example, stopping a particular process abruptly could:

• release a load,
• create uncontrolled movement,
• cause material to fall,
• disable a necessary holding function.

The stopping strategy must therefore be determined based on the machine’s hazards.

10.14 Normal Stop, Operational Stop and Emergency Stop

The Machinery Directive distinguishes between different stopping functions.

Normal stop

The machine must have a means of being safely brought to a complete stop.

Operational stop

For certain applications, stopping may need to occur while energy remains supplied to actuators. In such cases, the stop condition must be monitored and maintained.

Emergency stop

The emergency stop is intended to avert actual or impending danger.

These functions should not simply be treated as interchangeable.

The technical design must reflect the purpose of each function. (EUR-Lex)

10.15 Preventing Unexpected Start-Up

Unexpected start-up is one of the important hazards addressed by the Machinery Directive.

The control system must be designed so that foreseeable faults and operating situations do not cause hazardous unexpected movement. (EUR-Lex)

Potential scenarios include:

• power returning after an outage,
• resetting a protective device,
• closing a guard,
• switching operating modes,
• restoring a communication connection,
• restarting after maintenance,
• changing a control parameter.

A particularly important principle is:

Resetting a safety device should not itself create an unexpected restart unless the complete safety concept specifically permits and controls that behaviour.

10.16 Reset Functions

Reset is frequently misunderstood.

Suppose a light curtain has been interrupted.

A typical sequence might be:

Light curtain interrupted

↓

Hazardous movement stops

↓

Person leaves hazardous area

↓

Light curtain becomes clear

↓

Reset

↓

Machine can be restarted

The machine should not necessarily restart automatically as soon as the light curtain becomes clear.

The exact behaviour must be determined by the risk assessment and applicable standards.

10.17 Operating Modes

Machines frequently have several operating modes, for example:

• automatic operation,
• manual operation,
• setup,
• maintenance,
• cleaning,
• service,
• programming.

Different operating modes may require different protective measures.

The Machinery Directive states that where different operating modes require different protective measures or working procedures, the machine must have an appropriate mode-selection system. The selected mode must override other operating modes, with the exception of the emergency stop. (EUR-Lex)

This becomes particularly important where guards need to be opened during setup or maintenance.

10.18 Reduced-Speed or Setup Operation

Certain machines need to operate with guards displaced or protective devices temporarily disabled for specific operations.

This does not mean that all protection can simply be bypassed.

The Machinery Directive establishes specific conditions for such situations, including restrictions on the hazardous functions and requirements for maintaining reduced-risk conditions. (EUR-Lex)

The design should therefore make it technically difficult or impossible to accidentally select a hazardous combination of operating conditions.

10.19 Safety Functions and Drives

Modern machinery frequently uses electronically controlled drives.

Safety-related functions may include:

• Safe Torque Off (STO),
• safe limited speed,
• safe stop,
• safe direction,
• safe brake control,
• safe limited position.

Which function is required depends entirely on the hazard.

For example, simply removing torque from a motor may not be sufficient if:

• gravity can move the load,
• stored energy remains,
• the load can coast,
• an external force can cause movement.

The complete hazardous movement must therefore be considered.

10.20 Software Can Become Safety-Relevant

Modern machines increasingly rely on software.

Software may control:

• safety logic,
• interlocks,
• operating modes,
• speed limits,
• position monitoring,
• fault detection,
• reset behaviour.

Where software performs safety-related functions, the development and validation process becomes part of the safety assessment.

The Machinery Directive explicitly requires control systems to account for faults in software and errors in control-system logic that could lead to hazardous situations. (EUR-Lex)

10.21 Safety PLCs Do Not Automatically Make a Machine Safe

A common misconception is:

“We use a safety PLC, therefore the machine is safe.”

This is not sufficient.

The safety PLC is only one part of the system.

The manufacturer must still consider:

• input devices,
• logic,
• output devices,
• actuators,
• wiring,
• diagnostics,
• configuration,
• software,
• reset logic,
• fault behaviour,
• mechanical behaviour.

A highly rated safety controller cannot compensate for an inadequately designed actuator chain.

10.22 Validation of Safety Functions

After the safety-related control system has been designed and implemented, the safety functions must be validated.

Validation asks a fundamental question:

Does the implemented safety function actually behave as intended?

For example, for a guard-interlocking function:

1. Open the guard.
2. Verify that the required safety function is triggered.
3. Verify that hazardous movement stops as required.
4. Verify that restarting is prevented where required.
5. Check relevant fault conditions.
6. Verify reset behaviour.
7. Document the result.

EN ISO 13849-2 specifically addresses validation of safety-related parts of control systems, while EN ISO 13849-1 addresses their design principles. Both standards are included among the harmonised machinery standards referenced by the European Commission. (EUR-Lex)

10.23 Validation Is More Than Functional Testing

A simple functional test such as:

“The emergency-stop button stopped the motor.”

may not be sufficient.

Depending on the safety function, validation can require consideration of:

• correct system architecture,
• component characteristics,
• fault detection,
• diagnostic coverage,
• common-cause failures,
• software,
• response times,
• stopping distance,
• foreseeable faults.

The validation should therefore be appropriate to the safety function and the methodology used.

10.24 Safety Distance and Response Time

For protective devices such as light curtains, the physical position of the device can be safety-critical.

If the machine takes too long to stop, a person may be able to reach the hazard before the dangerous movement has ceased.

The safety distance can therefore depend on factors such as:

• approach speed,
• detection capability,
• control-system response time,
• stopping time,
• machine movement after the stop command.

Standards such as EN ISO 13855 provide specific methodology for positioning safeguards relative to the approach speeds of parts of the human body. The standard is listed among the harmonised machinery standards published by the Commission. (EUR-Lex)

10.25 Common Mistakes

Mistake 1 – Selecting the safety component first

The manufacturer buys a safety switch or safety PLC and then tries to build the safety function around it.

The correct sequence is the opposite:

Risk → safety function → required performance → architecture → components.

Mistake 2 – Assuming a safety component guarantees safety

A safety-rated component does not automatically make the entire safety function compliant.

Mistake 3 – Using the emergency stop as the primary safeguard

The emergency stop is a backup safety measure, not a replacement for appropriate guarding. (EUR-Lex)

Mistake 4 – Ignoring restart behaviour

The machine stops correctly but restarts automatically when a guard is closed or power returns.

Mistake 5 – Ignoring maintenance and setup modes

The automatic operating mode is safe, but technicians can access hazardous areas during setup or maintenance without equivalent risk reduction.

Mistake 6 – Validating only the normal operating condition

The safety function works under normal conditions but has not been assessed for foreseeable faults.

Mistake 7 – Treating software as ordinary software

Safety-related software is treated like standard application software without appropriate development and validation controls.

10.26 A Practical Safety-Function Workflow

A structured workflow can look like this:

Step 1 – Identify the hazard

What hazardous situation needs to be controlled?

Step 2 – Define the safety function

What must the machine do to reduce the risk?

Step 3 – Determine the required performance

What level of reliability is required?

Step 4 – Select the methodology

For example, PL-based or SIL-based methodology as appropriate.

Step 5 – Design the architecture

Determine the sensors, logic, outputs and actuators.

Step 6 – Select suitable components

Choose components capable of supporting the required safety performance.

Step 7 – Implement the function

Build the hardware and software.

Step 8 – Calculate or assess the achieved performance

Determine whether the implemented architecture reaches the required level.

Step 9 – Validate

Test the safety function, including relevant fault conditions.

Step 10 – Document

Record the safety function, design assumptions, calculations, tests and validation results.

10.27 Example: Guard Door on an Automated Machine

Consider an automated machine with an enclosure around a robotic movement.

Hazard

The robot can move at a speed capable of causing serious injury.

Protective measure

Access to the robot area is controlled by an interlocked door.

Safety function

Opening the door shall prevent or stop hazardous robot movement.

Design

The system may include:

• safety-rated guard switch,
• safety controller,
• safety-related output,
• drive safety function.

Required performance

The required performance is determined from the risk assessment.

Validation

The manufacturer verifies:

• door opening detection,
• stopping response,
• restart prevention,
• relevant fault behaviour,
• correct reset behaviour.

Documentation

The result is documented in the technical file.

This is the correct way to connect:

Risk assessment → safety function → engineering → validation → technical documentation.

10.28 Safety Functions in Assemblies of Machinery

Complex installations can contain several interconnected machines.

For example:

Machine A

→ conveyor

→ Machine B

→ robot

→ Machine C

A safety function may need to affect more than one machine.

The Machinery Directive specifically requires that, where machinery or parts of machinery are designed to work together, stopping functions — including emergency stops — must be capable of stopping related equipment where continued operation could be dangerous. (EUR-Lex)

This means that safety cannot always be assessed machine by machine.

The interfaces between machines can themselves create hazards.

10.29 Safety Functions and the Technical Documentation

The technical documentation should provide sufficient evidence that the safety functions have been properly designed and implemented.

Depending on the machine, relevant documentation can include:

• safety-function specifications,
• risk assessment,
• safety circuit diagrams,
• control-system architecture,
• PL calculations,
• SIL calculations where applicable,
• component specifications,
• software documentation,
• validation plans,
• validation results,
• test records.

The objective is traceability.

An auditor, authority or technical reviewer should be able to understand:

Why was this safety function required, how was it implemented, and how was it verified?

10.30 Summary

Safety functions and control systems are a central part of machinery safety.

A robust approach should:

• derive safety functions from the risk assessment,
• clearly define the required safety behaviour,
• distinguish normal control functions from safety functions,
• determine the required performance,
• select an appropriate functional-safety methodology,
• design the complete safety-related control architecture,
• select appropriate components,
• consider hardware and software faults,
• address operating modes and restart behaviour,
• validate the implemented safety functions,
• and document the complete process.

The key principle is:

Do not start with the safety component. Start with the hazard and determine what the machine must safely do.

The component, architecture, performance level and validation method should then follow from that requirement.

Official Sources

• EUR-Lex – Directive 2006/42/EC, Annex I
• European Commission – Machinery sector and guidance
• European Commission – Harmonised standards for machinery
• Commission Implementing Decision (EU) 2023/1586 – Harmonised machinery standards

11. Electrical Equipment, EMC and Power Supply

Electrical equipment is an integral part of modern machinery. It is responsible not only for supplying energy, but often also for controlling movements, implementing safety functions, operating drives, processing sensor signals and communicating with other machines and systems.

As a result, several aspects have to be considered together:

• electrical safety,
• power supply,
• protection against electric shock,
• protective bonding,
• overcurrent protection,
• stored energy,
• control systems,
• drives,
• electromagnetic compatibility (EMC),
• electrostatic phenomena,
• and safe behavior during faults and power interruptions.

The Machinery Directive contains specific requirements concerning electrical hazards and other hazards associated with machinery. Annex I requires machinery with an electrical power supply to be designed and constructed so that, or be equipped so that, all hazards of an electrical nature are prevented or can be prevented.

A key point is therefore:

Electrical safety is not a separate topic from machinery safety. It is part of the safety and conformity assessment of the complete machine.

Other EU legislation may also apply depending on the product. The applicable legal framework must therefore be determined for the specific machine rather than assumed solely from the fact that it contains electrical equipment.

11.1 Electrical Safety as Part of Machinery Compliance

Electrical hazards can arise from, for example:

• dangerous contact voltages,
• inadequate insulation,
• inadequate protective conductors,
• short circuits,
• excessive current,
• overheating,
• incorrect wiring,
• unexpected machine start-up,
• stored electrical energy,
• electrostatic charge,
• malfunctioning electrical components.

Electrical safety should therefore not be assessed independently from the rest of the machine.

An electrical fault may, for example:

• disable a protective device,
• cause an unexpected motor start,
• prevent a drive from stopping,
• cause a brake to release,
• cause overheating,
• create a fire hazard.

Electrical safety and functional machine safety can therefore be closely interconnected.

11.2 The Machinery Directive and Electrical Hazards

Annex I, Section 1.5.1 of the Machinery Directive specifically addresses hazards due to the electrical supply.

Machinery supplied with electrical energy must be designed, constructed and equipped so that all hazards of an electrical nature are prevented or can be prevented.

The Machinery Directive also contains an important relationship with other legislation.

The safety objectives of the Low Voltage Directive are taken into account for machinery. However, the conformity assessment and placing on the market or putting into service of machinery with regard to electrical hazards are governed by the Machinery Directive.

This is important because a common assumption is:

“The machine is electrical and operates at a certain voltage, so we simply apply the Low Voltage Directive separately.”

That is not necessarily correct.

The applicable legislation must be determined based on the specific product and the applicable legal framework.

11.3 Electrical Safety Starts with the Energy Supply

The assessment should begin with the machine’s energy sources.

Typical sources include:

• mains power,
• DC power,
• batteries,
• rechargeable batteries,
• external power supplies,
• industrial power supplies,
• UPS systems,
• pneumatic energy,
• hydraulic energy,
• mechanical energy.

A machine with several energy sources must be assessed with respect to all relevant forms of energy.

For example, a machine may be electrically disconnected while still containing:

• pneumatic pressure,
• hydraulic pressure,
• mechanical energy,
• thermal energy,
• stored electrical energy.

Disconnecting the electrical supply therefore does not automatically mean that the machine is safe.

11.4 Isolation and Disconnection of the Energy Supply

Machinery must be designed so that energy sources can be disconnected and isolated where necessary, particularly for maintenance and servicing.

This is relevant for:

• maintenance,
• repair,
• cleaning,
• troubleshooting,
• modification,
• commissioning.

The Machinery Directive requires machinery to be fitted with means to isolate it from all energy sources, where appropriate. Such isolators must be clearly identifiable and, where reconnection could endanger exposed persons, capable of being locked or otherwise secured.

Practical implementations may include:

• main switches,
• disconnectors,
• lockable isolators,
• appropriate protection against unintended reconnection.

The exact solution depends on the machine and its energy architecture.

11.5 Stored Energy

A common mistake is to consider only the energy supply itself.

Dangerous energy can remain after the machine has been switched off.

Examples include:

• capacitors,
• batteries,
• DC links of variable-speed drives,
• UPS systems,
• stored energy in actuators,
• mechanical inertia,
• pressurized systems.

For electrical equipment, for example, a drive’s DC link can retain a hazardous voltage for a period after the incoming supply has been disconnected.

The safety concept should therefore answer:

What energy remains after shutdown, and how is that energy safely eliminated, contained or controlled?

11.6 Protection Against Electric Shock

Protection against electric shock is a fundamental aspect of electrical machinery safety.

Depending on the design, this can involve:

• basic insulation,
• fault protection,
• protective conductors,
• protective bonding,
• enclosures,
• covers,
• appropriate clearances and creepage distances,
• suitable components.

The precise implementation depends on the electrical architecture and protection concept.

For the electrical equipment of machinery, EN 60204-1 – Safety of machinery – Electrical equipment of machines is one of the key technical standards commonly used to address these requirements.

It covers numerous aspects of machine electrical equipment, including:

• electrical power supply,
• protection against electric shock,
• protective bonding,
• control circuits,
• wiring,
• identification,
• enclosures,
• motors,
• electrical equipment,
• testing,
• technical documentation.

However, applying EN 60204-1 does not automatically demonstrate compliance with every requirement applicable to the complete machine.

The machine as a whole still has to be assessed.

11.7 Protective Conductors and Protective Bonding

A reliable protective conductor and suitable protective bonding are fundamental parts of many electrical protection concepts.

The assessment should not be limited to the main electrical cabinet.

Relevant conductive parts may include:

• the control cabinet,
• machine frames,
• motors,
• drives,
• movable machine sections,
• doors and covers,
• external conductive components.

A common mistake is:

“The control cabinet is grounded, therefore the entire machine is protected.”

The actual electrical design must ensure that all relevant conductive parts are appropriately addressed by the selected protection concept.

11.8 Short-Circuit and Overcurrent Protection

Electrical circuits must be appropriately protected against relevant fault conditions.

Depending on the machine, this may involve:

• fuses,
• circuit breakers,
• motor protection,
• electronic protection functions,
• overload protection.

The protection must be suitable for the actual electrical architecture.

Relevant parameters may include:

• rated current,
• prospective short-circuit current,
• conductor cross-section,
• breaking capacity,
• motor characteristics,
• ambient temperature,
• operating conditions.

Protection devices should therefore not be selected in isolation.

11.9 Motors and Drives

Motors are among the most common electrical components in machinery.

Their assessment must go beyond basic electrical ratings.

Relevant considerations may include:

• overload,
• overheating,
• unexpected start-up,
• braking behavior,
• run-down time,
• direction of rotation,
• drive faults,
• loss of control functions.

Modern machinery increasingly uses variable-speed drives and servo drives.

This introduces additional considerations such as:

• DC-link voltage,
• stored energy,
• electromagnetic disturbances,
• safety-related drive functions,
• regenerative energy,
• braking energy.

Electrical safety and EMC therefore need to be considered together.

11.10 Variable-Speed Drives and Electrical Safety

Variable-speed drives can have a significant impact on the machine’s safety concept.

A drive may:

• control motor speed,
• control torque,
• control braking,
• provide safety-related drive functions,
• regenerate energy.

At the same time, drives can introduce additional technical challenges, including:

• high switching frequencies,
• harmonics,
• conducted disturbances,
• leakage currents,
• electromagnetic fields,
• residual voltage in the DC link.

The electrical and EMC design therefore needs to account for the drive system as part of the complete machine.

11.11 Electromagnetic Compatibility

Electromagnetic compatibility (EMC) is another important aspect of modern machinery.

A machine must not only be sufficiently immune to electromagnetic disturbances.

It must also not generate electromagnetic disturbances at levels that prevent other equipment from operating as intended.

There are therefore two fundamental sides:

Emission

→ What electromagnetic disturbances does the machine generate?

Immunity

→ How does the machine behave when exposed to electromagnetic disturbances from its environment?

Both aspects need to be considered.

11.12 Why EMC Is Particularly Important for Machinery

Modern machines frequently contain:

• variable-speed drives,
• servo drives,
• switching power supplies,
• microcontrollers,
• PLCs,
• displays,
• Ethernet,
• industrial communication systems,
• wireless modules,
• sensors,
• actuators.

These components can generate electromagnetic disturbances or be sensitive to disturbances.

An EMC problem is therefore not necessarily just a production or quality problem.

In the worst case, electromagnetic interference can affect a safety-related function.

For example, interference could:

• distort a sensor signal,
• interrupt communication,
• affect an actuator,
• reset a controller,
• cause incorrect machine behavior.

EMC can therefore directly contribute to machine safety.

11.13 EMC Is Not Only a Laboratory Issue

A common mistake is to consider EMC only shortly before final compliance testing.

At that point, fundamental design decisions may already have been made.

Examples include:

• cable routing,
• grounding,
• cabinet layout,
• filtering,
• separation of signal and power cables,
• placement of power electronics.

Changing these elements late in the project can be expensive and time-consuming.

EMC should therefore be considered during the design phase rather than treated solely as a final laboratory test.

11.14 Typical Sources of EMC Disturbances

Typical sources include:

• variable-speed drives,
• motor cables,
• switching devices,
• relays,
• contactors,
• switching power supplies,
• DC/DC converters,
• high-speed digital circuits,
• communication interfaces,
• long cables,
• wireless systems.

Long cables can be particularly relevant because they can both radiate disturbances and pick them up.

11.15 Cables and Cable Routing

Cable routing can have a significant influence on the EMC performance of a machine.

Depending on the application, good design practice may include:

• separating power and signal cables,
• avoiding unnecessary parallel routing of sensitive and high-power cables,
• using suitable shielded cables,
• implementing cable shields correctly,
• keeping critical cable paths reasonably short,
• providing an appropriate grounding and bonding concept.

The exact implementation depends on the machine.

There is therefore no single universal EMC wiring rule that applies to every machine.

11.16 Control Cabinet Design and EMC

The control cabinet itself forms part of the EMC concept.

Relevant factors can include:

• component placement,
• separation of power and signal sections,
• cable routing,
• shield termination,
• grounding and bonding,
• filters,
• power supplies,
• variable-speed drives,
• cabinet openings,
• cable entries.

A component with excellent EMC characteristics can still cause problems when installed in an unsuitable system architecture.

11.17 EMC Testing

Depending on the machine and the applicable requirements, different EMC tests may be relevant.

Typical categories include:

Emission

Assessment of electromagnetic disturbances generated by the machine.

Immunity

Assessment of the machine’s behavior when exposed to electromagnetic disturbances.

Depending on the applicable standards and machine environment, testing can involve conducted or radiated phenomena and various immunity tests.

The specific test program must be determined based on:

• the machine,
• its intended environment,
• its electrical architecture,
• applicable legislation,
• applicable standards.

11.18 The Machine as a Complete System

One of the most important principles in EMC is the assessment of the complete machine.

A machine may contain components that individually have their own EMC compliance evidence.

That does not automatically mean that the fully assembled machine has identical EMC characteristics.

Integration can change:

• cable lengths,
• grounding,
• shielding,
• enclosure configuration,
• filtering,
• power supply,
• communication systems.

The EMC performance of the complete machine therefore has to be considered.

11.19 Components with Their Own CE Marking

Another common mistake is:

“All components have CE marking, so the machine does not need an EMC assessment.”

That conclusion is incorrect.

The CE marking of an individual component relates to that component under its applicable legislation and conditions.

When several components are integrated into a machine, the resulting system can create new interactions.

The manufacturer of the complete machine remains responsible for the conformity of the machine placed on the market or put into service.

11.20 External Power Supplies

External power supplies should also be considered as part of the overall design where they form part of the machine’s intended configuration.

Relevant parameters can include:

• input voltage,
• frequency,
• rated current,
• short-circuit conditions,
• protective conductor,
• leakage current,
• EMC characteristics,
• transient immunity.

The influence of the power supply on the complete machine should be assessed rather than considering the power supply as an entirely independent item.

11.21 Electrostatic Charging

Annex I of the Machinery Directive also contains specific requirements concerning static electricity.

Machinery must be designed and constructed so as to prevent or limit the build-up of potentially dangerous electrostatic charges or be equipped with means of discharging them.

This can be particularly relevant for machines handling:

• insulating materials,
• films,
• plastics,
• powders,
• fine materials,
• rapidly moving materials.

Electrostatic charging can:

• expose operators to shocks,
• interfere with electronic equipment,
• disturb production processes,
• create ignition hazards in certain environments.

The relevance depends strongly on the machine and its operating environment.

11.22 Voltage Disturbances and Power Quality

Machines can be exposed to various disturbances in their electrical supply.

Examples include:

• voltage transients,
• voltage dips,
• undervoltage,
• overvoltage,
• interruptions,
• switching disturbances.

The machine should be designed so that foreseeable disturbances do not result in dangerous conditions.

The behavior of safety-related functions is particularly important.

For example, a power disturbance should not cause a machine to enter an uncontrolled dangerous state.

11.23 Behavior After Power Failure

The behavior of the machine following loss and restoration of power should be deliberately defined.

Questions include:

• What happens when the supply voltage disappears?
• Which movements stop?
• Which energy remains stored?
• What happens when power returns?
• Is a manual reset required?
• Which operating mode is selected?
• Can a dangerous movement restart automatically?

This behavior should be addressed as part of the machine’s safety and control concept.

11.24 Electrical Equipment and Maintenance

Electrical safety also applies during maintenance and servicing.

Annex I requires, among other things, that setting and maintenance points be located outside danger zones where possible and that setting, maintenance, repair, cleaning and servicing operations can be carried out while the machinery is stopped. Where this is not technically possible, appropriate measures must be taken to ensure that such operations can be performed safely.

This leads to an important principle:

A machine that is safe during normal production is not automatically safe to maintain.

Electrical isolation, stored energy and access to electrical equipment therefore need to be considered during maintenance activities.

11.25 Electrical Documentation

The electrical design should be documented in a way that allows the final machine to be understood and verified.

Depending on the machine, documentation can include:

• circuit diagrams,
• wiring diagrams,
• terminal diagrams,
• control cabinet drawings,
• component lists,
• cable lists,
• identification systems,
• protective conductor concepts,
• protection-device specifications,
• drive parameters,
• control-system documentation,
• test records.

The documentation should correspond to the machine that was actually built.

A common problem is that changes are made during assembly but the electrical drawings are not updated afterwards.

11.26 Electrical Testing

Depending on the machine and the applicable standards, various tests may be appropriate.

Examples include:

• protective conductor testing,
• insulation testing,
• voltage testing,
• functional testing,
• verification of protective measures,
• safety-function testing,
• EMC testing.

The exact test program depends on:

• the machine,
• its electrical architecture,
• the applicable standards,
• the identified risks.

Test documentation should provide sufficient information to establish what was tested, how it was tested and what the result was.

11.27 Common Mistakes

Mistake 1 – Considering electrical safety too late

The electrical system is addressed only after the mechanical design has been completed.

Better approach: integrate electrical safety into the design from the beginning.

Mistake 2 – Treating component CE markings as proof of machine compliance

Individual components have CE markings and are assembled into a machine. The manufacturer then assumes that the complete machine is automatically compliant.

This is not sufficient.

Mistake 3 – Treating EMC as a final laboratory problem

Cable routing, grounding and cabinet design are only considered when the machine is sent for final testing.

This can result in expensive redesigns.

Mistake 4 – Ignoring stored energy

The machine is switched off, but capacitors, DC links or other energy-storage systems remain hazardous.

Mistake 5 – Not checking power-restoration behavior

The machine stops correctly during a power failure but automatically resumes a dangerous operation when power returns.

Mistake 6 – Electrical documentation does not match the machine

Changes made during assembly are not reflected in the final electrical documentation.

Mistake 7 – Separating safety and EMC completely

EMC is treated as a purely laboratory issue even though electromagnetic disturbances can affect safety-related control functions.

11.28 A Practical Workflow

A structured approach to electrical compliance can look like this:

Step 1 – Identify energy sources

Identify all electrical and other relevant energy sources.

Step 2 – Identify electrical hazards

Assess electric shock, short circuits, overheating, stored energy and other relevant hazards.

Step 3 – Define the electrical architecture

Define the power supply, control architecture, drives and protection concept.

Step 4 – Identify applicable standards

For example, EN 60204-1 and additional product- or machine-specific standards.

Step 5 – Implement protective measures

Implement protective conductors, insulation, isolation, overcurrent protection and other necessary measures.

Step 6 – Integrate safety functions

Integrate the electrical equipment with the safety functions identified during the risk assessment.

Step 7 – Develop the EMC concept

Consider grounding, bonding, cable routing, shielding, filtering, cabinet design and component selection.

Step 8 – Assess shutdown and stored energy

Verify that shutdown does not leave uncontrolled hazardous conditions.

Step 9 – Perform the necessary tests

Perform electrical safety tests and, where applicable, EMC testing.

Step 10 – Finalize the documentation

Ensure that the electrical documentation accurately reflects the final machine.

11.29 Example: Automated Machine with Servo Drives

Consider an automated machine with several servo axes.

The machine contains:

• mains supply,
• main disconnect,
• control cabinet,
• servo drives,
• servo motors,
• PLC,
• safety controller,
• Ethernet communication,
• sensors.

Several areas have to be addressed together.

Electrical safety

• protection against electric shock,
• protective conductors,
• overcurrent protection,
• isolation and disconnection.

Functional safety

• safe drive functions,
• guard monitoring,
• emergency stop,
• prevention of unexpected movement.

EMC

• motor cables,
• shielding,
• servo drives,
• communication cables,
• control cabinet design.

Stored energy

• DC links,
• capacitors,
• mechanical energy in the axes.

Documentation

• circuit diagrams,
• safety functions,
• test results,
• drive parameters,
• technical documentation.

This illustrates why electrical safety, EMC and functional safety cannot always be treated as independent compliance activities.

11.30 The Key Principle

When assessing the electrical equipment of machinery, the question should not simply be:

“Are all electrical components compliant with their respective standards?”

The more important question is:

“Is the electrical equipment, as integrated into the complete machine, safe and compliant with the requirements applicable to that machine?”

This system-level perspective is essential.

A machine is not simply a collection of independently compliant components. The integration of those components creates the actual product.

11.31 Summary

The electrical equipment of machinery should be treated as an integral part of the machine’s overall safety and conformity concept.

Particularly important areas include:

• electrical hazards,
• power supply,
• protection against electric shock,
• protective conductors and bonding,
• overcurrent and short-circuit protection,
• stored energy,
• drives,
• behavior after power failure,
• electromagnetic compatibility,
• electrostatic charging,
• maintenance and servicing,
• electrical testing,
• complete electrical documentation.

EN 60204-1 is an important technical standard for the electrical equipment of machines. However, the applicable standards must always be determined for the specific machine and its intended use.

The Machinery Directive requires the machine and its relevant hazards to be considered as a whole.

The key principle is:

Electrical safety, EMC and machine safety should be treated as interconnected aspects of the same system — not as three completely separate testing activities.

Official Sources

• EUR-Lex – Directive 2006/42/EC on machinery
• European Commission – Machinery
• European Commission – Harmonised standards for machinery
• Commission Implementing Decision (EU) 2023/1586 – Harmonised standards for machinery

Chapter 12: Conformity Assessment and CE Marking

Conformity assessment is the formal process through which the manufacturer demonstrates that machinery complies with the applicable requirements of the Machinery Directive.

It is much more than simply applying the CE marking.

The CE marking is the final visible result of a process that includes determining the applicable legal framework, identifying and assessing risks, designing appropriate protective measures, applying relevant standards, preparing the technical file and, depending on the machinery, applying the appropriate conformity assessment procedure.

The fundamental principle is:

First establish conformity — then affix the CE marking.

Directive 2006/42/EC establishes different conformity assessment procedures. The procedure depends in particular on the type of machinery and on whether the machinery falls within one of the categories listed in Annex IV. (EUR-Lex)

12.1 What Is Conformity Assessment?

Conformity assessment is the process used to establish and document that a product satisfies the applicable legal requirements.

For machinery, this primarily means assessing whether the machinery complies with the relevant essential health and safety requirements of Annex I.

The manufacturer must therefore determine:

• Which legislation applies?
• Which requirements are relevant?
• Which hazards exist?
• Which protective measures have been implemented?
• Which standards are applicable?
• Which tests or verifications are necessary?
• Which conformity assessment procedure must be used?
• Which technical documentation must be prepared?

Conformity assessment is therefore closely connected to the design and construction of the machinery.

It should not be treated as something that begins only after the machine has been completed.

12.2 Who Is Responsible for Conformity Assessment?

The manufacturer is fundamentally responsible for ensuring conformity.

The manufacturer must ensure that the machinery:

• complies with the applicable requirements,
• has undergone the appropriate conformity assessment procedure,
• has the required technical documentation,
• is supplied with the required instructions,
• is accompanied by the required EC Declaration of Conformity,
• is correctly CE marked.

The manufacturer may use external specialists, laboratories or other organisations to perform individual tasks.

However, using an external organisation does not automatically transfer the manufacturer’s legal responsibility for the conformity of the machinery.

This distinction between:

technical support

and

legal manufacturer responsibility

is extremely important.

12.3 Conformity Assessment Does Not Start with the CE Marking

A common mistake is to start the process with the question:

“How do we get the CE mark?”

That is the wrong starting point.

A more appropriate sequence is:

1. Identify the product
2. Determine its scope and intended use
3. Identify the applicable legislation
4. Define the machinery and its intended use
5. Identify hazards
6. Perform the risk assessment
7. Define protective measures
8. Identify relevant standards
9. Design and verify the machinery
10. Perform the required tests
11. Prepare the technical file
12. Apply the appropriate conformity assessment procedure
13. Draw up the EC Declaration of Conformity
14. Affix the CE marking

The CE marking is therefore the result of the conformity assessment process, not its starting point.

Article 5 of the Machinery Directive explicitly requires the manufacturer, before placing machinery on the market or putting it into service, to ensure compliance with the essential health and safety requirements, make the technical file available, provide the necessary information, carry out the appropriate conformity assessment procedure, draw up the EC Declaration of Conformity and affix the CE marking. (EUR-Lex)

12.4 The Different Conformity Assessment Procedures

The Machinery Directive provides different conformity assessment procedures.

The procedure depends in particular on whether the machinery is listed in Annex IV.

For machinery that is not listed in Annex IV, the Directive provides for the procedure of internal checks on the manufacture of machinery under Annex VIII.

For machinery listed in Annex IV, additional conformity assessment routes may apply.

Depending on the circumstances, these include:

• internal checks on the manufacture of machinery,
• EC type-examination combined with internal checks,
• the full quality assurance procedure.

The exact route depends on the machinery, the use of harmonised standards and whether those standards cover all relevant essential health and safety requirements. (EUR-Lex)

12.5 Machinery Listed in Annex IV

Annex IV is particularly important for conformity assessment.

It contains categories of machinery for which special conformity assessment procedures are provided because of the specific risks associated with those machines.

Examples include certain:

• circular saws,
• presses,
• lifting platforms,
• portable cartridge-operated fixing and other impact machinery,
• woodworking machinery,
• underground working machinery,
• certain safety components.

The complete list must be checked against Annex IV of the Machinery Directive rather than relying on a general product description. (EUR-Lex)

This is important because classification should not be based simply on what the manufacturer calls the machine.

Two machines that appear similar may be subject to different requirements because of their technical characteristics, function or intended use.

12.6 Why Annex IV Classification Matters

Being classified as Annex IV machinery can significantly affect the conformity assessment process.

In particular, the involvement of a Notified Body may become necessary depending on the applicable conformity assessment route.

This does not mean that every machine requires a Notified Body.

The relevant question is:

Which conformity assessment procedure does the Machinery Directive prescribe for this particular machine?

12.7 Internal Checks on the Manufacture of Machinery

For machinery that is not covered by Annex IV, the Machinery Directive generally provides for an internal conformity assessment procedure.

Under this approach, the manufacturer itself ensures and documents that the machinery complies with the applicable requirements.

This does not mean that no testing is required.

It means that the conformity assessment can generally be carried out without mandatory involvement of a Notified Body.

The manufacturer must nevertheless have adequate evidence supporting conformity.

Depending on the machinery, this may include:

• calculations,
• design documentation,
• risk assessment,
• test reports,
• measurements,
• functional tests,
• applied standards,
• technical drawings,
• circuit diagrams.

12.8 The Role of Harmonised Standards

Harmonised European standards play an important role in the conformity assessment process.

Where a relevant harmonised standard has been applied and its reference has been published in the Official Journal of the European Union, machinery manufactured in accordance with that standard benefits from a presumption of conformity with the essential health and safety requirements covered by the standard. (EUR-Lex)

This does not mean:

“The standard was applied, therefore everything is automatically compliant.”

The presumption applies to the requirements covered by the relevant harmonised standard and within its scope.

The manufacturer therefore needs to understand:

• which standard is being used,
• what its scope is,
• which requirements it addresses,
• whether all relevant requirements are covered,
• whether the standard has the appropriate harmonised status.

The European Commission publishes information concerning harmonised standards for machinery.

12.9 A Standard Is Not a Substitute for the Risk Assessment

A particularly common mistake is:

“We applied EN XYZ, so the machine is safe.”

That conclusion is too simplistic.

The risk assessment remains a fundamental part of the process.

A standard can provide technical requirements, design principles and test methods.

It cannot automatically account for every characteristic of every individual machine.

A particular machine may have:

• unusual operating modes,
• unique hazards,
• unusual interfaces,
• special materials,
• unusual environmental conditions,
• specific foreseeable misuse.

These aspects still need to be considered.

12.10 What If No Suitable Harmonised Standard Exists?

Not every machine has one harmonised standard that covers all relevant requirements.

The manufacturer can nevertheless perform a conformity assessment.

The manufacturer must then demonstrate through appropriate technical means that the applicable essential health and safety requirements have been fulfilled.

Depending on the situation, this may involve:

• other European standards,
• international standards,
• national technical standards,
• technical specifications,
• engineering calculations,
• testing,
• manufacturer-specific technical solutions.

The objective should not be to produce the longest possible list of standards.

The objective should be to demonstrate that the relevant requirements have actually been addressed.

12.11 The Technical File as Evidence

The technical file is a central element of the conformity assessment process.

It must demonstrate that the machinery complies with the requirements of the Machinery Directive and must cover its design, manufacture and operation to the extent necessary for that assessment. (EUR-Lex)

Depending on the machinery, it can include:

• general description,
• overall drawings,
• control circuit drawings,
• detailed drawings,
• calculations,
• test results,
• certificates,
• risk assessment documentation,
• applied standards,
• technical specifications,
• instructions,
• EC Declaration of Conformity.

The technical file must not simply exist.

It should correspond to the machine that was actually manufactured.

12.12 Testing and Verification

Depending on the machine and the applicable requirements, conformity assessment may require different types of testing and verification.

These may include:

Mechanical testing

• strength,
• stability,
• movement,
• protective distances.

Electrical testing

• protective conductor testing,
• insulation testing,
• electrical protective measures,
• functional testing.

Safety functions

• emergency stop,
• guard monitoring,
• light curtains,
• safe drive functions,
• interlocks.

EMC

• emissions,
• immunity.

Other product-specific testing

• noise,
• vibration,
• pressure,
• temperature,
• radiation,
• ergonomic factors.

The required test program should be derived from the specific machinery, the risk assessment and the applicable standards.

12.13 What Happens If a Machine Fails a Test?

A failed test does not necessarily mean that the entire project has failed.

It indicates that a particular requirement or technical characteristic may not have been adequately addressed.

For example, an EMC test may show that:

• filtering is insufficient,
• cables are incorrectly routed,
• shielding needs improvement,
• a component is unsuitable.

A safety test may reveal that:

• a stopping time is too long,
• a protective distance is insufficient,
• a safety function has not been implemented correctly.

The underlying cause should be investigated.

The manufacturer can then:

1. implement the necessary technical changes,
2. verify the modification,
3. repeat the relevant testing,
4. update the technical documentation.

12.14 The EC Declaration of Conformity

Once the appropriate conformity assessment has been completed, the manufacturer must draw up the EC Declaration of Conformity.

The declaration confirms that the machinery complies with the applicable requirements of the Machinery Directive and, where relevant, other applicable EU legislation.

The Machinery Directive specifies the information that the declaration must contain.

This includes, among other things:

• the name and full address of the manufacturer,
• identification and description of the machinery,
• where applicable, the name and address of the person authorised to compile the technical file,
• where applicable, details of the Notified Body,
• where applicable, references to standards,
• a declaration of compliance with the relevant requirements,
• place and date,
• identity and signature of the authorised person. (EUR-Lex)

12.15 The Declaration of Conformity Is Not a Test Report

These documents are sometimes confused in practice.

A test report documents the results of a particular test.

An EC Declaration of Conformity is the manufacturer’s formal declaration that the machinery complies with the applicable requirements.

For example, a laboratory may issue an EMC test report.

The EC Declaration of Conformity is issued by the manufacturer or the party legally responsible for the machinery.

A test report may be supporting evidence for the conformity assessment, but it is not itself the conformity declaration.

12.16 The CE Marking

The CE marking is affixed only after the required conformity assessment steps have been completed.

The CE marking represents the manufacturer’s declaration that the machinery complies with the applicable EU requirements.

It is therefore not:

• a quality mark,
• a test seal,
• a laboratory certificate,
• an EU approval certificate.

It is a legal conformity marking.

The Machinery Directive also specifies requirements concerning the form and placement of the CE marking. (EUR-Lex)

12.17 CE Does Not Mean “Approved by the EU”

A common misconception is:

“The machine has CE, so the European Union has tested and approved it.”

That is not what the CE marking generally means.

For many machines, the manufacturer performs the conformity assessment itself.

Only certain machinery and conformity assessment procedures require mandatory involvement of a Notified Body.

CE marking should therefore not be confused with a government product approval.

12.18 When Must a Notified Body Be Involved?

The answer depends on the specific conformity assessment procedure.

For certain Annex IV machines, a Notified Body may be required.

For example, it may be involved in:

• EC type-examination,
• full quality assurance.

Whether its involvement is mandatory depends on the specific machine and the applicable conformity assessment route. (EUR-Lex)

12.19 A Notified Body Is Not Simply a Test Laboratory

These terms should also not be used interchangeably.

A test laboratory may perform technical tests.

A Notified Body, however, is an organisation that has been formally notified by a Member State for specified conformity assessment activities.

An organisation may perform several different roles depending on its accreditation and notification.

Therefore, the relevant question is not simply:

“Is this company a Notified Body?”

The more precise question is:

“For which legislation, conformity assessment procedures and machinery categories is this organisation actually notified?”

The European Commission provides the NANDO database for identifying notified bodies and their notification scopes.

12.20 When Is the CE Marking Applied?

The CE marking should not be applied first and justified afterwards.

The process should work in the opposite direction.

First:

• applicable requirements are identified,
• risks are assessed,
• protective measures are implemented,
• conformity is assessed,
• supporting evidence is created.

Only then is the CE marking affixed.

12.21 What Should Be Completed Before CE Marking?

Before affixing the CE marking, the manufacturer should ensure that, as applicable:

• the machinery has been correctly classified,
• all applicable legislation has been identified,
• the risk assessment has been completed,
• relevant essential health and safety requirements have been assessed,
• required protective measures have been implemented,
• relevant standards have been evaluated,
• required tests have been completed,
• the technical file has been prepared,
• the instructions are complete,
• the EC Declaration of Conformity has been prepared and signed,
• the required conformity assessment procedure has been completed,
• the CE marking is applied correctly.

The exact sequence of individual engineering activities may vary from project to project.

12.22 What Happens After CE Marking?

The manufacturer’s responsibilities do not necessarily end once the CE marking has been applied.

After placing machinery on the market or putting it into service, manufacturers may become aware of:

• safety problems,
• complaints,
• accidents,
• design defects,
• new information about risks,
• changes affecting the product,
• relevant regulatory developments.

Such information may require further investigation or corrective action.

A robust compliance process should therefore consider the entire product lifecycle rather than treating CE marking as the final technical activity.

12.23 Changes to Machinery That Is Already Conforming

An important question is what happens when a machine is modified after its conformity assessment has been completed.

Not every modification automatically requires a new conformity assessment.

The manufacturer or responsible party should assess whether the modification:

• creates new risks,
• changes existing risks,
• affects protective measures,
• changes safety functions,
• changes the intended use,
• changes relevant operating characteristics.

Examples may include:

• changing a drive,
• changing a guard,
• modifying the control system,
• increasing machine speed,
• changing the intended use,
• adding new functions.

A modification should therefore not simply be classified as a “technical change.”

The relevant question is:

Does the modification affect the safety or conformity of the machinery?

12.24 Common Conformity Assessment Mistakes

Mistake 1 – Treating CE as a certificate

The CE marking is treated as though it were a certificate issued by an authority.

Problem: The CE marking is generally the manufacturer’s conformity marking.

Mistake 2 – Assuming every machine requires a Notified Body

The manufacturer assumes that external certification is mandatory for every machine.

Problem: This depends on the applicable conformity assessment procedure.

Mistake 3 – Creating a standards list instead of performing a conformity assessment

A long list of standards is created without determining which requirements are actually addressed.

Problem: The number of standards does not demonstrate conformity.

Mistake 4 – Confusing a test report with conformity

A successful EMC or safety test is treated as proof that the complete machine is compliant.

Problem: Individual tests do not automatically cover all applicable requirements.

Mistake 5 – Preparing the technical file only at the end

The technical documentation is assembled after the machine has already been designed and built.

Problem: Important evidence may be missing or difficult to reconstruct.

Mistake 6 – Failing to reassess modifications

Changes are made to the machine without assessing their impact on the risk assessment and conformity.

Problem: A machine that was originally conforming may acquire new risks through modification.

12.25 Practical Conformity Assessment Checklist

Before completing the conformity assessment, the manufacturer should verify at least the following:

Product

• Is the machinery clearly identified?
• Is the intended use defined?
• Have reasonably foreseeable misuses been considered?

Legal framework

• Have all applicable EU legal acts been identified?
• Is the Machinery Directive correctly applied?
• Have other potentially applicable requirements been considered?

Risks

• Is the risk assessment complete?
• Have all relevant hazards been assessed?
• Have protective measures been implemented?

Standards

• Have relevant harmonised standards been identified?
• Has their current status been checked?
• Is it documented which requirements they cover?

Conformity assessment

• Which procedure applies?
• Is the machinery listed in Annex IV?
• Is a Notified Body required?

Evidence

• Are test reports available?
• Are calculations and technical evidence available?
• Does the technical file correspond to the actual machine?

Documentation

• Are the instructions complete?
• Has the EC Declaration of Conformity been prepared?
• Does it contain all required information?

Marking

• Is the CE marking correctly applied?
• Are any other required markings present?

12.26 The Critical Connection Between the Different Steps

Conformity assessment should not be treated as an isolated administrative task performed at the end of a machinery project.

It is the result of several interconnected processes:

Product definition

↓

Risk assessment

↓

Protective measures

↓

Technical design

↓

Application of standards

↓

Verification and testing

↓

Technical documentation

↓

Conformity assessment

↓

EC Declaration of Conformity

↓

CE marking

The complete chain should be traceable.

For example, if a protective measure is required by the risk assessment, it should be reflected in the technical design.

If a technical solution is justified through a standard, it should be possible to identify which requirement the standard addresses.

If testing is required, the result should be documented.

Once these elements have been brought together, the manufacturer can complete the conformity assessment and issue the EC Declaration of Conformity.

12.27 Summary

Conformity assessment of machinery is a structured process, not a single test.

The manufacturer must, in particular:

• correctly classify the machinery,
• identify the applicable legislation,
• identify the relevant requirements,
• perform a risk assessment,
• implement appropriate protective measures,
• identify relevant standards,
• apply the appropriate conformity assessment procedure,
• prepare the technical file,
• perform the necessary tests and verifications,
• issue the EC Declaration of Conformity,
• and finally affix the CE marking.

Particular attention should be paid to whether the machinery falls under Annex IV, because this can affect the available conformity assessment procedures and the potential involvement of a Notified Body. (EUR-Lex)

The key principle is:

CE marking is not proof that a single test has been passed. It is the result of a complete conformity assessment process for which the manufacturer assumes responsibility.

Important Regulatory Transition

Because this article is specifically about the Machinery Directive, one important date should be kept visible in the final ScopeRight article.

The current legal framework is transitioning from Directive 2006/42/EC to Regulation (EU) 2023/1230 on machinery. The new Machinery Regulation will apply from 20 January 2027, at which point it repeals Directive 2006/42/EC. Certain provisions of the Regulation already apply earlier. (EUR-Lex)

This means a current article should distinguish clearly between:

• Machinery Directive 2006/42/EC — current framework during the transition, and
• Machinery Regulation (EU) 2023/1230 — the future framework applicable from 20 January 2027.

This distinction is particularly important when discussing conformity assessment because the new Regulation introduces a different structure for conformity assessment procedures and categories of machinery. (EUR-Lex)

Official Sources

• EUR-Lex – Directive 2006/42/EC on machinery
• European Commission – Machinery
• European Commission – Harmonised standards for machinery
• EUR-Lex – Machinery Regulation (EU) 2023/1230
• European Commission / EUR-Lex – Machinery safety requirements and transition to the new Regulation

Chapter 13: Harmonised Standards and Their Importance

Harmonised standards are one of the most important practical tools available to manufacturers when demonstrating compliance with the Machinery Directive.

They translate many of the general safety principles of the legislation into more specific technical approaches.

However, harmonised standards are often misunderstood.

A manufacturer may have a long list of standards but still have an incomplete conformity assessment. Conversely, the absence of a specific harmonised standard does not mean that a machine cannot be placed on the EU market.

The key is understanding what a harmonised standard is, what legal effect it has, and how it should be used within the overall conformity assessment process.

13.1 What Is a Harmonised Standard?

A harmonised standard is a European standard developed by a recognised European Standardisation Organisation — CEN, CENELEC or ETSI — following a request from the European Commission. Manufacturers and other economic operators can use harmonised standards to demonstrate compliance with relevant EU legislation. (IMIES)

For machinery, harmonised standards are developed in support of the Machinery Directive 2006/42/EC.

The European Commission maintains the official information on harmonised standards and their publication in the Official Journal of the European Union (OJEU). (IMIES)

This distinction is important:

A European standard is not automatically a harmonised standard for the purposes of EU legislation.

A standard becomes relevant as a harmonised standard for the relevant legislation when its reference has been published in the OJEU.

13.2 Are Standards Mandatory?

Generally, no.

The Machinery Directive establishes mandatory essential health and safety requirements. The use of harmonised standards is, in principle, voluntary.

The manufacturer can use other technical solutions to demonstrate that the essential health and safety requirements have been fulfilled.

However, harmonised standards provide an important legal advantage.

Where a relevant harmonised standard is correctly applied, it can provide a presumption of conformity with the essential health and safety requirements covered by that standard.

This is why harmonised standards are so important even though their use is generally voluntary.

The European Commission describes the Machinery Directive as combining mandatory essential health and safety requirements with voluntary harmonised standards reflecting the state of the art. (IMIES)

13.3 Presumption of Conformity

The concept of presumption of conformity is one of the most important reasons for using harmonised standards.

If a manufacturer applies a relevant harmonised standard correctly, the manufacturer can benefit from the presumption that the corresponding requirements covered by that standard have been fulfilled.

But the presumption has limits.

It does not mean:

“The machine complies with the Machinery Directive simply because a harmonised standard appears in the technical file.”

The manufacturer must determine:

• whether the standard is actually relevant,
• whether the machine falls within its scope,
• whether the standard is harmonised under the Machinery Directive,
• whether its reference has been published in the OJEU,
• whether any restrictions apply,
• whether the standard actually covers the requirements being claimed.

The current Commission Implementing Decision (EU) 2023/1586 contains the published references of harmonised standards supporting Directive 2006/42/EC. Its consolidated version also identifies standards whose references are published or maintained with restrictions. (EUR-Lex)

13.4 Type A, Type B and Type C Standards

Machinery standards are commonly structured into three categories.

Type A standards – Basic safety standards

Type A standards address fundamental concepts, principles and general aspects applicable to machinery.

A key example is:

EN ISO 12100 – Safety of machinery – General principles for design – Risk assessment and risk reduction.

Type A standards establish broad principles rather than detailed requirements for a particular type of machine.

They are therefore highly relevant across many machinery projects.

Type B standards – Generic safety aspects

Type B standards address particular safety aspects or types of safeguards that can apply to a wide range of machines.

Examples include standards dealing with:

• safety distances,
• prevention of unexpected start-up,
• pressure-sensitive protective devices,
• interlocking devices,
• safety-related control systems,
• electrical equipment,
• noise measurement.

Type B standards can therefore provide detailed solutions for specific safety functions or hazards.

Type C standards – Machine-specific standards

Type C standards apply to a particular machine or group of machines.

They can contain detailed safety requirements for that specific machine category.

For example, a Type C standard may specify:

• particular guarding requirements,
• specific safety distances,
• machine-specific control requirements,
• particular testing procedures,
• specific residual risk information.

Where a relevant Type C standard exists, it can be particularly valuable because it addresses the specific machinery category rather than only a general safety principle.

The relationship between different standards should nevertheless be assessed carefully rather than simply assuming that the most specific standard automatically resolves every compliance issue.

13.5 How to Find Relevant Standards

Selecting standards should be treated as a structured activity.

A practical approach is:

Step 1 – Identify the machine

Determine exactly what the machine does.

For example:

• automated packaging machine,
• industrial robot cell,
• CNC machine,
• conveyor,
• press,
• woodworking machine,
• lifting machine.

Step 2 – Identify the hazards

Use the risk assessment to determine the relevant hazards.

These may include:

• mechanical hazards,
• electrical hazards,
• thermal hazards,
• noise,
• vibration,
• radiation,
• ergonomic hazards,
• control-system failures,
• unexpected start-up.

Step 3 – Search for machine-specific standards

First determine whether a relevant Type C standard exists.

Step 4 – Identify applicable Type B standards

Then determine which generic safety standards address the remaining hazards or safety functions.

Step 5 – Apply relevant Type A principles

Finally, ensure that the general machinery safety principles and risk reduction methodology are properly addressed.

Step 6 – Verify the legal status

This step is essential.

The manufacturer should verify whether the standard is actually listed as a harmonised standard supporting the Machinery Directive and whether any restrictions apply.

13.6 How to Check the Status of a Harmonised Standard

The title of a standard is not enough.

A manufacturer should not rely solely on:

• a standards catalogue,
• an old compliance report,
• a laboratory quotation,
• a supplier statement,
• an internet search result.

The legal status should be checked against the official EU information.

The European Commission provides a dedicated harmonised standards database and information on publications in the OJEU. (IMIES)

For machinery, Commission Implementing Decision (EU) 2023/1586 is particularly important because it lists the harmonised standards developed in support of Directive 2006/42/EC. The decision has subsequently been amended, and the consolidated version should therefore be checked rather than relying on the original 2023 publication alone. (EUR-Lex)

This is particularly important for standards that have been:

• replaced,
• withdrawn,
• amended,
• published with restrictions,
• or assigned a future withdrawal date.

13.7 Standards with Restrictions or Without Presumption of Conformity

A particularly important point is that publication of a standard does not necessarily mean that every requirement of the standard provides an unrestricted presumption of conformity.

The European Commission can publish a harmonised standard with a restriction.

The current machinery harmonised-standard decision explicitly identifies standards whose references are published or maintained in the OJEU with restrictions. (EUR-Lex)

The Commission also maintains information concerning formal objections against harmonised standards.

A Member State or the European Parliament can raise an objection where a harmonised standard does not entirely satisfy the requirements it is intended to cover. Following the applicable procedure, the Commission can maintain, restrict or withdraw the publication of the reference. (IMIES)

This is one reason why simply writing a standard number into a technical file is insufficient.

The manufacturer should know its current legal status.

13.8 What If No Suitable Harmonised Standard Exists?

A machine can still comply with the Machinery Directive even if there is no suitable harmonised standard.

The Machinery Directive does not make the existence of a harmonised standard a prerequisite for placing machinery on the EU market.

The manufacturer must instead demonstrate that the applicable essential health and safety requirements have been fulfilled using appropriate technical solutions and evidence.

This may involve:

• non-harmonised European standards,
• international standards,
• national standards,
• technical specifications,
• engineering calculations,
• testing,
• design analysis,
• manufacturer-specific technical solutions.

The absence of a harmonised standard therefore means:

The manufacturer may have less benefit from the presumption of conformity — not that compliance is impossible.

13.9 What to Do When a Standard Is New or Revised?

Standards change.

A manufacturer may therefore encounter situations where:

• a new edition has been published,
• an old edition remains referenced in the OJEU,
• a new edition has not yet been harmonised,
• the old edition is approaching withdrawal,
• a standard has been amended,
• or a reference has been published with restrictions.

This creates an important distinction between:

the latest technical standard

and

the currently harmonised standard providing presumption of conformity under the legislation.

They are not necessarily the same document.

A manufacturer should therefore avoid automatically replacing every standard in its compliance program with the newest edition.

Instead, the manufacturer should assess:

1. Which edition is currently applicable?
2. Which edition is referenced in the OJEU?
3. Is the reference unrestricted?
4. Has a withdrawal date been established?
5. What technical changes exist between editions?
6. Does the change affect the machine’s conformity?

The answer may require both a technical and a regulatory assessment.

13.10 Standards and Risk Assessment – Which Comes First?

The risk assessment and standards selection are closely connected.

They should not be treated as completely independent processes.

A practical sequence is:

Machine definition

↓

Hazard identification

↓

Risk assessment

↓

Identification of applicable standards

↓

Selection of protective measures

↓

Verification

However, the process is iterative.

Standards can help identify hazards and appropriate protective measures.

The risk assessment can reveal that additional standards need to be considered.

For example, the risk assessment may identify an unexpected-start hazard.

The manufacturer can then use an appropriate standard addressing prevention of unexpected start-up as part of the technical solution.

The standard therefore supports the risk reduction process.

It does not replace it.

13.11 Common Mistakes When Selecting Standards

Mistake 1 – Assuming every EN standard is harmonised

An EN standard may be technically relevant without being a harmonised standard supporting the Machinery Directive.

Better approach: Check the official OJEU status.

Mistake 2 – Using an old standards list

A standards list prepared several years ago may no longer reflect the current legal situation.

Better approach: Check the current Commission implementing decision and applicable amendments.

Mistake 3 – Assuming the newest edition automatically gives presumption of conformity

The newest edition of a standard is not necessarily the edition currently referenced in the OJEU.

Better approach: Separate the technical status of the standard from its legal harmonisation status.

Mistake 4 – Assuming one standard covers the entire machine

A machine may require several standards covering different hazards and safety functions.

Better approach: Build the standards selection from the machine’s hazards and applicable requirements.

Mistake 5 – Treating a standards list as a risk assessment

A document containing twenty standards does not demonstrate that the machine’s risks have been adequately assessed.

Better approach: Maintain a clear connection between hazards, requirements, protective measures, standards and verification.

Mistake 6 – Ignoring restrictions

A manufacturer may rely on a harmonised standard without noticing that its OJEU publication is subject to a restriction.

Better approach: Check the official status and any restrictions before relying on the presumption of conformity.

13.12 A Practical Standards Selection Workflow

A robust standards process can be structured as follows:

Step	Question
1	What exactly is the machine?
2	What is its intended use?
3	What hazards have been identified?
4	Is there a relevant Type C standard?
5	Which Type B standards address the identified hazards?
6	Which Type A principles apply?
7	Are additional standards needed for electrical, EMC, control-system or other aspects?
8	Which standards are harmonised under the Machinery Directive?
9	What is their current OJEU status?
10	Are any restrictions applicable?
11	Which requirements are covered by each standard?
12	How will conformity with those requirements be verified?

The result should not simply be a list of standard numbers.

It should form a traceable compliance structure.

For example:

Hazard

→ unexpected start-up

Requirement

→ prevent unintended energisation

Technical solution

→ isolation and prevention of restart

Applicable standard

→ relevant harmonised standard

Verification

→ functional test

Evidence

→ test record in the technical documentation

This approach is far more useful than a standards list without context.

13.13 Standards Are Tools — Not the Compliance Strategy

The most important principle of this chapter is that standards should support the compliance strategy rather than become the strategy themselves.

A strong machinery compliance process connects:

Legislation

→ defines the mandatory requirements

Risk assessment

→ identifies the hazards and determines the necessary risk reduction

Standards

→ provide recognised technical approaches

Design

→ implements the protective measures

Verification

→ demonstrates that the measures work

Technical documentation

→ records the evidence

This relationship makes the conformity assessment defensible and traceable.

13.14 Summary

Harmonised standards are voluntary technical tools that can provide significant value during machinery conformity assessment.

Their importance comes primarily from the presumption of conformity that can arise when the applicable harmonised standards are correctly applied.

However, manufacturers must distinguish carefully between:

• a European standard,
• a harmonised standard,
• the latest edition of a standard,
• a standard whose reference is published in the OJEU,
• and a harmonised standard published with restrictions.

For machinery under Directive 2006/42/EC, the official EU sources should be used to verify the current status of harmonised standards. The European Commission’s current machinery standards information and Commission Implementing Decision (EU) 2023/1586 are key references. (IMIES)

The practical rule is:

Do not ask only, “Which standards apply to this machine?” Ask instead, “Which requirements do we need to fulfil, which standards address them, what is the legal status of those standards, and how will we demonstrate conformity?”

That distinction is what turns standards selection from a document exercise into an effective compliance process.

Chapter 14: Technical Documentation

Technical documentation is one of the central elements of machinery compliance.

It is not merely a collection of drawings, test reports and certificates. It should provide a traceable explanation of how the manufacturer determined that the machinery complies with the applicable requirements of the Machinery Directive.

The Machinery Directive requires the technical documentation to cover the design, manufacture and operation of the machinery to the extent necessary for the conformity assessment. The specific requirements are set out primarily in Annex VII, Part A.

Good technical documentation should therefore answer three fundamental questions:

What was built?
Which risks and requirements were considered?
What evidence demonstrates that the machinery meets those requirements?

14.1 Why Is Technical Documentation Required?

Before placing machinery on the market or putting it into service, the manufacturer must, among other things, ensure that the technical documentation is available. This is explicitly included among the manufacturer’s obligations under Article 5 of the Machinery Directive.

Technical documentation serves several purposes.

Evidence for Authorities

The competent national authorities may request the technical documentation to assess whether machinery complies with the applicable requirements.

The manufacturer must therefore be able to make it available within an appropriate period.

Internal Evidence

The documentation also enables the manufacturer itself to determine:

• which design was assessed,
• which risks were identified,
• which protective measures were implemented,
• which standards were applied,
• which tests were performed,
• which residual risks remain.

Basis for Modifications

Good technical documentation becomes particularly valuable when machinery is modified later.

Without a clearly documented baseline, it can be difficult to determine whether a modification affects the machinery’s conformity.

14.2 Content of the Technical Documentation

Annex VII, Part A of the Machinery Directive specifies the principal elements of the technical documentation.

These include, among other things:

• a general description of the machinery,
• overall drawings,
• drawings of control circuits,
• detailed drawings,
• calculations,
• test results,
• certificates where relevant,
• documentation of the risk assessment,
• applied standards and technical specifications,
• technical reports,
• instructions,
• documentation relating to incorporated partly completed machinery where applicable,
• declarations of conformity for relevant incorporated products where applicable,
• a copy of the EC Declaration of Conformity,
• and, for series production, internal measures used to ensure continuing conformity.

This list should not be interpreted as meaning that every machine requires exactly the same documents.

The documentation must be appropriate to the specific machinery and sufficient to demonstrate its conformity.

14.3 General Description of the Machinery

The technical documentation should clearly identify which machinery has been assessed.

This may include:

• manufacturer,
• machinery designation,
• model,
• type,
• serial number,
• function,
• intended use,
• key technical characteristics,
• operating conditions,
• relevant interfaces.

The description should be sufficiently detailed for a technically competent person to understand the machinery and its intended application.

A simple product brochure will normally not be sufficient.

The technical documentation should establish a clear connection between the described machinery and the risks, technical solutions and tests documented later in the conformity assessment.

14.4 Design and Manufacturing Drawings

Drawings are an important part of the technical documentation.

Depending on the machinery, these may include:

• overall drawings,
• assembly drawings,
• detail drawings,
• electrical schematics,
• pneumatic diagrams,
• hydraulic diagrams,
• control-system drawings,
• safety circuits,
• relevant layouts.

The Machinery Directive specifically requires overall drawings of the machinery and drawings of the control circuits, together with descriptions and explanations necessary for understanding its operation.

This does not mean that every individual screw has to be documented.

The key question is:

Which information is necessary to assess the conformity of the machinery?

14.5 Calculations and Technical Evidence

Depending on the machinery, technical calculations may be required.

Examples include:

• strength calculations,
• stability calculations,
• load-bearing calculations,
• safety-distance calculations,
• stopping-time calculations,
• protective-measure calculations,
• electrical calculations,
• thermal calculations.

Measurement results and technical tests may also form part of the evidence.

The calculations should not be considered in isolation.

If, for example, a calculation is used to demonstrate that a protective device has sufficient mechanical strength, the documentation should make the following relationship clear:

Requirement → Calculation → Result → Technical implementation.

14.6 Risk Assessment and Protective Measures

The risk assessment is one of the most important elements of the technical documentation.

The Machinery Directive explicitly requires documentation of the risk assessment carried out.

This should demonstrate, among other things:

• which essential health and safety requirements are applicable,
• which hazards have been identified,
• which protective measures have been implemented,
• which residual risks remain.

The risk assessment should therefore not be treated as an isolated document that exists independently from the rest of the technical documentation.

It should be connected to the design.

For example:

Hazard

→ crushing point

Risk reduction

→ fixed guard

Technical implementation

→ specific design

Verification

→ safety-distance verification

Documentation

→ drawing + test record

This type of connection makes the technical documentation significantly more robust.

14.7 Applied Standards and Technical Specifications

The technical documentation should also identify the standards and other technical specifications used.

However, it should not simply contain a list of standard numbers.

A useful approach is to establish a relationship between:

• requirement,
• hazard,
• applied standard,
• technical solution,
• evidence.

For example:

Hazard	Protective Measure	Standard / Specification	Evidence
Unexpected start-up	Restart prevention	Relevant standard	Functional test
Crushing hazard	Protective guard	Relevant standard	Safety-distance verification
Electric shock	Protective conductor	EN 60204-1	Electrical test

This makes it considerably easier to understand why a particular standard was selected and what role it plays in the conformity assessment.

14.8 Test and Measurement Results

The technical documentation should contain relevant test and measurement results.

Depending on the machinery, these may include:

• electrical safety tests,
• functional tests,
• safety-function tests,
• stopping-time measurements,
• noise measurements,
• EMC tests,
• temperature measurements,
• stability tests,
• mechanical tests.

The Machinery Directive requires the necessary investigations and tests to be carried out to determine whether the machinery is capable, by its design and construction, of being assembled and put into service safely. The corresponding results and reports are part of the technical documentation.

Not every test necessarily has to be performed by an external laboratory.

Depending on the requirement, testing may be performed by the manufacturer itself or by a testing organisation selected by the manufacturer.

The important point is that the evidence must be technically appropriate and traceable.

14.9 Components and Safety Components

Machinery often contains a large number of purchased components.

These may include:

• motors,
• frequency converters,
• sensors,
• light curtains,
• safety switches,
• safety relays,
• controllers,
• valves,
• power supplies,
• radio modules,
• complete subassemblies.

For such components, technical datasheets, manufacturer declarations, test reports, certificates or declarations of conformity may be relevant.

However, the manufacturer should not simply assume:

“The component is CE marked, therefore its use in our machinery is automatically compliant.”

Integrating a component into machinery can create new risks or interactions.

A safety component, for example, can only perform its intended safety function if:

• it has been installed correctly,
• the appropriate architecture is used,
• the required parameters have been configured,
• the interfaces operate correctly.

The conformity assessment of the machinery must therefore consider the actual integration of the component.

14.10 Instructions

The instructions are also part of the technical documentation.

The Machinery Directive requires the manufacturer to provide the necessary information and instructions. Article 5 explicitly identifies the provision of the required information as one of the conditions that must be fulfilled before machinery is placed on the market or put into service.

The instructions should address, as applicable:

• intended use,
• relevant safety information,
• installation,
• operation,
• maintenance,
• residual risks.

Consistency is particularly important.

The machinery, risk assessment and instructions should describe the same technical reality.

A common problem is, for example:

• the risk assessment describes one operating mode,
• the software implements another,
• the instructions describe a third.

Such inconsistencies can become problematic during a conformity review.

14.11 EC Declaration of Conformity

A copy of the EC Declaration of Conformity is also part of the technical documentation.

Annex II, Part 1, Section A of the Machinery Directive specifies the information that the declaration must contain.

This includes, among other things:

• manufacturer information,
• identification of the machinery,
• the declaration of conformity with the applicable requirements,
• and, where applicable, information concerning an involved notified body.

The declaration should correspond to the machinery that was actually assessed.

In particular, product identification, model and other relevant information should be unambiguous.

14.12 Declaration of Incorporation for Partly Completed Machinery

Different documentation requirements apply to partly completed machinery.

For such products, the Machinery Directive provides for a Declaration of Incorporation and assembly instructions.

The relevant technical documentation is described in Annex VII, Part B.

It must demonstrate, among other things:

• which essential requirements have been applied and fulfilled,
• which protective measures have been implemented,
• which residual risks remain,
• which standards and technical specifications have been applied,
• which tests have been carried out.

The Declaration of Incorporation and assembly instructions accompany the partly completed machinery until it is incorporated into the final machinery and subsequently become part of the technical documentation of the completed machinery.

This is an important distinction between complete machinery and partly completed machinery.

14.13 Retention and Updating

The technical documentation must not only be created.

It must also be retained and made available for the required period.

Under Annex VII, Part A, the technical documentation must be available to the competent authorities for at least 10 years after the date of manufacture of the machinery or, for series production, after the date of manufacture of the last unit.

The documentation does not necessarily have to be stored physically within the EU or permanently maintained in paper form.

However, it must be possible to compile it and make it available to the competent authorities within a period appropriate to its complexity.

Updating

An equally important question is when the technical documentation should be updated.

Possible triggers include:

• design changes,
• changes to safety functions,
• software changes,
• replacement of components,
• changes to the intended use,
• newly identified risks,
• changes to applied standards.

Technical documentation should therefore be treated as a living compliance record, rather than as an archive created once at the end of a project.

14.14 What Must Be Available to an Authority?

Competent authorities may request the technical documentation.

The manufacturer must therefore be able to compile and provide the relevant information.

A particularly problematic situation is one in which numerous documents exist but nobody can explain:

• which version of the machinery was assessed,
• which risk assessment belongs to that version,
• which standards were applied,
• which tests were performed,
• why particular protective measures were selected.

A large volume of documentation therefore does not automatically mean good technical documentation.

The key is traceability.

14.15 What Technical Documentation Should Not Become

Good technical documentation should not simply be a folder containing every document that happens to exist.

Typical problems include:

“Document Dump”

Hundreds of documents are stored without explaining which ones are relevant to conformity.

Outdated Documents

The technical documentation contains drawings or test reports for an earlier version of the machinery.

Missing Traceability

It is not possible to determine which test report relates to which machine or version.

Conflicting Versions

The risk assessment describes a different design from the current drawing.

Missing Evidence

A protective measure is claimed but is not supported by appropriate technical evidence or testing.

Missing Production Control

For series production, there is no documentation explaining how conformity with the assessed design is maintained across production.

14.16 A Practical Structure for the Technical Documentation

A useful internal structure could be:

01 – Product Identification

• Product data
• Model
• Type
• Serial number
• Intended use

02 – Machine Description

• General description
• Technical data
• Functional description

03 – Drawings

• Overall drawings
• Assemblies
• Electrical schematics
• Control systems

04 – Risk Assessment

• Hazards
• Risk evaluation
• Protective measures
• Residual risks

05 – Standards

• Applied standards
• Harmonisation status
• Requirement mapping

06 – Calculations

• Mechanical calculations
• Electrical calculations
• Safety distances
• Other technical evidence

07 – Test Reports

• Tests
• Measurements
• Functional tests
• Safety tests

08 – Components

• Relevant components
• Safety components
• Manufacturer documentation

09 – Instructions

• Operating instructions
• Safety information
• Maintenance information

10 – Declarations

• EC Declaration of Conformity
• Declarations of Incorporation where applicable
• Relevant manufacturer declarations

11 – Production Control

• Measures for maintaining conformity in series production

This is not a legally prescribed folder structure. It is simply a practical way of organising the required information in a traceable manner.

14.17 Technical Documentation as a Compliance Matrix

Technical documentation becomes particularly effective when it does not merely contain documents but makes the relationships between them visible.

For example:

Essential Health and Safety Requirement

→ relevant hazard

→ risk-reduction measure

→ applied standard

→ technical implementation

→ verification

→ test report

→ drawing / schematic

→ instructions

This creates a traceability chain.

Such a chain becomes particularly valuable when the machinery is modified later.

The manufacturer can then more easily determine which documents and evidence are affected by the modification.

14.18 Technical Documentation for Series Production

Series production creates an additional challenge.

It is not sufficient to build one compliant machine.

The manufacturer must also establish measures to ensure that the machines produced subsequently remain consistent with the assessed design and applicable requirements.

Annex VII therefore requires, for series production, documentation of the internal measures used to ensure continuing conformity.

These measures may include:

• defined production processes,
• bills of materials,
• approved components,
• inspection plans,
• end-of-line testing,
• software version control,
• change management,
• quality controls.

The technical documentation therefore does not only describe the design.

For series-produced machinery, it must also support the link between the assessed design and compliant production.

14.19 Common Mistakes in Technical Documentation

Mistake 1 – Creating the documentation only at the end

The documentation is assembled retrospectively after the machinery has already been completed.

Problem: Important information and evidence may be missing.

Mistake 2 – Risk assessment and design are not kept synchronized

The risk assessment is based on an older version of the machinery.

Problem: The documented risk reduction may no longer correspond to the actual machine.

Mistake 3 – Test reports without traceability

A test report exists, but it is not clear which machine or version it relates to.

Problem: The evidence chain becomes weak.

Mistake 4 – Collecting CE certificates from components

Numerous supplier certificates are collected without evaluating their significance for the complete machinery.

Problem: Conformity of individual components does not automatically demonstrate conformity of the complete machine.

Mistake 5 – Safety-related software changes are not documented

Safety-related software is modified without updating the technical documentation.

Problem: The assessed machine and the machine actually produced may no longer correspond.

Mistake 6 – Confusing the instructions with the technical documentation

The operating instructions are treated as the complete evidence of machinery conformity.

Problem: The instructions are only one part of the required documentation.

14.20 The Most Important Principle

The technical documentation should tell a technically and legally traceable story:

This is our machinery.

↓

These are its intended functions.

↓

These are the identified hazards.

↓

These are the applicable requirements.

↓

These are our protective measures.

↓

These are the applied standards and technical solutions.

↓

These are our calculations and tests.

↓

This is the resulting conformity assessment.

↓

This is the machinery that is actually produced and placed on the market.

When this chain is complete and traceable, the technical documentation fulfills its actual purpose.

14.21 Summary

Technical documentation is not simply an archive and not a collection of certificates.

It is the technical evidence behind the CE conformity of the machinery.

It should, in particular:

• clearly identify the machinery,
• document its design and control systems,
• contain the risk assessment,
• make protective measures traceable,
• document applied standards and technical specifications,
• provide calculations and test evidence,
• address relevant components and safety components,
• contain the instructions and Declaration of Conformity,
• address the additional documentation requirements applicable to partly completed machinery,
• document measures for maintaining conformity in series production,
• and remain available for at least ten years.

The most important practical principle is:

Good technical documentation does not merely state that machinery is compliant. It makes it possible to understand why the manufacturer reached that conclusion and on which technical evidence the conclusion is based.

Official sources: The key requirements covered in this chapter are primarily derived from Article 5 and Annex VII of Directive 2006/42/EC. For partly completed machinery, Article 13 and Annex VII, Part B are particularly relevant.

Chapter 15: Essential Health and Safety Requirements

The Machinery Directive does not simply require a manufacturer to make a machine “safe.”

It establishes a set of legally binding Essential Health and Safety Requirements (EHSRs) that apply to machinery within its scope.

These requirements are contained primarily in Annex I of Directive 2006/42/EC.

Understanding Annex I is therefore fundamental to understanding machinery compliance.

The requirements are deliberately written at a relatively high level. They establish the safety objectives that machinery must achieve without prescribing one single technical design solution for every machine.

This gives manufacturers flexibility to use appropriate technologies and engineering solutions while still having to achieve the required level of safety. (EUR-Lex)

15.1 What Are Essential Health and Safety Requirements?

The Essential Health and Safety Requirements are the mandatory requirements that machinery must satisfy with regard to its design and construction.

Annex I begins with a crucial principle:

The manufacturer must carry out a risk assessment to determine which health and safety requirements apply to the machinery.

The machinery must then be designed and constructed taking the results of that risk assessment into account. (EUR-Lex)

This means that Annex I is not simply a checklist that can be completed without considering the actual machine.

The requirements that become relevant depend on:

• the type of machinery,
• its intended use,
• its reasonably foreseeable misuse,
• its operating conditions,
• the hazards it creates,
• and the results of the risk assessment.

15.2 Are All Requirements in Annex I Applicable?

No.

This is one of the most important points to understand.

Annex I contains:

• requirements of general application,
• requirements addressing specific hazards,
• requirements for particular types of machinery,
• and additional requirements applicable only under specific circumstances.

The Directive explicitly states that the general part applies to all kinds of machinery, while the other sections address more specific hazards or types of machinery. The manufacturer must nevertheless examine the whole of Annex I to determine all relevant requirements. (EUR-Lex)

For example, a machine that performs lifting operations may have to address requirements in the lifting-specific section of Annex I.

A machine that does not perform lifting operations would not automatically have to comply with every lifting-specific requirement.

The correct approach is therefore:

Read Annex I → identify the hazards → determine the applicable requirements.

Not:

Read Annex I → assume every paragraph applies.

15.3 The Starting Point: Risk Assessment

The Essential Health and Safety Requirements cannot be properly applied without a risk assessment.

Annex I establishes an iterative process consisting of:

1. determining the limits of the machinery,
2. identifying hazards and hazardous situations,
3. estimating risks,
4. evaluating those risks,
5. eliminating hazards or reducing risks through protective measures. (EUR-Lex)

This is fundamental to the entire Machinery Directive.

The risk assessment therefore determines which parts of Annex I are relevant.

15.4 Determining the Limits of the Machinery

Before hazards can be systematically assessed, the manufacturer must determine the limits of the machinery.

These include the intended use and reasonably foreseeable misuse.

The Directive defines intended use as use in accordance with the information provided in the instructions.

Reasonably foreseeable misuse means a use that is not intended according to the instructions but may result from readily predictable human behaviour. (EUR-Lex)

This distinction is important.

A manufacturer cannot simply write an unrealistic restriction into the instructions and assume that all other foreseeable behaviour is irrelevant.

For example, if an operator is reasonably likely to:

• reach into a machine during adjustment,
• bypass a guard,
• attempt to clear a jam,
• enter a machine area for maintenance,
• use a control in an unexpected sequence,

these situations may need to be considered as part of the risk assessment.

15.5 Identifying Hazards

The next step is identifying hazards that can be generated by the machinery and the associated hazardous situations.

Depending on the machine, these may include:

Mechanical hazards

• crushing,
• shearing,
• cutting,
• entanglement,
• drawing-in,
• impact,
• ejection,
• falling objects,
• loss of stability.

Electrical hazards

• electric shock,
• electrical contact,
• short circuits,
• overheating,
• electrical energy remaining after shutdown.

Thermal hazards

• hot surfaces,
• cold surfaces,
• fire,
• explosion,
• hot materials.

Noise and vibration

• excessive noise,
• vibration transmitted to the operator,
• long-term exposure.

Radiation

Depending on the machine:

• optical radiation,
• laser radiation,
• electromagnetic radiation,
• ionising radiation.

Hazardous substances

Machinery may generate, use or release:

• dust,
• fumes,
• gases,
• vapours,
• liquids,
• other hazardous substances.

Ergonomic hazards

These may arise from:

• awkward working positions,
• excessive physical effort,
• repetitive movements,
• poor access,
• inadequate visibility,
• difficult maintenance operations.

Control-system hazards

Examples include:

• unexpected start-up,
• failure of a safety function,
• loss of control,
• incorrect commands,
• software-related failures affecting safety.

The actual hazards depend on the machine.

There is no universal hazard list that can simply be copied into every risk assessment.

15.6 Risk Is Not the Same as Hazard

A hazard and a risk are not the same thing.

A hazard is a potential source of injury or damage to health.

A risk results from the combination of the probability and severity of possible injury or harm arising from a hazardous situation. (EUR-Lex)

For example:

Rotating shaft

→ potential mechanical hazard.

But the actual risk depends on factors such as:

• whether a person can access the shaft,
• how fast it rotates,
• how long a person could be exposed,
• what injury could result,
• whether guards are installed,
• whether access is required during operation.

This distinction is important when evaluating machinery.

Simply identifying a hazard does not complete the risk assessment.

15.7 Risk Estimation and Risk Evaluation

Once hazards and hazardous situations have been identified, the manufacturer must estimate and evaluate the associated risks.

The Directive specifically refers to:

• the severity of possible injury or damage to health,
• and the probability of occurrence. (EUR-Lex)

Different companies may use different methodologies for documenting this process.

The important point is that the chosen approach should be:

• systematic,
• technically justified,
• appropriate for the machinery,
• consistently applied,
• and sufficiently documented.

A numerical risk score can be useful, but the mere existence of a numerical score does not itself demonstrate compliance.

The objective is to determine whether risk reduction is required and, if so, which measures are appropriate.

15.8 The Hierarchy of Risk Reduction

One of the most important principles in Annex I is the order in which risk-reduction measures must be considered.

The manufacturer must:

1. eliminate or reduce risks as far as possible through inherently safe design and construction;
2. take necessary protective measures for risks that cannot be eliminated;
3. inform users of residual risks and provide the necessary warnings and instructions. (EUR-Lex)

This hierarchy is fundamental.

It means that warnings and instructions should not be used as the primary solution when the risk could reasonably have been reduced through the machine’s design.

15.9 First Priority: Inherently Safe Design

The first priority is to eliminate or reduce risks through the design itself.

For example, instead of relying exclusively on a warning label around a dangerous moving mechanism, the manufacturer may be able to:

• reduce the movement speed,
• eliminate the dangerous movement,
• redesign the mechanism,
• increase the distance,
• change the geometry,
• reduce stored energy.

The preferred solution is therefore one where the hazard is reduced by design.

This principle is sometimes referred to as inherently safe design.

15.10 Second Priority: Protective Measures

If risks cannot be adequately eliminated through design, protective measures must be considered.

Examples include:

• fixed guards,
• movable guards,
• interlocking devices,
• light curtains,
• pressure-sensitive devices,
• emergency stop functions,
• protective barriers,
• safety control systems.

The protective measure must itself be appropriately designed and implemented.

Simply installing a device labelled “safety” does not automatically make the machine compliant.

The manufacturer must determine whether the protective measure provides the required level of risk reduction for the identified hazard.

15.11 Third Priority: Information and Warnings

Residual risks that cannot be sufficiently eliminated or protected against must be addressed through information for the user.

This may include:

• warnings,
• safety instructions,
• information about residual risks,
• required personal protective equipment,
• training requirements,
• specific operating procedures.

This is the third level of the hierarchy.

It should therefore not become the default solution.

A label stating:

“Danger – moving parts”

does not normally compensate for a missing guard where a guard could reasonably be provided.

15.12 Safety Integration Throughout the Machine’s Life

The Machinery Directive requires machinery to be designed and constructed so that it can be operated, adjusted and maintained without putting persons at risk under foreseeable conditions. (EUR-Lex)

This principle extends beyond normal production.

The manufacturer should consider safety during:

• transport,
• assembly,
• installation,
• commissioning,
• operation,
• adjustment,
• cleaning,
• maintenance,
• troubleshooting,
• repair,
• dismantling,
• disabling,
• scrapping.

The machine should therefore not be assessed only in its normal production mode.

15.13 Unexpected Start-Up

Unexpected start-up is a recurring safety issue in machinery.

A machine may be safe during normal operation but dangerous during:

• cleaning,
• maintenance,
• adjustment,
• fault recovery,
• jam removal.

The risk assessment must therefore consider whether energy can be restored or movement initiated unexpectedly.

Depending on the machine, solutions may include:

• isolation,
• locking devices,
• control-system functions,
• restart prevention,
• controlled reset procedures,
• safe maintenance modes.

The exact solution depends on the machine and its risk assessment.

15.14 Guards and Protective Devices

Annex I contains specific requirements concerning guards and protective devices.

A guard is a physical barrier used to provide protection.

A protective device is a device other than a guard that reduces risk, either alone or together with a guard. (EUR-Lex)

Examples include:

• fixed guards,
• movable guards,
• interlocking guards,
• light curtains,
• pressure-sensitive devices.

The selection should be based on the identified risk.

A protective device must also be designed so that it does not introduce additional unacceptable risks.

15.15 Controls and Control Systems

Controls are another major area of Annex I.

Control systems must be designed and constructed so that they are safe and reliable for the intended operating conditions.

Depending on the machine, the manufacturer may need to consider:

• normal start,
• stopping,
• emergency stop,
• restart,
• operating modes,
• manual controls,
• automatic operation,
• faults,
• loss and restoration of power,
• software,
• safety-related control functions.

This is particularly important for modern machinery in which safety increasingly depends on electronic and programmable control systems.

15.16 Emergency Stop

Where appropriate, machinery must be equipped with one or more emergency-stop devices.

The purpose is to prevent or minimise danger in emergency situations.

However, an emergency stop should not be treated as a substitute for normal safeguarding.

For example:

Normal protection

→ guard + interlock

Emergency measure

→ emergency stop

These functions serve different purposes.

The emergency stop is an additional protective measure for situations requiring rapid intervention.

15.17 Protection Against Electrical Hazards

Machinery may also present electrical hazards.

The applicable requirements depend on the machine and its electrical design.

The manufacturer may need to consider:

• protection against direct and indirect contact,
• electrical equipment,
• isolation,
• protection against overheating,
• fault conditions,
• residual electrical energy,
• grounding or protective conductors.

Relevant harmonised standards can provide detailed technical methods for demonstrating compliance with these requirements.

However, the starting point remains the applicable Essential Health and Safety Requirements.

15.18 Materials and Products

Annex I also contains requirements concerning materials and products used or generated during machine operation.

The materials used to construct the machinery, as well as products used or created during its operation, must not endanger people’s health and safety.

Where fluids are involved, the machine must be designed to prevent risks associated with:

• filling,
• use,
• recovery,
• draining. (EUR-Lex)

This is particularly relevant for machinery involving:

• hydraulic fluids,
• lubricants,
• coolants,
• chemicals,
• process gases,
• dust-producing processes.

15.19 Lighting

Lighting can also become a safety issue.

Annex I requires integrated lighting where the absence of suitable lighting could create a risk despite normal ambient lighting.

The design must also avoid:

• problematic shadows,
• irritating glare,
• dangerous stroboscopic effects on moving parts. (EUR-Lex)

This illustrates an important principle:

A requirement does not have to involve a dramatic mechanical hazard to be relevant to machinery safety.

Visibility and access can also affect risk.

15.20 Ergonomics

Machinery must take account of human factors.

The manufacturer should consider aspects such as:

• operator posture,
• physical effort,
• visibility,
• accessibility,
• repetitive actions,
• control placement,
• maintenance access,
• loading and unloading.

The European Commission provides specific guidance on applying the ergonomic health and safety requirements of Annex I and their relationship with harmonised standards. (IMIES)

Ergonomics is therefore not simply a matter of user comfort.

Poor ergonomic design can itself create health and safety risks.

15.21 Lifting Operations

Machinery presenting hazards associated with lifting operations is subject to additional requirements in Annex I.

These requirements address aspects such as:

• lifting operations,
• loads,
• stability,
• lifting accessories,
• mechanical strength,
• control systems,
• information and marking.

The relevant requirements are additional to the general machinery requirements and are triggered by the hazards associated with the particular machine. (EUR-Lex)

Examples of machinery that may require consideration of these requirements include:

• lifting machinery,
• cranes,
• hoists,
• lifting platforms,
• machinery incorporating lifting functions.

15.22 Requirements for Specific Types of Machinery

Annex I contains additional sections addressing specific categories of hazards and machinery.

Depending on the machine, additional requirements may concern:

• underground machinery,
• machinery for lifting persons,
• machinery used for work with foodstuffs,
• machinery for pesticides,
• portable and hand-held machinery,
• machinery for processing food,
• machinery for lifting operations.

The manufacturer must determine which sections apply based on the actual characteristics and hazards of the machine.

15.23 Noise and Vibration

Noise and vibration should not be treated as secondary considerations.

Where applicable, machinery must be designed and constructed so that risks resulting from airborne noise and vibration are reduced to the lowest level taking account of technical progress and available means of reducing the noise or vibration, particularly at source. (EUR-Lex)

This can influence the design itself.

Possible approaches may include:

• changing mechanical components,
• reducing vibration at the source,
• modifying operating speeds,
• improving isolation,
• changing the layout,
• reducing noise-generating mechanisms.

Again, the hierarchy of risk reduction is relevant.

15.24 Radiation

Some machinery generates or uses radiation.

Depending on the technology, this can include:

• laser radiation,
• optical radiation,
• electromagnetic fields,
• other forms of radiation.

The applicable requirements depend on the nature of the radiation and the specific machinery.

This is another reason why Annex I must be assessed based on the actual hazards rather than treated as a generic checklist.

15.25 Hazardous Substances

Where machinery uses or produces hazardous substances, the design should seek to prevent exposure where reasonably possible.

Potential sources include:

• dust,
• fumes,
• gases,
• vapours,
• process chemicals.

Possible risk-reduction measures can include:

• containment,
• extraction,
• ventilation,
• closed processes,
• automatic handling,
• filtration.

The manufacturer’s instructions may then address residual risks and necessary protective measures.

15.26 Maintenance and Access

Maintenance is one of the areas where machinery can become significantly more dangerous than during normal operation.

A machine may have protective systems designed around normal production, while maintenance requires access to areas that are normally inaccessible.

The manufacturer should therefore consider:

• access points,
• maintenance positions,
• cleaning,
• lubrication,
• adjustment,
• fault finding,
• replacement of components,
• stored energy,
• safe isolation.

The Machinery Directive’s safety-integration principle expressly requires consideration of the foreseeable lifetime of machinery, including transport, assembly, dismantling, disabling and scrapping. (EUR-Lex)

15.27 Residual Risks

Not every risk can necessarily be eliminated.

After applying the required design and protective measures, residual risks may remain.

These must be communicated appropriately to the user.

Examples could include:

• a remaining noise exposure,
• hot surfaces,
• unavoidable access during maintenance,
• specific handling risks,
• necessary use of PPE.

The important point is that residual risk information should correspond to the actual machine.

Generic warnings copied from another machine are not an adequate substitute for a machine-specific assessment.

15.28 The State of the Art

Annex I contains an important qualification.

The Essential Health and Safety Requirements are mandatory. However, taking the state of the art into account, it may not always be possible to meet the objectives in an absolute sense.

In such cases, the machinery must be designed and constructed, as far as possible, to approach those objectives. (EUR-Lex)

This does not mean:

“The technology is difficult, therefore we do not have to comply.”

Instead, the manufacturer must consider what technically appropriate risk-reduction measures are available.

This is one reason why machinery safety cannot be assessed purely by comparing a machine against a static checklist.

Technology evolves.

The appropriate technical solution may change over time.

15.29 How Standards Help With the Essential Requirements

This is where the relationship with the previous chapter becomes important.

The Machinery Directive defines the mandatory safety objectives.

Harmonised standards can provide technical methods for addressing those objectives.

For example:

Essential requirement

→ prevent access to a dangerous moving part

Technical solution

→ protective guard

Relevant standard

→ detailed requirements for guard design and safety distances

Verification

→ inspection / measurement / functional test

The standard therefore helps translate a legal requirement into a technically verifiable solution.

But the manufacturer remains responsible for determining whether the solution is appropriate for the machine.

15.30 A Practical EHSR Compliance Matrix

One of the most effective ways to manage Annex I is to create an EHSR compliance matrix.

For example:

Annex I Requirement	Applicable?	Hazard / Reason	Protective Measure	Standard	Verification	Evidence
1.1.2 Safety integration	Yes	Moving mechanisms	Guards + control measures	Relevant standards	Inspection / test	Risk assessment
1.2.1 Safety and reliability of control systems	Yes	Unexpected movement	Safety-related control system	Relevant standard	Functional test	Test report
1.2.3 Starting	Yes	Unexpected start	Controlled start	Relevant standard	Functional test	Test record
1.2.4 Stopping	Yes	Residual movement	Controlled stopping	Relevant standard	Measurement	Test report
1.3.7 Risks related to moving parts	Yes	Crushing / entanglement	Guards	Relevant standards	Inspection	Drawings + test
1.5.1 Electricity	Yes	Electric shock	Electrical protection	Relevant standard	Electrical test	Test report
1.7.4 Instructions	Yes	Residual risks	Instructions / warnings	Relevant standard	Document review	Manual

The exact requirements in such a matrix depend on the machine.

The objective is to demonstrate that the manufacturer has systematically considered the applicable requirements rather than simply claiming that “Annex I has been fulfilled.”

15.31 Common Mistakes

Mistake 1 – Treating Annex I as a simple checklist

Every requirement is marked “Yes” without explaining why.

Problem: The actual connection to the machine and its hazards is missing.

Mistake 2 – Assuming every requirement applies

The manufacturer treats every paragraph as mandatory for every machine.

Problem: Many requirements are conditional and depend on the actual hazards and characteristics of the machinery.

Mistake 3 – Using warnings instead of engineering controls

A warning label is used where a design or protective measure could reasonably reduce the risk.

Problem: This conflicts with the hierarchy of risk reduction.

Mistake 4 – Ignoring reasonably foreseeable misuse

Only the ideal operating procedure is assessed.

Problem: Predictable human behaviour may create additional hazardous situations.

Mistake 5 – Assessing only normal operation

Maintenance, cleaning, adjustment and fault recovery are ignored.

Problem: Dangerous situations frequently occur outside normal production.

Mistake 6 – Treating standards as a substitute for risk assessment

The manufacturer selects several standards and assumes the machine is therefore compliant.

Problem: Standards support compliance but do not replace the manufacturer’s risk assessment.

Mistake 7 – Failing to document why requirements are considered not applicable

Requirements are marked “N/A” without explanation.

Problem: There is no evidence that the requirement was actually evaluated.

A short technical justification is usually much more useful.

15.32 A Better Way to Work With Annex I

A robust workflow is:

1. Identify the machinery

↓

2. Define intended use

↓

3. Consider reasonably foreseeable misuse

↓

4. Determine the machinery limits

↓

5. Identify hazards

↓

6. Identify applicable Annex I requirements

↓

7. Estimate and evaluate risks

↓

8. Apply risk reduction according to the hierarchy

↓

9. Select appropriate standards

↓

10. Implement the technical measures

↓

11. Verify the measures

↓

12. Document residual risks

↓

13. Complete the EHSR compliance matrix

↓

14. Integrate the results into the technical documentation

This creates a direct connection between the legal requirements and the actual machine.

15.33 The Most Important Principle

The Essential Health and Safety Requirements should not be treated as paperwork that is completed after the machine has been designed.

They are intended to influence the design and construction of the machinery itself.

The Directive explicitly requires the machinery to be designed and constructed taking the results of the risk assessment into account. (EUR-Lex)

Therefore:

Compliance should begin with the design, not with the CE marking.

The earlier safety requirements are incorporated into the engineering process, the easier it is to eliminate hazards at their source.

15.34 The Machinery Directive Is Performance-Based

One of the strengths of the Machinery Directive is that it does not prescribe one design for every machine.

The Essential Health and Safety Requirements define safety objectives.

Manufacturers can then select technically appropriate solutions.

This is particularly important because machinery technology changes continuously.

A machine manufactured today may use technologies that were not common when the Machinery Directive was adopted.

The legal requirements therefore need to be interpreted together with:

• the actual hazards,
• the state of the art,
• relevant harmonised standards,
• engineering principles,
• and the intended application.

15.35 Important Transition to the New Machinery Regulation

Manufacturers should also be aware that the European machinery legislation is changing.

Regulation (EU) 2023/1230 on machinery products will replace the Machinery Directive framework for products falling under the new Regulation.

The Regulation will generally apply from 20 January 2027. (EUR-Lex)

This does not mean that the Machinery Directive can simply be ignored today.

For machinery currently being placed on the market under the Directive, the applicable legal framework and transition provisions must be determined according to the relevant dates and circumstances.

However, manufacturers developing machinery with a long product lifecycle should already consider the upcoming Regulation during their compliance planning.

This is particularly important for projects that will continue beyond January 2027.

15.36 Summary

The Essential Health and Safety Requirements in Annex I form the technical core of the Machinery Directive.

They establish mandatory safety objectives covering areas such as:

• safety integration,
• mechanical hazards,
• control systems,
• stopping and starting,
• guards,
• protective devices,
• electrical hazards,
• ergonomics,
• noise and vibration,
• radiation,
• hazardous substances,
• maintenance,
• lifting,
• residual risks,
• instructions and information.

Not every requirement applies to every machine.

The manufacturer must determine the applicable requirements based on the machine’s characteristics and the results of the risk assessment. (EUR-Lex)

The most important principles are:

Identify the hazards.

Determine the applicable Essential Health and Safety Requirements.

Reduce risks through design first.

Use protective measures for remaining risks.

Inform users about residual risks.

Verify and document the results.

This creates the fundamental chain:

Hazard → Risk → Requirement → Risk Reduction → Verification → Evidence

That chain should ultimately connect the machinery’s physical design, its control system, its instructions and its technical documentation.

Official sources: The primary source for this chapter is Annex I of Directive 2006/42/EC. The European Commission’s official Machinery Directive application guide provides additional explanations and examples for applying these requirements in practice. (EUR-Lex)

Chapter 16: Conformity Assessment and Notified Bodies

Conformity assessment is the process through which the manufacturer demonstrates that a machine complies with the applicable requirements of the Machinery Directive.

An important distinction must be made from the outset:

Conformity assessment does not automatically mean assessment by an external organization.

For many machines, the manufacturer can carry out the conformity assessment procedure itself. A notified body is required only where the Machinery Directive provides for its involvement for the particular machine and the applicable conformity assessment procedure.

The applicable procedure depends in particular on whether the machine falls within Annex IV of the Machinery Directive and, where relevant, whether the applicable harmonised standards have been fully applied.

The relevant provisions are primarily found in Articles 12 and 14 and Annexes VIII, IX and X of Directive 2006/42/EC.

16.1 What Does Conformity Assessment Mean?

Conformity assessment means that the manufacturer systematically determines and documents whether the machine complies with the requirements applicable to it.

It is not a single certificate.

Instead, conformity assessment encompasses the activities necessary to establish conformity, including:

• identifying the applicable legal requirements;
• carrying out the risk assessment;
• selecting appropriate technical solutions;
• applying relevant standards;
• performing necessary inspections and tests;
• compiling the technical documentation;
• preparing the EC Declaration of Conformity; and
• affixing the CE marking.

The manufacturer remains responsible for the conformity of the machine.

External assessment by a notified body is required only where the applicable conformity assessment procedure requires it.

16.2 The Basic Principle of the Machinery Directive

Article 12 of the Machinery Directive distinguishes between machinery that does not fall within Annex IV and machinery that does.

For machinery outside Annex IV, the applicable procedure is generally the internal checks on manufacture described in Annex VIII.

For machinery listed in Annex IV, additional rules apply.

The available procedure depends, among other things, on:

• whether relevant harmonised standards have been applied;
• whether those standards cover all relevant essential health and safety requirements; and
• whether the machinery has been manufactured in accordance with those standards.

Therefore, neither of the following general statements is correct:

“Every machine requires a notified body.”

or:

“The manufacturer can always assess the machine completely on its own.”

The correct procedure must be determined by applying Article 12 together with Annex IV.

16.3 Internal Checks on Manufacture

For machinery that does not fall within Annex IV, the internal checks on manufacture are the standard conformity assessment procedure.

The manufacturer performs the conformity assessment itself.

This means that the manufacturer must, among other things:

• compile the technical documentation;
• ensure that the manufacturing process produces machinery consistent with that documentation;
• ensure compliance with the Machinery Directive;
• perform the necessary inspections and tests;
• draw up the EC Declaration of Conformity; and
• affix the CE marking.

Annex VIII explicitly describes this procedure as one in which the manufacturer or authorised representative ensures and declares that the machinery concerned satisfies the relevant requirements of the Directive.

No notified body is involved in this procedure.

16.4 What Does “Internal Checks on Manufacture” Mean?

The term can sometimes be misunderstood.

“Internal” does not mean that the machine only needs a superficial inspection.

The manufacturer still has to carry out the necessary conformity assessment activities.

In particular, the manufacturer must ensure that the manufacturing process produces machines that conform to:

• the technical documentation;
• the assessed design;
• the defined protective measures; and
• the applicable requirements of the Machinery Directive.

This is particularly important for series production.

The conformity assessment is therefore not simply a one-time review of a prototype. The manufacturer must also have appropriate measures in place to ensure that production machines remain consistent with the assessed design.

16.5 Machinery Listed in Annex IV

Annex IV contains categories of machinery for which the Machinery Directive establishes special conformity assessment rules.

Examples include certain:

• machinery presenting particular safety risks;
• woodworking machinery;
• presses;
• injection moulding machinery;
• vehicle lifts;
• machinery for lifting persons;
• portable cartridge-operated fixing and other impact machinery; and
• certain safety components.

The exact classification must always be checked against the applicable wording of Annex IV.

A machine does not fall under Annex IV merely because it is generally considered “dangerous”.

It must correspond to one of the categories specifically listed there.

16.6 Why Is Annex IV So Important?

Classification under Annex IV can have a significant impact on the conformity assessment procedure.

For a machine outside Annex IV, the manufacturer can generally use the internal checks on manufacture under Annex VIII.

For an Annex IV machine, however, additional procedures may become available or necessary depending on the application and coverage of harmonised standards.

The question:

“Does this machine fall within Annex IV?”

should therefore be answered early in the project.

It is a regulatory classification question that can affect the entire compliance strategy and should not be left until the CE marking stage.

16.7 Annex IV Machinery and Full Application of Harmonised Standards

Where a machine falls within Annex IV and has been manufactured in accordance with the relevant harmonised standards, provided those standards cover all relevant essential health and safety requirements, Article 12(3) allows three possible routes:

1. internal checks on manufacture according to Annex VIII;
2. EC type-examination according to Annex IX combined with internal checks on manufacture; or
3. full quality assurance according to Annex X.

This means that, under these conditions, an Annex IV machine can still be subject to a procedure without mandatory involvement of a notified body.

This is an important point because the common statement:

“Annex IV automatically means a notified body.”

is not generally correct under the Machinery Directive.

16.8 When Harmonised Standards Are Not Fully Applied

A different situation arises where:

• no relevant harmonised standards exist;
• relevant harmonised standards have only been partially applied;
• the applied standards do not cover all relevant essential health and safety requirements; or
• the machine has not been manufactured in accordance with the relevant harmonised standards.

For an Annex IV machine, Article 12(4) provides essentially two routes:

• EC type-examination under Annex IX combined with internal checks on manufacture; or
• full quality assurance under Annex X.

This is where the involvement of a notified body becomes relevant.

16.9 The Three Conformity Assessment Routes

For Annex IV machinery, the relevant routes can therefore be summarised as follows:

Procedure	Legal basis	Notified body
Internal checks on manufacture	Annex VIII	No
EC type-examination + internal checks on manufacture	Annex IX + Annex VIII	Yes
Full quality assurance	Annex X	Yes

The appropriate route must be determined based on the actual machine and the conditions of Article 12.

16.10 EC Type-Examination

Under EC type-examination, a notified body examines a representative specimen of the machinery.

This specimen is referred to as the type.

The notified body examines, as applicable:

• the technical documentation;
• the design;
• the standards applied;
• solutions used where harmonised standards have not been applied;
• and the machine itself through appropriate examinations, measurements and tests.

The purpose is to determine whether the type complies with the applicable requirements of the Machinery Directive.

If the assessment is successful, the notified body issues an EC type-examination certificate.

16.11 What Is a Representative Type?

An EC type-examination does not mean that every individual machine in a production series is separately examined by the notified body.

Instead, a representative type is assessed.

The manufacturer must then ensure that the machines placed on the market correspond to the assessed type.

The basic principle is therefore:

Type examined

↓

Type demonstrated to comply

↓

Production must conform to the examined type

↓

Manufacturer performs internal production controls

This is why EC type-examination is combined with internal checks on manufacture.

16.12 What Does the Notified Body Examine?

Under Annex IX, the notified body examines the technical documentation and identifies which parts of the machinery were designed in accordance with the relevant harmonised standards and which solutions do not rely on such standards.

Where necessary, it performs or arranges appropriate:

• inspections;
• measurements; and
• tests.

The objective is to establish whether the machine complies with the applicable essential health and safety requirements.

The notified body therefore performs a defined conformity assessment function.

It does not simply take over the manufacturer’s overall responsibility for the machine.

16.13 Changes to a Machine Subject to Type-Examination

A particularly important issue is what happens when a machine is modified after type-examination.

Changes may include:

• replacing a safety-related component;
• changing the machine design;
• modifying the control system;
• changing a safety function;
• replacing the drive system; or
• making significant software changes.

The manufacturer must determine whether the change affects the conformity of the machine or the validity of the type-examination.

An EC type-examination certificate is therefore not a general permission to make unlimited changes to the machine.

The Machinery Directive contains specific provisions concerning the continuing validity of EC type-examination certificates and their review in light of the state of the art.

16.14 Validity of an EC Type-Examination Certificate

Annex IX requires the validity of an EC type-examination certificate to be reviewed periodically.

The manufacturer is required to request a review of the certificate’s validity every five years.

Where the notified body confirms that the certificate remains valid in light of the state of the art, it may extend the certificate for another five years.

If the certificate is not renewed, the manufacturer must cease placing the relevant machinery on the market on the basis of that certificate.

This is an important distinction from a certificate that is simply issued once and then assumed to remain valid indefinitely.

16.15 Full Quality Assurance

The procedure under Annex X takes a different approach.

Instead of focusing primarily on a single machine type, the notified body assesses the manufacturer’s quality assurance system.

The system must cover the relevant activities concerning:

• design;
• manufacture;
• final inspection; and
• testing.

The notified body assesses and approves the quality system and supervises its application.

The emphasis is therefore on the manufacturer’s ability to consistently design and manufacture compliant machinery.

16.16 Type-Examination or Full Quality Assurance?

For manufacturers of Annex IV machinery, both approaches can be relevant.

EC type-examination

Focus:

The product / type

The notified body examines a representative machine type.

Full quality assurance

Focus:

The manufacturer’s quality system

The notified body assesses the system covering the design, manufacture and testing of the machinery.

The more appropriate approach depends on factors such as:

• product portfolio;
• manufacturing structure;
• change management;
• existing quality systems;
• number of machine models; and
• internal resources.

The decision is therefore not purely technical. It can also be an organisational and strategic decision.

16.17 When Is a Notified Body Required?

The key question is:

Does the conformity assessment procedure applicable to this specific machine require the involvement of a notified body?

For machinery outside Annex IV, this is generally not the case.

For Annex IV machinery, the answer depends on the conditions established by Article 12, particularly the availability and application of relevant harmonised standards.

A notified body becomes necessary, for example, where the conditions for the internal procedure are not met and the manufacturer therefore uses EC type-examination or full quality assurance.

16.18 A Notified Body Is Not Simply a “CE Certification Body”

This distinction is important.

A notified body does not automatically “certify CE compliance” for every machine.

It performs the specific conformity assessment procedure for which it has been notified.

A notified body may be notified for:

• particular machinery categories; and
• particular conformity assessment procedures.

It may therefore be suitable for one machine and unsuitable for another.

The manufacturer’s task is to verify the actual scope of notification.

16.19 Selecting a Notified Body

The selection should not be based solely on price.

Important criteria include:

1. Correct machinery category

Is the body notified for the relevant category?

2. Correct conformity assessment procedure

Can it perform, for example:

• EC type-examination?
• full quality assurance?

3. Technical competence

Does it have expertise in the relevant technology?

4. Experience with similar machinery

Has it assessed comparable machines before?

5. Project process

How does it handle:

• document review;
• testing;
• technical questions;
• corrective actions;
• design changes?

6. Time and cost

What examinations are required and what are the associated costs?

A lower initial quotation may not necessarily result in a lower overall project cost if the process is inefficient or the body lacks experience with the particular technology.

16.20 NANDO – The Official Database

The European Commission provides information on notified bodies through NANDO, the New Approach Notified and Designated Organisations Information System.

The database can be used to verify:

• the notified body;
• its identification number;
• the legislation under which it is notified;
• the conformity assessment procedures for which it is notified; and
• the relevant product or machinery categories.

The European Commission directs users to NANDO when looking for notified bodies under EU product legislation.

16.21 Why the NANDO Entry Matters

A manufacturer should not rely solely on a conformity assessment organisation’s own website stating:

“We are approved for the Machinery Directive.”

The relevant notification should be verified through the official EU information.

The assessment should establish:

Organisation

↓

Notified body number

↓

Relevant legislation

↓

Conformity assessment procedure

↓

Relevant machinery category

Only the complete combination demonstrates that the body is appropriately notified for the intended assessment.

16.22 The Notified Body Number

A notified body receives a unique identification number.

This number becomes relevant where the applicable conformity assessment procedure requires the involvement of a notified body and the corresponding CE marking rules apply.

However, the number by itself does not demonstrate that the organisation can assess every machine.

The scope of notification remains decisive.

16.23 Responsibilities of the Notified Body

The responsibilities depend on the selected procedure.

For EC type-examination, the notified body may:

• review the application;
• assess the technical documentation;
• examine the type;
• perform or arrange tests;
• determine whether the applicable requirements are satisfied; and
• issue an EC type-examination certificate.

Under full quality assurance, the notified body instead assesses and supervises the manufacturer’s quality system for design, manufacture and testing.

16.24 What the Notified Body Does Not Take Over

Involving a notified body does not transfer the manufacturer’s legal responsibility for the machine.

The manufacturer remains responsible for:

• the machine;
• its design;
• compliance with applicable legislation;
• manufacturing;
• technical documentation;
• conformity of production machines;
• the Declaration of Conformity.

The notified body performs the tasks assigned to it under the specific conformity assessment procedure.

16.25 Independence and Competence

Annex XI establishes criteria for notified bodies.

Among other requirements, the body and its personnel must be independent and must not, for example, be involved as the designer, manufacturer, supplier or installer of the machinery they assess.

The body must have appropriate technical competence and suitably qualified personnel.

These requirements are intended to ensure that conformity assessment is performed objectively and without inappropriate commercial or other conflicts of interest.

16.26 What Happens if Non-Conformity Is Found?

A notified body may identify situations where:

• requirements have not been fulfilled;
• requirements are no longer fulfilled;
• a certificate should not have been issued; or
• an approved quality system no longer meets the applicable requirements.

Depending on the circumstances, the notified body may take measures such as:

• restricting a certificate;
• suspending a certificate; or
• withdrawing a certificate,

where appropriate corrective action is not taken.

The Machinery Directive provides specific provisions governing these situations.

A successful assessment therefore does not mean that non-compliance can be ignored later.

16.27 Typical Process for an EC Type-Examination

For a manufacturer, the process can typically be structured as follows:

1. Classify the machine

↓

2. Determine whether Annex IV applies

↓

3. Identify relevant harmonised standards

↓

4. Determine the applicable conformity assessment procedure

↓

5. Select an appropriate notified body, where required

↓

6. Prepare the technical documentation

↓

7. Submit the application for EC type-examination

↓

8. Provide the representative type and required documentation

↓

9. Assessment and testing by the notified body

↓

10. Correct identified non-conformities

↓

11. Obtain the EC type-examination certificate

↓

12. Ensure series production remains consistent with the examined type

↓

13. Carry out the required internal production controls

↓

14. Draw up the Declaration of Conformity

↓

15. Affix the CE marking

16.28 A Common Mistake: Involving the Notified Body Too Late

For complex machinery, it is often advisable to involve the selected notified body early enough in the project.

If the body identifies only at the final assessment that:

• a protective measure needs to be redesigned;
• a required test is missing;
• a standard has been incorrectly applied; or
• the machine requires a different technical solution,

significant delays can result.

Early planning can therefore reduce project risk.

However, an informal technical discussion should not be confused with the formal conformity assessment itself.

16.29 Another Common Mistake: Selecting the Wrong Body

An organisation may be an experienced testing or certification company and still not be the correct notified body for a particular machine.

For example, it may:

• be notified for other machinery categories;
• be notified only for certain procedures; or
• be notified under other EU legislation but not for the relevant Machinery Directive procedure.

The official notification scope should therefore always be checked.

16.30 Conformity Assessment Is Not the Same as Certification

These terms should not be used interchangeably.

Conformity assessment

= the overall process used to determine and document conformity.

EC type-examination

= one specific conformity assessment procedure.

EC type-examination certificate

= the document issued following successful completion of an EC type-examination.

CE marking

= the manufacturer’s declaration, through the prescribed marking, that the applicable EU requirements have been fulfilled.

Understanding this distinction prevents one of the most common misconceptions surrounding CE compliance.

16.31 A Practical Decision Tree

The decision can be simplified as follows:

Question 1

Does the machine fall within Annex IV?

No

→ Internal checks on manufacture under Annex VIII.

Yes

↓

Question 2

Have the relevant harmonised standards been fully applied and do they cover all relevant essential health and safety requirements?

Yes

→ Annex VIII is available.

Alternatively:

→ Annex IX + Annex VIII

or

→ Annex X.

No

→ Annex IX + Annex VIII

or

→ Annex X.

This is a simplified decision model. The exact wording and conditions of Article 12 and Annex IV must always be checked for the particular machine.

16.32 Machinery Directive and Machinery Regulation

For new machinery projects, manufacturers must also consider that the Machinery Directive is being replaced by Regulation (EU) 2023/1230 on machinery products.

The new Regulation introduces a revised conformity assessment framework and distinguishes, among other things, between machinery categories listed in Parts A and B of its Annex I.

Depending on the category, procedures such as:

• internal production control;
• EU type-examination;
• conformity based on full quality assurance; or
• conformity based on unit verification

may apply.

The Regulation’s transitional provisions must therefore be considered when determining which legal framework applies to a particular product and date of placing on the market.

This is particularly important for projects extending into the period in which the new Regulation becomes applicable.

16.33 Common Conformity Assessment Mistakes

Mistake 1 – Treating CE marking as a certificate

The company treats CE marking as something that must be “obtained” from an external organisation.

Problem: CE marking is fundamentally the manufacturer’s declaration of conformity with the applicable EU legislation.

Mistake 2 – Checking Annex IV too late

The machine is designed first and its regulatory classification is considered only at the end.

Problem: The applicable conformity assessment route can affect the project from an early stage.

Mistake 3 – Automatically assuming that Annex IV requires a notified body

Every Annex IV machine is sent to an external body without checking the conditions of Article 12.

Problem: Under certain conditions, internal checks on manufacture remain an available route.

Mistake 4 – Assuming the notified body takes responsibility for the machine

The manufacturer treats the notified body as the party responsible for compliance.

Problem: The manufacturer remains responsible for the machine and its conformity.

Mistake 5 – Selecting a body without checking its notification scope

The company chooses a well-known organisation without verifying whether it is notified for the specific machinery category and procedure.

Problem: The organisation may not be authorised for the intended conformity assessment.

Mistake 6 – Ignoring changes after type-examination

The machine is significantly modified after the type-examination without assessing the impact on conformity.

Problem: The original assessment may no longer fully represent the machine being placed on the market.

16.34 What Should the Manufacturer Be Able to Explain?

At the end of the conformity assessment process, the manufacturer should be able to answer clearly:

Why was this conformity assessment procedure selected?

Why does the machine fall within or outside Annex IV?

Which harmonised standards were applied?

Do those standards cover the relevant essential health and safety requirements?

Was a notified body required?

If so, why?

Why was this particular notified body selected?

Which conformity assessment procedure was performed?

What certificate or other assessment result was issued?

How is conformity of series production maintained?

These questions provide a useful link between the initial regulatory classification and the final CE marking.

16.35 Summary

Conformity assessment under the Machinery Directive is a classification- and compliance-based process, not simply a search for a CE certificate.

For machinery outside Annex IV, the internal checks on manufacture under Annex VIII are generally applicable.

For machinery listed in Annex IV, the available route depends, among other things, on the application and coverage of relevant harmonised standards.

The relevant procedures include:

• internal checks on manufacture;
• EC type-examination combined with internal checks on manufacture; and
• full quality assurance.

A notified body is therefore not automatically required for every machine.

Where its involvement is required, the manufacturer must select a body whose official notification scope covers the relevant machinery category and conformity assessment procedure.

NANDO provides the official EU information needed to verify notified body status and scope.

The key principle is:

The first question is not “Do I need a certificate?” but “Which conformity assessment procedure does the applicable legislation require for this particular machine?”

That decision determines whether the manufacturer can perform the assessment internally or whether a notified body must be involved, and it establishes the regulatory path leading to the CE marking.

Chapter 17: Partly Completed Machinery

Not every machine covered by the Machinery Directive is placed on the market as a fully functional, stand-alone machine. In many industrial projects, modules or machine units are supplied first and are only intended to become part of a complete machine or production system.

For these situations, the Machinery Directive defines the concept of partly completed machinery.

The relevant provisions are primarily found in Article 2, Article 13 and Annex VI of Directive 2006/42/EC.

The distinction is important because partly completed machinery is subject to different conformity requirements from complete machinery.

17.1 Definition and Classification

Under Article 2, partly completed machinery is an assembly that is almost machinery but cannot in itself perform a specific application.

It is intended to be incorporated into, or assembled with, other machinery or partly completed machinery to form machinery to which the Machinery Directive applies.

Examples may include:

• drive units;
• automated machine modules;
• certain robotic or handling modules;
• production-line modules; and
• functional units that only perform their intended function after integration into a larger machine.

The product’s actual function and intended use are decisive. The name given to the product is not.

Classification should therefore be established during the product definition stage rather than only at the end of the project.

17.2 Difference Between Complete and Partly Completed Machinery

The fundamental distinction concerns the intended use.

A complete machine can perform its intended application.

Partly completed machinery is specifically intended to be incorporated into another machine.

This leads to different regulatory requirements:

	Complete machinery	Partly completed machinery
Can perform its intended application	Yes	Not yet completely
CE marking under the Machinery Directive	Yes	No
Declaration	EC Declaration of Conformity	Declaration of Incorporation
Instructions	Instructions	Assembly Instructions
Further integration required	Not necessarily	Yes

The specific requirements for partly completed machinery are established in Article 13 and Annex VI.

17.3 Risk Assessment for Partly Completed Machinery

Partly completed machinery must not be developed without addressing safety.

The manufacturer must identify the applicable essential health and safety requirements and assess the risks relevant to the partly completed machinery.

A key question is which risks:

• already exist within the module itself; and
• will only arise when it is integrated into the final machine.

Certain hazards may depend on:

• connection to another machine;
• shared access areas;
• a higher-level control system;
• common energy supplies; or
• interaction with operators.

The assessment therefore needs to consider the intended conditions and limits of integration.

The general principles of risk assessment are covered in detail in Chapter 8.

17.4 Technical Documentation

Technical documentation must also be prepared for partly completed machinery.

It must contain sufficient information to demonstrate compliance with the applicable requirements and to allow the subsequent integration to be performed safely.

Depending on the machinery, this can include information concerning:

• design and operating principles;
• applicable essential health and safety requirements;
• identified risks;
• protective measures;
• technical specifications;
• calculations and tests.

The documentation should also provide the information needed by the manufacturer responsible for completing the final machine.

The general requirements for technical documentation are discussed in Chapter 14.

17.5 Assembly Instructions

Instead of the instructions for use applicable to complete machinery, partly completed machinery is accompanied by assembly instructions.

These instructions must provide the information necessary for incorporation into the final machinery.

Depending on the product, this may include:

• installation requirements;
• mechanical interfaces;
• electrical connections;
• required protective measures;
• operating conditions;
• residual risks; and
• requirements for integrating safety functions.

The assembly instructions are therefore an important link between the manufacturer of the partly completed machinery and the manufacturer responsible for the final machine.

17.6 The Declaration of Incorporation

The manufacturer of partly completed machinery does not issue an EU Declaration of Conformity for the partly completed machinery.

Instead, a Declaration of Incorporation is prepared.

It identifies, among other things:

• which essential requirements have been applied and fulfilled;
• which technical documentation has been compiled;
• which harmonised standards or technical specifications have been applied, where applicable; and
• that the partly completed machinery must not be put into service until the final machinery into which it is incorporated has been declared compliant.

The Declaration of Incorporation is specified in Annex II, Part 1, Section B.

17.7 Responsibilities During Integration

The responsibilities of the parties must be clearly understood.

The manufacturer of the partly completed machinery must ensure that its product and the accompanying information adequately address the intended conditions of integration.

The manufacturer of the final machine must assess the complete machine.

This includes considering risks arising from the integration itself.

A common misconception is:

“The module is already CE compliant, so the complete machine is automatically compliant.”

That is not correct.

17.8 Integration into Complete Machinery

When partly completed machinery is incorporated into a complete machine, the resulting machine must be assessed as a whole.

Integration can create new or changed risks.

Examples include:

• a module now moving within an area accessible to operators;
• an internal movement becoming externally accessible;
• safety functions requiring integration with the higher-level control system;
• several machines sharing the same hazardous area; or
• a common emergency-stop function becoming necessary.

The interfaces therefore need to be considered from both a technical and safety perspective.

Where multiple machines are integrated into a complex assembly of machinery, additional considerations apply. These are addressed in Chapter 18 – Assemblies of Machinery.

17.9 Common Mistakes

Mistake 1 – Treating partly completed machinery as a finished machine

A manufacturer supplies a module intended for integration but treats it as a complete machine.

Problem: The regulatory classification may be incorrect.

Mistake 2 – No clearly defined integration boundary

It is unclear which safety functions are the responsibility of the module manufacturer and which belong to the integrator.

Problem: Responsibilities and residual risks become unclear.

Mistake 3 – Providing inadequate assembly instructions

The instructions cover only mechanical installation.

Problem: Safe integration may also require information about interfaces, protective measures and residual risks.

Mistake 4 – Missing Declaration of Incorporation

The required declaration is not provided with the partly completed machinery.

Problem: The documentation package is incomplete.

Mistake 5 – “CE of the individual modules = CE of the complete machine”

Several CE-marked components are assembled and the complete system is therefore assumed to be automatically compliant.

Problem: The conformity of the integration must be assessed separately.

17.10 Summary

Partly completed machinery is machinery that is not yet capable of performing its intended specific application independently and is intended to be incorporated into another machine.

The specific requirements include:

• no CE marking under the Machinery Directive as complete machinery;
• a Declaration of Incorporation;
• assembly instructions;
• technical documentation; and
• assessment of the relevant risks and applicable essential health and safety requirements.

The critical boundary is between the responsibility of the manufacturer of the partly completed machinery and the responsibility for the completed machine.

Once integration takes place, the resulting machine must be considered as a whole.

The specific challenges associated with integrating multiple machines and machine modules are addressed in the next chapter: Chapter 18 – Assemblies of Machinery.

Chapter 18: Assemblies of Machinery

Many industrial installations consist not of a single machine, but of several machines, partly completed machinery and other components that work together to perform a common production task.

The Machinery Directive explicitly addresses this situation. Several machines may constitute an assembly of machinery where they are arranged and controlled so that they function as an integrated whole for a common purpose.

This follows from the definition of “machinery” in Article 2(a) of Directive 2006/42/EC.

This is particularly relevant for:

• production lines;
• automated manufacturing systems;
• packaging lines;
• material-handling systems;
• interconnected processing machines;
• robotic cells; and
• automated assembly systems.

18.1 When Do Several Machines Become an Assembly?

Not every group of machines located next to each other constitutes an assembly of machinery.

Two aspects are particularly important:

Common objective

The machines or machine units must work together to achieve a common result.

Functional connection

They must be arranged and controlled so that they function as an integrated whole.

For example:

Machine A → Conveyor → Machine B → Inspection Station → Machine C

If these units form an integrated automated production process, the complete installation may constitute an assembly of machinery.

18.2 When Is It Not an Assembly?

Several machines positioned next to each other do not automatically become an assembly.

For example:

• Machine A produces a component.
• Machine B is located nearby.
• Both machines are operated independently.
• There is no common automated process or functional integration.

In such a situation, the machines may remain separate machines.

Physical proximity alone is therefore not sufficient.

18.3 The Importance of Control Systems

The control architecture is an important consideration.

Several machines may each operate independently. However, if they are connected through an overarching control system and operate together as an automated process, this can be relevant to their classification as an assembly.

Examples include:

• common PLC control;
• common safety control;
• mutual interlocks;
• automatic transfer of workpieces;
• interdependent machine enable signals; and
• common operating modes.

The question is therefore not only:

“Which machines are present?”

but also:

“How do these machines function together?”

18.4 The Assembly Must Be Considered as a Whole

Where an installation constitutes an assembly of machinery, it is not sufficient to assess only the individual machines.

The interfaces between the machines must also be considered.

New hazards can arise from:

• shared movement areas;
• automatic material transfer;
• interacting machine movements;
• common energy supplies;
• common operating modes;
• interconnected safety functions; and
• unexpected starting of one machine caused by another.

These hazards may not exist when the individual machines are considered separately.

18.5 Interfaces Are Particularly Critical

A typical problem occurs when every manufacturer considers only its own machine.

For example:

Machine A

→ Conveyor

→ Machine B

Both machines may be safe individually.

After integration, however, a situation may arise in which:

• a person can access the area between the machines;
• Machine B starts while Machine A is still operating in the same hazardous area;
• an emergency stop affects only one machine; or
• a guard door stops only part of the common hazardous area.

The safety of the complete assembly therefore cannot automatically be derived from the individual machine assessments.

18.6 Who Is Responsible for the Complete Assembly?

This responsibility should be established during project planning.

Someone must be clearly responsible for the integration and conformity of the complete assembly.

Depending on the project, this may be:

• the manufacturer of the complete installation;
• a system integrator;
• a machine builder combining several machines; or
• another company placing the integrated system on the market.

The relevant question is not simply who manufactured the individual machines, but who takes responsibility for the complete assembly as a product.

18.7 Individual CE Markings Are Not Sufficient

This is one of the most common mistakes with integrated production systems.

For example:

• Machine A → CE
• Robot → CE
• Conveyor → CE
• Machine B → CE

does not automatically mean:

Complete assembly → CE compliant

Integration can create hazards that did not exist in the individual machines.

The complete installation therefore needs to be assessed according to its actual configuration and intended operation.

18.8 Risk Assessment of the Complete Assembly

The risk assessment must go beyond the individual machines.

Particular attention should be given to:

Transfer points

Where workpieces or materials move from one machine to another.

Common hazardous areas

Areas where several machines can create hazards simultaneously.

Control systems

How do the individual machines influence each other?

Safety functions

Which machines must respond when a safety function is activated?

Operating modes

What happens during:

• automatic operation;
• setup;
• maintenance;
• fault conditions; and
• restart?

The general principles of risk assessment are covered in Chapter 8.

18.9 Emergency Stop Functions

Emergency stop functions are a particularly important issue in interconnected machinery.

With a single machine, it is usually relatively straightforward to determine which hazardous movements must be brought to a safe state.

With an integrated system, however, stopping one machine may affect several others.

For example, stopping one machine may result in:

• material continuing to move;
• another machine continuing to operate;
• a robot continuing its movement; or
• a workpiece remaining in a hazardous position.

The emergency stop function must therefore be considered in the context of the complete assembly.

18.10 Safety Control and Interfaces

The interfaces between the individual safety-related control systems require particular attention.

Depending on the system, this may involve:

• safety-related enabling signals;
• interlocks;
• safety-related signal exchange;
• common operating modes;
• defined responses to communication failures; and
• defined safe states following faults.

Responsibilities between the manufacturers and integrator should be clearly defined.

18.11 Technical Documentation

The documentation for the complete assembly must reflect the actual configuration.

In addition to the documentation of the individual machines, the integration aspects are particularly relevant, including:

• overall system layout;
• interfaces;
• control architecture;
• safety functions;
• common hazardous areas;
• risk assessment;
• protective measures; and
• relevant verification and testing.

The general requirements for technical documentation are discussed in Chapter 14.

18.12 A Common Project Failure: Responsibility Is Divided but Not Defined

A typical scenario looks like this:

Machine manufacturer A: “Our machine is CE compliant.”

Machine manufacturer B: “Our machine is also CE compliant.”

Integrator: “Then the complete system is CE compliant.”

But nobody has assessed:

What happens at the interfaces?

That is precisely where significant risks can arise.

Project responsibilities should therefore be defined explicitly, including:

• Who performs the integration risk assessment?
• Who defines common safety functions?
• Who verifies the complete control system?
• Who prepares the documentation for the complete assembly?
• Who is responsible for the conformity of the complete machine?

18.13 Practical Approach for an Integrated System

A structured assessment can follow this sequence:

1. Identify the individual machines

↓

2. Identify partly completed machinery

↓

3. Analyse the functional connections

↓

4. Determine the common objective

↓

5. Analyse control and safety interfaces

↓

6. Determine whether an assembly of machinery exists

↓

7. Assess integration-related risks

↓

8. Define common protective measures

↓

9. Document the complete assembly

↓

10. Assess conformity of the complete assembly

This prevents the assessment from stopping at the individual CE-marked machines.

18.14 Key Takeaway

For interconnected machinery, the key question is not:

“Are all individual machines CE marked?”

It is:

“Do these machines function together as an integrated assembly, and has that integration been assessed?”

The Machinery Directive expressly covers combinations of machinery and partly completed machinery that are arranged and controlled to function as an integrated whole for a common purpose.

In practice, this means:

The interfaces between machines can be just as important as the machines themselves.

The official European Commission guidance on the Machinery Directive provides additional explanations and practical examples concerning the application of these requirements.

Chapter 19: Placing Machinery on the Market and Putting It into Service

Conformity assessment is not the final legal step by itself. Before machinery can be placed on the EU market or put into service, the manufacturer must complete the obligations established by the Machinery Directive.

Article 5 sets out the principal obligations of the manufacturer or authorised representative. These include ensuring compliance with the applicable essential health and safety requirements, making the technical file available, providing the necessary information, completing the appropriate conformity assessment procedure, preparing the EC Declaration of Conformity and affixing the CE marking. (EUR-Lex)

19.1 “Placing on the Market” vs. “Putting into Service”

These two concepts should be distinguished.

Placing on the market

The Machinery Directive defines placing on the market as making machinery or partly completed machinery available for the first time in the EU, whether for payment or free of charge, with a view to distribution or use. (EUR-Lex)

This can therefore happen even if the machinery has not yet been used by its final operator.

Putting into service

Putting into service means the first use of the machinery for its intended purpose in the EU. (EUR-Lex)

For machinery manufactured for the manufacturer’s own use, putting into service can therefore be particularly important because there may be no conventional sale to a customer.

19.2 What Must Be Completed Beforehand?

Before placing machinery on the market or putting it into service, the manufacturer must ensure that the required compliance steps have been completed.

In practical terms, the final compliance gate should verify:

• applicable legislation has been identified;
• relevant essential health and safety requirements have been addressed;
• the risk assessment has been completed;
• the technical file is available;
• required instructions have been prepared;
• the applicable conformity assessment procedure has been completed;
• the EC Declaration of Conformity has been drawn up; and
• the CE marking has been correctly affixed.

These requirements follow directly from Article 5. (EUR-Lex)

The individual elements have already been discussed in detail in the preceding chapters.

19.3 The CE Marking Comes at the End

The CE marking should not be treated as the starting point of the compliance process.

It is the result of completing the applicable conformity assessment process.

The logical sequence is:

Requirements

↓

Risk assessment

↓

Design and protective measures

↓

Verification and testing

↓

Technical documentation

↓

Conformity assessment

↓

EC Declaration of Conformity

↓

CE marking

↓

Placing on the market / putting into service

The European Commission likewise describes CE marking as something that follows the necessary conformity assessment and documentation steps. (IMIES)

19.4 The Manufacturer’s Responsibility

The manufacturer has the primary responsibility for ensuring that the machinery complies with the applicable EU requirements.

This remains true even when:

• components are purchased from suppliers;
• testing is performed by an external laboratory;
• a consultant supports the project;
• a notified body is involved; or
• an integrator participates in the project.

External parties may perform specific tasks, but the manufacturer cannot simply transfer the overall responsibility for conformity to them.

The European Commission explicitly identifies the manufacturer as responsible for conformity assessment, technical documentation, the Declaration of Conformity and CE marking. (IMIES)

19.5 Machinery Manufactured for Own Use

The rules are not limited to machinery that is sold commercially.

A company that manufactures machinery for its own use can still fall within the manufacturer’s obligations.

This is particularly important for:

• custom production equipment;
• internally developed automation;
• special-purpose manufacturing machines;
• in-house robotic cells; and
• production lines constructed by the user itself.

The absence of a commercial sale does not automatically remove the Machinery Directive from consideration.

19.6 Modifications After Conformity Assessment

A machine may be modified after the original conformity assessment.

Examples include:

• changes to the control system;
• modifications to safety functions;
• changes to machine performance;
• new operating modes;
• changes to guarding;
• integration of additional equipment.

The important question is whether the modification can affect the machine’s conformity or fundamentally change its characteristics.

Such changes should therefore trigger a documented change assessment rather than simply being implemented as an engineering modification.

This is particularly important for machinery already assessed under a specific conformity assessment procedure.

19.7 Market Surveillance

Compliance does not end when the machine leaves the manufacturer’s premises.

Member States are responsible for market surveillance and may take measures where machinery does not comply with the applicable requirements.

The Machinery Directive establishes mechanisms allowing authorities to investigate machinery placed on the market or put into service and, where necessary, take appropriate action. (EUR-Lex)

This is one reason why the technical documentation and conformity assessment records must be maintained properly.

19.8 Practical Final Compliance Check

Before release, a manufacturer should be able to answer yes to the following:

Final check	Completed?
Applicable legislation identified	✓
Relevant safety requirements assessed	✓
Risk assessment completed	✓
Protective measures implemented	✓
Required testing completed	✓
Technical file available	✓
Instructions completed	✓
Conformity assessment completed	✓
EC Declaration of Conformity signed	✓
CE marking correctly applied	✓
Production configuration matches the assessed machine	✓

This checklist is not a substitute for the legal requirements, but it provides a useful final release gate.

19.9 Key Takeaway

Placing machinery on the market is not simply the act of selling it.

It is the point at which the manufacturer must have completed the applicable compliance process and be in a position to demonstrate conformity.

The central principle is:

Do not treat CE marking as the compliance process. Treat it as the final visible result of a completed compliance process.

Article 5 provides the legal framework for the manufacturer’s obligations before machinery is placed on the market or put into service. (EUR-Lex)

The next chapter will address another important practical issue: the information that must accompany machinery, including instructions, warnings, markings and other user information.

Chapter 20: Operating Instructions, Warnings and Marking

The Machinery Directive does not regulate only the technical design of machinery. Machinery must also be marked and documented in a way that allows it to be installed, operated, maintained and taken out of service safely.

The main requirements are contained in Annex I, Section 1.7 of Directive 2006/42/EC.

This includes requirements concerning:

• information and instructions;
• warnings;
• machinery marking;
• operating instructions;
• reasonably foreseeable misuse;
• residual risks;
• installation and commissioning;
• maintenance and repair.

The documentation is therefore not simply a final editorial task. It forms part of the machinery’s overall safety concept.

20.1 Information Must Support Safe Use

Annex I requires the information necessary for operating machinery to be provided in a form that is unambiguous and easily understood.

Displays and control devices must likewise be easy to understand and use.

The manufacturer must not consider only normal operation.

The instructions must also address reasonably foreseeable misuse.

This is an important principle:

The manufacturer must not only explain how the machinery is intended to be used, but also consider how it can realistically be misused.

20.2 Warnings About Residual Risks

Not every risk can be completely eliminated through design.

Where residual risks remain after:

1. inherently safe design measures;
2. safeguarding and protective measures; and
3. additional protective measures,

the user must be appropriately warned about them.

Examples may include:

• hot surfaces;
• stored energy;
• residual pressure;
• sharp edges;
• remaining crushing points; or
• necessary access to hazardous areas during maintenance.

Warnings should not, however, be used as a substitute for a technically feasible protective measure.

The overall hierarchy of risk reduction was already discussed in Chapter 8.

20.3 Marking of Machinery

Annex I, Section 1.7.3 requires machinery to bear visible, legible and durable markings.

The marking must generally include:

• the business name and full address of the manufacturer and, where applicable, the authorised representative;
• designation of the machinery;
• the CE marking;
• designation of series or type;
• serial number, if any; and
• year of construction.

Additional information may be required depending on the machinery.

For example, where a machine component must be moved with lifting equipment during use, its mass must be indicated clearly. Machinery intended for use in potentially explosive atmospheres is also subject to additional marking requirements.

20.4 The CE Marking

The CE marking forms part of the required machinery marking.

It should not, however, be considered in isolation.

As explained in Chapter 19, the CE marking comes at the end of the conformity process.

It does not mean that every individual component of the machinery has separately been assessed under the Machinery Directive. The relevant question is whether the product on which the marking is affixed complies with the applicable requirements.

The requirements concerning the form and affixing of the CE marking are set out in Annex III.

20.5 The Operating Instructions

Every machine must be accompanied by instructions in the official language or languages of the Member State in which it is placed on the market and/or put into service.

The Machinery Directive distinguishes between:

“Original instructions”

and

“Translation of the original instructions.”

Where a translation is provided, the original instructions must also accompany the machinery.

There is an exception for certain maintenance instructions intended exclusively for specialised personnel employed by the manufacturer.

20.6 What Must the Instructions Contain?

Annex I, Section 1.7.4.2 contains an extensive list of information that must be included in the instructions, insofar as it is relevant to the particular machinery.

This includes, among other things:

• manufacturer information;
• designation of the machinery;
• the EC Declaration of Conformity or its content;
• a general description of the machinery;
• necessary drawings and diagrams;
• descriptions of operator positions;
• intended use;
• warnings concerning known misuse;
• assembly, installation and connection instructions;
• information concerning noise and vibration reduction;
• information concerning commissioning and use;
• information concerning operator training, where applicable; and
• information concerning residual risks.

Additional information may be necessary depending on the type of machinery.

The operating instructions should therefore not be treated as a generic template that can simply be reused for every machine.

20.7 Maintenance, Repair and Troubleshooting

The instructions must also contain information necessary for maintenance and repair.

Depending on the machinery, this may include:

• maintenance intervals;
• required maintenance activities;
• access to maintenance points;
• safe conditions before maintenance;
• required tools;
• replacement of specific components;
• troubleshooting information; and
• restoration of safe operating conditions.

The exact content depends on the machinery and the risks identified during the risk assessment.

20.8 Installation and Assembly

Where relevant, the instructions must provide the necessary information for:

• assembly;
• installation;
• connection;
• securing; and
• positioning of the machinery.

This is particularly important where the safety of the machinery depends on its installation conditions.

Examples include:

• foundation requirements;
• electrical connections;
• pneumatic or hydraulic connections;
• required safety distances;
• installation of guards; and
• environmental requirements.

A machine can be safely designed and still become hazardous if it is incorrectly installed.

20.9 Operating Modes and Foreseeable Misuse

Good operating instructions do not simply say:

“Switch on the machine and start production.”

They should address the actual operating states foreseen for the machinery.

These may include:

• normal operation;
• setup;
• cleaning;
• maintenance;
• fault correction;
• shutdown; and
• restart.

Reasonably foreseeable misuse must also be considered.

20.10 Language Is a Compliance Requirement

Language requirements are frequently underestimated in machinery projects.

If machinery is placed on the German market, for example, the required operating instructions must be available in the applicable official language.

If the same machinery is subsequently placed on the market or first put into service in another EU Member State, additional language versions may be required.

Translation is therefore not merely a marketing or customer-service issue.

It is part of the regulatory requirements applicable to the machinery.

20.11 Common Mistakes in Operating Instructions

Mistake 1 – Generic operating instructions

A standard manual is used for several machine models even though their safety functions and risks differ.

Problem: The instructions may be incomplete or incorrect for the actual machine.

Mistake 2 – Only the intended use is described

Potentially foreseeable misuse is not addressed.

Problem: Annex I explicitly requires reasonably foreseeable misuse to be taken into account.

Mistake 3 – Residual risks are missing

The machine has been made safer through design measures, but remaining risks are not adequately communicated.

Problem: The information requirements of Sections 1.7.2 and 1.7.4 may not be fulfilled.

Mistake 4 – Instructions do not match the delivered machine

The software version, safety functions or hardware have changed, but the documentation has not been updated.

Problem: The documentation no longer describes the actual product.

Mistake 5 – Incorrect language version

Machinery is supplied in a Member State without the required language version of the instructions.

Problem: The requirements of Section 1.7.4 may not be fulfilled.

20.12 Marking and Documentation Must Be Consistent

A particularly important practical point is consistency.

The information appearing on:

• the nameplate;
• operating instructions;
• Declaration of Conformity;
• technical documentation; and
• test reports

should relate to the same machinery and product configuration.

For example, the designation and type information should not differ between the nameplate and the operating instructions.

Changes to machinery should therefore also trigger a review of the affected documentation.

20.13 Practical Documentation Check

Before placing machinery on the market, the manufacturer should verify at least the following:

Check	Status
Nameplate complete	✓
CE marking correct	✓
Manufacturer information correct	✓
Type/model designation consistent	✓
Serial number correct	✓
Year of construction correct	✓
Required warnings provided	✓
Operating instructions available	✓
Correct language version available	✓
Intended use described	✓
Foreseeable misuse addressed	✓
Residual risks described	✓
Assembly and installation described	✓
Operation and maintenance described	✓
Documentation matches the actual machine	✓

20.14 Summary

Operating instructions and marking are not simply documentation tasks performed at the end of a machinery project.

They are part of the machinery’s safety requirements.

The Machinery Directive requires, among other things:

• appropriate machinery marking;
• clear and understandable information;
• warnings concerning residual risks;
• operating instructions in the required official languages;
• information concerning intended use;
• consideration of reasonably foreseeable misuse; and
• information concerning installation, operation, maintenance and repair.

The key practical rule is:

The operating instructions must describe the machine that is actually supplied and the risks that actually remain — not an idealised or outdated version of the product.

The relevant requirements are primarily contained in Annex I, Sections 1.7.1 to 1.7.4 of the Machinery Directive.

Chapter 21: Existing Machinery, Used Machinery and Modifications

The Machinery Directive applies primarily to machinery that is newly placed on the EU market or put into service. A different situation arises when machinery already exists, is sold as used machinery, or is substantially modified.

This area is frequently misunderstood because not every modification automatically creates a new conformity assessment obligation under the Machinery Directive.

The starting point is therefore always to establish what happened to the machinery, where it is being supplied or used, and whether its characteristics have been changed in a way that affects its regulatory status.

21.1 New Machinery vs. Existing Machinery

The Machinery Directive applies to machinery when it is placed on the market or put into service within its scope.

For machinery that was already placed on the EU market before the Directive became applicable, the situation is different. The manufacturer did not retroactively have to apply the Machinery Directive to machinery that had already been lawfully placed on the market.

However, other requirements may apply to machinery already in use, particularly under workplace and occupational safety legislation.

This distinction is important:

Product compliance and workplace safety are related, but they are not the same legal question.

A machine may have been compliant when originally placed on the market while the employer nevertheless has obligations concerning its safe continued use.

21.2 Used Machinery

The Machinery Directive does not simply treat every second-hand machine as a new machine.

A used machine that has already been placed on the EU market generally does not become a “new machine” merely because it is subsequently sold to another user within the EU.

However, the situation can change when machinery is:

• imported from outside the EU for the first time;
• substantially modified;
• combined with other machinery;
• rebuilt or converted for a substantially different application.

The specific circumstances therefore need to be assessed before deciding which conformity obligations apply.

21.3 Importing Used Machinery from Outside the EU

A particularly important distinction concerns used machinery coming from a non-EU country.

If machinery has never previously been placed on the EU market and is imported into the EU, the importer may effectively be introducing machinery to the EU market for the first time.

The machinery must therefore comply with the applicable EU requirements.

Simply describing the machine as “used” does not remove the relevant product requirements.

This is an important practical point for companies purchasing machinery internationally.

21.4 Modifying Existing Machinery

Machinery is frequently modified during its lifetime.

Examples include:

• replacing a drive;
• changing the control system;
• increasing machine speed;
• adding a robot;
• modifying guarding;
• changing safety functions;
• adding automatic loading;
• integrating new software;
• changing the intended application.

Not every modification automatically means that the machine must undergo a completely new conformity assessment under the Machinery Directive.

The critical question is whether the modification changes the machine in a way that affects its compliance and whether the modified machine should be regarded as a new product being placed on the market or put into service.

21.5 Why a Modification Assessment Is Important

A company should not decide simply:

“It is only a modification, so CE is not relevant.”

Nor should it automatically assume:

“Every modification requires complete CE certification again.”

Both approaches can be incorrect.

A structured modification assessment should first establish:

1. What was changed?
2. Why was it changed?
3. Does the modification affect the machine’s hazards?
4. Does it affect existing protective measures?
5. Does it create new hazards?
6. Does it change the intended use?
7. Does it affect safety-related control functions?
8. Does it significantly increase performance or operating parameters?
9. Who is performing the modification?
10. Is the modified machine being placed on the market or put into service?

The result should be documented.

21.6 Changes to Safety Functions

Changes to safety-related functions deserve particular attention.

Examples include:

• replacing a safety PLC;
• changing the logic of an interlock;
• modifying emergency-stop functions;
• changing guard monitoring;
• changing safe speed functions;
• modifying access control.

A modification that appears technically small can have significant consequences for the machine’s safety concept.

The original risk assessment should therefore be reviewed where the modification affects the hazards or protective measures previously assessed.

The general risk assessment methodology is covered in Chapter 8.

21.7 Changes to the Intended Use

Changing what a machine is intended to do can be more significant than changing individual components.

For example:

A machine originally designed for:

automatic processing of product A

is modified for:

processing product B at a substantially higher speed.

The modification may change:

• mechanical hazards;
• material behaviour;
• operating parameters;
• operator interaction;
• guarding requirements;
• safety distances;
• control requirements.

The original conformity assessment may therefore no longer adequately represent the modified machine.

21.8 Adding New Machinery to an Existing Machine

Another common situation is the addition of equipment.

Examples include:

• adding a robot;
• adding a conveyor;
• adding an automatic loading system;
• adding a new processing unit;
• adding a vision system with automatic machine intervention.

The new equipment may have its own conformity status.

However, this does not automatically resolve the conformity of the resulting integrated system.

As discussed in Chapter 18, interfaces can create new hazards.

The integration therefore needs to be assessed according to the actual configuration.

21.9 Documentation After Modification

One of the most common practical failures is modifying machinery without updating its documentation.

Depending on the modification, relevant documents may include:

• risk assessment;
• drawings;
• electrical diagrams;
• software documentation;
• safety-function documentation;
• operating instructions;
• maintenance instructions;
• test records;
• technical documentation;
• Declaration of Conformity.

The objective is simple:

The documentation must continue to describe the machine that actually exists.

This principle was also discussed in Chapter 20 regarding operating instructions and marking.

21.10 Who Becomes Responsible?

Responsibility depends on the circumstances of the modification.

If a company substantially modifies machinery and subsequently places the modified machinery on the market or puts it into service as a new product, that company may assume manufacturer-type responsibilities for the resulting machinery.

This is why contracts with external machine builders and integrators should clearly define:

• scope of modification;
• responsibility for risk assessment;
• responsibility for conformity assessment;
• documentation responsibilities;
• testing and verification;
• CE marking responsibilities.

Simply describing a company as a “service provider” does not by itself determine the legal responsibilities.

21.11 A Practical Modification Assessment

Before modifying an existing machine, a structured review can be used:

Existing machine

↓

Define modification

↓

Identify affected functions

↓

Review hazards and protective measures

↓

Determine whether new hazards arise

↓

Review intended use and operating parameters

↓

Update risk assessment where necessary

↓

Determine applicable conformity obligations

↓

Update technical documentation

↓

Update instructions and markings where necessary

↓

Verify the modified machine

This approach prevents conformity questions from being discovered only after the modification has been completed.

21.12 A Common Mistake: “The Machine Already Has CE”

The fact that a machine carries a CE marking does not mean that every future modification is automatically covered by the original conformity assessment.

The CE marking relates to the machine as assessed and placed on the market.

If the machine is subsequently changed, the effects of those changes need to be evaluated.

A CE marking should therefore never be treated as a permanent exemption from further safety assessment.

21.13 Important Transitional Consideration: The Machinery Regulation

There is an additional issue that manufacturers need to consider today.

Directive 2006/42/EC is being replaced by Regulation (EU) 2023/1230 on machinery.

The new Machinery Regulation will generally apply from 20 January 2027, with the Machinery Directive ceasing to apply from that date, subject to the transitional provisions of the Regulation.

For manufacturers developing or substantially modifying machinery today, this transition should therefore be considered when planning:

• development timelines;
• conformity assessment;
• technical documentation;
• software and cybersecurity requirements;
• machinery placed on the market around the transition date.

The new Regulation introduces a number of changes that should be assessed separately rather than mixed into the requirements of Directive 2006/42/EC.

A detailed comparison between the Machinery Directive and Machinery Regulation should therefore be treated as a separate topic.

21.14 Practical Checklist

Before releasing a modified or used machine, ask:

Question	Check
Was the machine previously placed on the EU market?	✓
Is it being imported from outside the EU?	✓
What exactly has been modified?	✓
Does the modification affect hazards?	✓
Are safety functions affected?	✓
Has the intended use changed?	✓
Has the risk assessment been reviewed?	✓
Does the integration create new risks?	✓
Is additional testing required?	✓
Does the technical documentation still represent the machine?	✓
Do the operating instructions remain valid?	✓
Are markings still correct?	✓
Has the applicable conformity obligation been determined?	✓

21.15 Key Takeaway

Used machinery, existing machinery and modified machinery cannot be assessed simply by asking whether a CE marking is already present.

The correct starting point is to determine:

What is the status of the machine, what has changed, and is the resulting product being placed on the EU market or put into service as a new machine?

For modifications, a documented assessment should establish whether the changes affect the machine’s hazards, protective measures, intended use or conformity.

And because the EU regulatory framework is transitioning from Directive 2006/42/EC to Regulation (EU) 2023/1230, manufacturers planning machinery projects around the 2027 transition date should consider the new Regulation early.

22: Conformity Assessment Procedures and the Role of the Notified Body

Once the machine has been designed, the applicable requirements identified, the risk assessment completed and the necessary evidence prepared, the manufacturer must determine and carry out the appropriate conformity assessment procedure.

The Machinery Directive does not prescribe one single procedure for all machinery. The applicable procedure depends in particular on whether the machine is listed in Annex IV.

This distinction is important because it determines whether the manufacturer can generally perform the conformity assessment itself or whether, under certain circumstances, a Notified Body must be involved.

22.1 Conformity Assessment Is Mandatory

Article 12 of the Machinery Directive requires the manufacturer or its authorised representative to carry out an appropriate conformity assessment procedure before machinery is placed on the market or put into service.

The procedure depends primarily on the classification of the machinery under the Directive.

The first question is therefore:

Is the machine listed in Annex IV?

If not, the conformity assessment follows a different route from that applicable to Annex IV machinery.

22.2 Machinery Not Listed in Annex IV

For machinery not listed in Annex IV, Article 12(2) provides for the internal checks on the manufacture of machinery procedure set out in Annex VIII.

In practical terms, the manufacturer can generally carry out the conformity assessment under its own responsibility.

A Notified Body is not required for this procedure.

This does not mean that no assessment or testing is required.

The manufacturer must still:

• identify the applicable requirements;
• perform the necessary risk assessment;
• apply appropriate protective measures;
• perform the necessary inspections and tests;
• compile the technical documentation; and
• ensure that the machinery complies with the Machinery Directive.

The manufacturer therefore retains full responsibility for the conformity of the machine.

22.3 Machinery Listed in Annex IV

Annex IV contains specific categories of machinery considered to present particular risks.

The list includes, among others, certain:

• circular saws and other woodworking machinery;
• presses;
• lifting platforms;
• underground machinery;
• vehicle lifts;
• portable cartridge-operated fixing and other impact machinery;
• certain safety components.

The complete list is defined in Annex IV of the Machinery Directive.

For these machines, the conformity assessment procedure depends additionally on how the applicable harmonised standards have been used and whether they cover the relevant essential health and safety requirements.

22.4 Annex IV Does Not Automatically Mean a Notified Body

A common misconception is:

“Annex IV machinery always requires a Notified Body.”

That is not correct.

Under Article 12(3), where an Annex IV machine has been manufactured in accordance with relevant harmonised standards that cover all relevant essential health and safety requirements, the manufacturer may choose between several conformity assessment procedures:

1. internal checks on manufacture;
2. EC type-examination followed by internal checks on manufacture; or
3. full quality assurance.

Only the latter two involve a Notified Body.

This distinction can have a significant impact on project cost, timing and documentation.

22.5 When Is a Notified Body Required?

Where an Annex IV machine is:

• not manufactured according to the relevant harmonised standards;
• manufactured only partly according to those standards;
• manufactured according to standards that do not cover all relevant essential health and safety requirements; or
• not covered by relevant harmonised standards,

Article 12(4) applies.

The manufacturer must then use one of the following procedures:

• EC type-examination under Annex IX followed by internal checks on manufacture; or
• full quality assurance under Annex X.

A Notified Body is involved in both procedures.

22.6 The Main Procedures at a Glance

Situation	Conformity assessment procedure	Notified Body
Machinery not listed in Annex IV	Internal checks on manufacture	No
Annex IV machinery + relevant harmonised standards covering all relevant requirements	Internal checks, EC type-examination + internal checks, or full quality assurance	Depending on procedure
Annex IV machinery + standards not fully applicable / insufficient coverage / no relevant harmonised standard	EC type-examination + internal checks or full quality assurance	Yes

This structure follows Article 12 of Directive 2006/42/EC and its Annexes VIII to X.

22.7 What Does a Notified Body Do?

A Notified Body is a conformity assessment body that has been notified by a Member State to the European Commission for specific conformity assessment activities.

Its responsibilities depend on the procedure being applied.

For an EC type-examination, for example, the Notified Body assesses the relevant technical documentation and examines a representative model of the machinery.

The assessment may include:

• examination of the technical documentation;
• examination of the machinery;
• verification of relevant technical solutions;
• necessary tests and measurements;
• assessment against the applicable essential health and safety requirements.

If the requirements are fulfilled, the Notified Body issues an EC type-examination certificate.

22.8 Not Every Testing Laboratory Is a Notified Body

This distinction is important in practice.

A manufacturer may use:

• a testing laboratory;
• an engineering company;
• a safety consultant; or
• another technical service provider

to perform testing or provide technical support.

That does not automatically make the organisation a Notified Body.

A Notified Body must actually be notified for the relevant Machinery Directive conformity assessment activities.

The European Commission’s NANDO database can be used to verify the notification status and scope of a Notified Body.

22.9 Selecting the Correct Notified Body

Where a Notified Body is required, the manufacturer should not simply select any organisation offering machinery certification.

The manufacturer should verify:

• whether the organisation is notified under Directive 2006/42/EC;
• whether it is notified for the relevant machinery category;
• whether it is notified for the required conformity assessment procedure;
• whether the notification is currently valid; and
• whether its technical scope covers the particular machine.

The notification should therefore be checked against the official European Commission information rather than relying solely on the organisation’s marketing material.

22.10 EC Type-Examination

Under the EC type-examination procedure, the Notified Body examines a representative specimen of the machinery.

The manufacturer must provide the documentation and machinery required for the assessment.

The Notified Body determines whether the type complies with the applicable requirements of the Machinery Directive.

If it does, an EC type-examination certificate is issued.

The certificate does not, however, transfer responsibility for the machinery to the Notified Body.

The manufacturer remains responsible for ensuring that subsequently manufactured machines correspond to the approved type and comply with the applicable requirements.

22.11 Changes to an Approved Type

Changes to machinery that has already undergone EC type-examination require particular attention.

The manufacturer must inform the Notified Body of modifications to the approved type.

The Notified Body then determines whether the modification affects the validity of the existing certificate and whether a new assessment or certificate is necessary.

This can be particularly relevant where modifications affect:

• safety-related components;
• control systems;
• protective measures;
• operating parameters;
• intended use; or
• essential design characteristics.

The general treatment of modifications to existing machinery was already covered in Chapter 21. The point here is specifically the effect of such modifications on an existing type-examination.

22.12 Full Quality Assurance

The second procedure involving a Notified Body is full quality assurance under Annex X.

Unlike EC type-examination, this procedure is not limited to assessing one representative machine.

The Notified Body assesses the manufacturer’s quality assurance system covering areas such as:

• design;
• manufacture;
• final inspection; and
• testing of machinery.

The quality system must ensure that machinery is designed and manufactured in conformity with the applicable requirements of the Machinery Directive.

This approach can be particularly relevant for manufacturers producing machinery repeatedly under an established quality management system.

22.13 The Manufacturer Remains Responsible

The involvement of a Notified Body does not transfer the manufacturer’s overall legal responsibility for the machine.

The Notified Body performs the conformity assessment activities assigned to it under the selected procedure.

It does not become the manufacturer.

Therefore:

A Notified Body’s involvement does not mean that the manufacturer can transfer responsibility for the machine’s conformity to that body.

The manufacturer remains responsible for the product placed on the market.

22.14 Common Conformity Assessment Mistakes

Mistake 1 – Assuming every Annex IV machine requires a Notified Body

Annex IV classification must first be considered together with Article 12 and the applicable harmonised standards.

Mistake 2 – Involving the Notified Body too late

Where third-party assessment is required, it should be incorporated into the project plan from the beginning.

Late involvement can lead to:

• additional testing;
• design changes;
• missing documentation;
• additional samples;
• project delays.

Mistake 3 – Using an arbitrary testing organisation

A technically competent laboratory is not necessarily a Notified Body.

The organisation’s official notification and scope should be verified.

Mistake 4 – Treating type-examination as approval of every future machine

An EC type-examination concerns the assessed type.

The manufacturer must still ensure that production machinery corresponds to the approved type.

Mistake 5 – Deciding the conformity procedure at the end of the project

The conformity assessment procedure should be determined early.

It can influence:

• design decisions;
• test planning;
• documentation;
• project schedule;
• costs;
• component selection; and
• the selection and application of standards.

22.15 Practical Decision Process

The basic decision can be represented as follows:

Machine

↓

Is it listed in Annex IV?

No

→ Internal checks on manufacture

→ Manufacturer performs the conformity assessment

Yes

↓

Are relevant harmonised standards available and do they cover all relevant essential health and safety requirements?

Yes

The manufacturer can choose between:

• internal checks on manufacture;
• EC type-examination + internal checks on manufacture; or
• full quality assurance.

No

The manufacturer must use:

• EC type-examination + internal checks on manufacture;

or

• full quality assurance.

The legal basis is Article 12 in conjunction with Annexes VIII, IX and X of Directive 2006/42/EC.

22.16 Summary

The conformity assessment procedure is not simply a final administrative step before applying the CE marking.

It should be determined early in the machinery project, because it can affect the design, testing, documentation, schedule and cost of the project.

The central principle is:

Not every machine requires a Notified Body. The applicable procedure depends in particular on whether the machine falls within Annex IV and on the conditions established by Article 12.

For machinery outside Annex IV, internal checks on manufacture are generally applicable.

For Annex IV machinery, several procedures may be available where the relevant harmonised standards cover all applicable essential health and safety requirements. Where those conditions are not met, involvement of a Notified Body becomes necessary.

The official European Commission information and the NANDO database should be used to verify the current status and scope of a Notified Body before it is selected.

Chapter 23: Market Surveillance and Post-Market Responsibilities

CE marking is not the end of the manufacturer’s responsibility. Once machinery has been placed on the market or put into service, its conformity can still be examined by the competent authorities.

The Machinery Directive requires Member States to carry out market surveillance to ensure that machinery placed on the market complies with the applicable requirements and does not present a risk to health and safety.

23.1 What Is Market Surveillance?

Market surveillance refers to controls carried out by public authorities on products that are already available on the market.

For machinery, authorities may examine, for example:

• whether the machinery meets the applicable essential health and safety requirements;
• whether the required technical documentation is available;
• whether the EC Declaration of Conformity has been correctly established;
• whether the CE marking has been correctly affixed;
• whether the machinery presents a safety risk.

Market surveillance is carried out by the competent authorities of the Member States.

23.2 What Can an Authority Request?

If an authority has concerns about the conformity of machinery, it can request appropriate information and evidence.

For the manufacturer, this makes one point particularly important:

The technical documentation must actually be available, complete and traceable.

The Machinery Directive requires manufacturers to prepare and keep the technical documentation available and to carry out the applicable conformity assessment procedure before placing machinery on the market or putting it into service.

A CE marking by itself is therefore not sufficient evidence of conformity.

23.3 What Happens If Non-Conformity Is Found?

If a market surveillance authority determines that machinery does not comply with the applicable requirements or presents a safety risk, corrective measures may be required.

Depending on the circumstances, these can include measures to:

• correct the non-conformity;
• restrict the availability of the machinery;
• withdraw machinery from the market; or
• recall machinery.

The specific measure depends on the nature and severity of the non-conformity and the applicable market surveillance legislation. European market surveillance is intended to ensure that products available on the EU market comply with applicable requirements and do not create unacceptable risks.

23.4 Problems Discovered After Placing Machinery on the Market

Manufacturers should therefore continue to pay attention to safety issues after market launch.

New information can come from:

• customer feedback;
• service activities;
• accidents;
• complaints;
• internal investigations; or
• field experience.

When relevant information emerges, the manufacturer should determine whether it affects the conformity or safety of machinery already supplied.

Depending on the circumstances, this may require assessing whether:

• a technical modification is necessary;
• additional protective measures are required;
• the technical documentation needs to be updated;
• other machines are affected; or
• further action is required.

23.5 Importers and Distributors

Where machinery is manufactured by one company and supplied by another, importers and distributors may also have obligations.

This is particularly relevant when machinery is imported from outside the EU.

An importer should not assume that the presence of a CE marking automatically proves that all applicable requirements have been fulfilled.

The respective responsibilities of manufacturers, importers and distributors must be considered under the applicable EU product and market surveillance legislation.

23.6 Voluntary Certificates Do Not Replace Legal Compliance

Another common misconception is that an additional certificate can compensate for missing legal conformity.

The European Commission makes clear that voluntary certificates are generally not a recognised means of demonstrating compliance with mandatory EU harmonisation legislation. They should not be confused with a conformity assessment required by EU legislation and performed by an appropriately notified body.

The essential compliance chain therefore remains:

Requirements → Risk Assessment → Technical Measures → Evidence → Conformity Assessment → Declaration of Conformity → CE Marking

These elements have already been covered in the preceding chapters.

23.7 What Should Manufacturers Do in Practice?

The most important practical principle is:

Conformity should remain traceable after the machinery has entered the market.

Manufacturers should therefore assess relevant changes and new information concerning, for example:

• the machinery;
• safety-related components;
• software;
• applicable standards;
• intended use; and
• newly identified safety risks.

This does not mean repeating the entire conformity assessment every time a customer contacts the manufacturer. The important point is to have a structured process for determining when new information or changes could affect conformity.

23.8 Summary

Market surveillance ensures that machinery remains subject to regulatory oversight after it has been made available on the EU market.

For manufacturers, the key points are:

• Technical documentation must be available and defensible.
• Conformity must be demonstrable if requested by an authority.
• New safety information should be assessed.
• Changes to machinery already placed on the market may require a conformity review.
• Non-conformities can lead to corrective measures, withdrawal or recall.

The central practical principle is:

CE marking does not mean that regulatory responsibility simply ends when the machine is shipped to the customer.

Chapter 24: Practical Examples of Machinery Compliance

The previous chapters have described the individual elements of machinery compliance. This chapter brings them together through practical examples.

The purpose is not to repeat the complete conformity assessment process for every machine, but to show how the scope, risk profile, standards, documentation and conformity assessment procedure can change depending on the product.

The examples are based on the scope and definitions of the Machinery Directive and the European Commission’s Guide to the application of the Machinery Directive 2006/42/EC. (EUR-Lex)

24.1 Example 1 – Automated Packaging Machine

Consider an automated packaging machine with:

• an electric drive;
• moving mechanical parts;
• pneumatic actuators;
• guards and interlocked access doors;
• a programmable control system;
• emergency-stop functions.

The machine clearly falls within the general concept of machinery because it consists of linked components, includes moving parts and is intended for a specific application. (EUR-Lex)

The manufacturer would typically need to consider:

• mechanical hazards;
• crushing and shearing;
• unexpected start-up;
• pneumatic energy;
• electrical hazards;
• control-system safety;
• access to dangerous moving parts.

The resulting risk assessment determines which protective measures and standards are relevant.

The important point is that the machine is not assessed simply because it is a “packaging machine.” Its actual design and foreseeable use determine the hazards that have to be addressed.

24.2 Example 2 – Machine With Integrated Robot

A production cell contains:

• a robot;
• a machining or handling process;
• safety fencing;
• access doors;
• safety-related control functions;
• automatic operation.

The individual components may already have been assessed separately, but the completed installation must be considered as a whole where the machines and partly completed machinery are arranged and controlled to function as an integral unit.

The Machinery Directive explicitly includes such assemblies within its definition of machinery. (EUR-Lex)

The manufacturer responsible for the completed cell therefore cannot simply collect the declarations of the individual components and assume that the complete installation is automatically compliant.

The interfaces between the components are particularly important:

• what happens when one machine stops?
• can another machine continue moving?
• can the robot restart unexpectedly?
• does opening an access door stop all relevant hazardous movements?
• are the safety functions coordinated across the complete cell?

The conformity assessment must address the resulting system.

24.3 Example 3 – Machine With Wireless Connectivity

Consider a machine equipped with Wi-Fi or Bluetooth for:

• service access;
• configuration;
• diagnostics;
• software updates; or
• communication with another system.

The wireless function does not remove the machine from the Machinery Directive.

Instead, it becomes an additional feature that may influence the risk assessment.

For example, the manufacturer should consider whether remote access could:

• initiate hazardous movement;
• modify safety-relevant parameters;
• interfere with protective functions; or
• create an unexpected operating condition.

The exact regulatory consequences depend on the technology and implementation and must be assessed against the legislation applicable to the complete product.

24.4 Example 4 – Lifting Machine

A powered lifting machine presents a different risk profile from a conventional production machine.

The manufacturer must consider, among other things:

• lifting loads;
• stability;
• falling loads;
• structural integrity;
• load-control functions;
• foreseeable misuse.

Lifting machinery and related products are specifically addressed within the scope and essential health and safety requirements of the Machinery Directive.

The conformity assessment must therefore reflect the specific hazards associated with lifting operations rather than simply applying generic machinery requirements.

24.5 Example 5 – Partly Completed Machinery

Consider a drive module supplied to another manufacturer.

The module cannot independently perform its intended application and is intended to be incorporated into another machine.

This can fall under the definition of partly completed machinery. The Directive specifically defines partly completed machinery as an assembly that is almost machinery but cannot itself perform a specific application and is intended to be incorporated into machinery or other partly completed machinery. (EUR-Lex)

The regulatory treatment is therefore different from that of completed machinery.

The manufacturer of the partly completed machinery does not simply apply the same conformity route as the manufacturer of a finished machine.

Instead, the applicable documentation and declaration requirements for partly completed machinery must be followed, including the required Declaration of Incorporation and assembly instructions.

The receiving manufacturer then incorporates it into the final machine and addresses the resulting risks as part of the final machinery’s conformity assessment.

24.6 Example 6 – A Machine Assembly

A production line consists of several individual machines supplied by different manufacturers.

If these machines are arranged and controlled so that they function as an integral whole, the complete assembly can itself constitute machinery under the Machinery Directive. (EUR-Lex)

This is a frequent source of confusion.

The question is not simply:

“Does every individual machine have CE marking?”

The more important question is:

Does the completed assembly create a new functional and safety-related system?

If so, the interfaces between the individual machines must be considered in the conformity assessment of the complete assembly.

24.7 Example 7 – Imported Machine From Outside the EU

A manufacturer imports a completed machine from a non-EU country and places it on the EU market.

The fact that the machine was manufactured outside the EU does not eliminate the EU conformity requirements.

Before placing the machine on the EU market, the applicable requirements must be fulfilled and the necessary conformity assessment completed.

The importer also has responsibilities under the applicable EU product legislation.

A CE marking applied by a non-EU manufacturer should therefore not simply be accepted without checking the underlying conformity documentation.

24.8 Example 8 – Modification of an Existing Machine

An existing machine is modified by:

• installing a more powerful drive;
• changing the control system;
• adding a new automatic operating mode; or
• integrating another machine.

The correct question is not simply:

“Was the original machine already CE marked?”

Instead, it must be determined whether the modification creates a situation requiring a new conformity assessment under the applicable rules.

The assessment of modifications was addressed in Chapter 21. The important practical principle is that the regulatory status of the original machine does not automatically determine the status of the modified machine.

24.9 What These Examples Demonstrate

These examples show why machinery compliance cannot be reduced to a checklist of standards.

The same basic compliance principles apply, but the relevant assessment changes according to the product:

Example	Key issue
Automated packaging machine	General machinery safety
Robot cell	Integration and interfaces
Wireless machine	Additional functions and risks
Lifting machine	Lifting-specific hazards
Partly completed machinery	Different regulatory status
Complete production line	Assembly functioning as an integral whole
Imported machine	EU market placement responsibilities
Modified machine	Effect of the modification

The European Commission’s Machinery Directive application guide provides further examples and explanations covering the practical application of the Directive. The current guide is edition 2.3, published in April 2024. (IMIES)

24.10 The Practical Lesson

The most important lesson from these examples is simple:

Start with the actual product and its intended function, not with a predefined list of standards or documents.

The classification of the product determines the regulatory route. Its design and intended use determine the relevant risks. The risk assessment then drives the technical measures, applicable standards and required evidence.

That is why two machines that look similar from the outside can require very different conformity assessments.

For a manufacturer, the correct sequence remains:

Product → Scope → Risks → Requirements → Technical Measures → Evidence → Conformity Assessment → Documentation → CE Marking

The individual elements have already been explained in the preceding chapters; the purpose of these examples is to show how they interact in real-world machinery projects.

25: Transition from the Machinery Directive to Machinery Regulation (EU) 2023/1230

For many years, Machinery Directive 2006/42/EC has been the central legal framework for machinery compliance in the European Union.

With Regulation (EU) 2023/1230 on machinery, this framework is being modernised. The Regulation replaces the Machinery Directive and will generally apply from 20 January 2027.

This does not mean that the entire machinery compliance methodology changes. Many fundamental principles remain the same. However, the new Regulation introduces important changes, particularly for modern, digital and connected machinery.

This chapter therefore focuses on the key differences and their practical impact.

25.1 What Remains the Same?

The basic machinery compliance process remains largely unchanged.

Manufacturers still need to:

• define the product and its intended use;
• perform a risk assessment;
• address the essential health and safety requirements;
• implement appropriate technical measures;
• consider relevant standards;
• compile technical documentation;
• carry out the appropriate conformity assessment;
• prepare an EU Declaration of Conformity;
• and apply the CE marking.

The fundamental process remains:

Product → Risks → Requirements → Technical Measures → Evidence → Conformity Assessment → CE

The new Regulation therefore does not replace the existing compliance methodology. It extends and modernises it.

25.2 The Key Legal Difference: Directive vs. Regulation

The Machinery Directive had to be transposed into national legislation by each EU Member State.

The Machinery Regulation, in contrast, applies directly throughout the EU.

This creates a more harmonised legal framework.

Manufacturers will nevertheless need to update internal procedures, templates and declarations when machinery falls under the new Regulation.

25.3 The 2027 Transition

The key general date is:

20 January 2027

Until then, the Machinery Directive remains the principal framework for machinery placed on the EU market, subject to the applicable transitional provisions.

From this date, the Machinery Regulation becomes generally applicable and replaces the Machinery Directive.

For manufacturers, the important question is therefore not simply when development starts, but:

When will the machinery actually be placed on the market or put into service?

A project developed in 2026 may already need to be assessed against the new Regulation if the machinery will only be placed on the EU market after 20 January 2027.

The transitional provisions must be assessed for the specific project.

25.4 Software Becomes More Important

One of the major developments in the new Regulation concerns software.

Modern machinery may use software for safety-related functions such as:

• motion monitoring;
• safe speed limitation;
• automatic operating modes;
• collision avoidance;
• safety-related decision logic;
• software-based protective functions.

The new Regulation explicitly addresses such functions.

For certain machinery, it is therefore no longer sufficient to assess only the mechanical and electrical design.

Safety-related software must also form part of the conformity assessment.

25.5 Artificial Intelligence and Learning Systems

The Regulation also addresses AI-based safety functions.

A conventional control system normally behaves in a predictable and deterministic way.

Learning or AI-based systems can behave differently because their behaviour may be influenced by data or learning processes.

This creates additional questions:

• Can a safety-related function change itself?
• Could such a change create a new hazard?
• How is the behaviour validated?
• How is it ensured that learning cannot create a dangerous situation?

The Machinery Regulation explicitly addresses these issues.

For manufacturers, AI may therefore need to be considered not simply as a product feature, but as a safety-relevant part of the conformity assessment.

25.6 Cybersecurity Becomes Part of Machinery Safety

For connected machinery, safety risks can no longer be considered exclusively in terms of mechanical or electrical failures.

Unauthorised manipulation could, for example:

• initiate movements;
• modify safety parameters;
• affect protective functions;
• change operating limits;
• or prevent a safe state from being maintained.

The Machinery Regulation therefore addresses protection against manipulation of machinery and safety-related control and software systems.

Cybersecurity becomes a machinery safety issue where interference with digital systems can affect the safety of the machine.

25.7 Digital Instructions

The new Regulation generally permits instructions to be provided in digital form.

This can simplify:

• updates;
• translations;
• version control;
• and the provision of additional technical information.

However, digital provision is subject to specific requirements.

Users must know how to access the instructions, and the information must remain available for the required period.

Additional requirements apply to certain information and, in particular, to machinery intended for non-professional users.

Digital documentation therefore does not simply mean:

“Put a PDF somewhere online and you’re done.”

The method of providing the information itself becomes part of the compliance requirements.

25.8 Digital EU Declaration of Conformity

Under the new Regulation, the EU Declaration of Conformity can also be provided digitally under defined conditions.

Manufacturers can, for example, use:

• web links;
• QR codes;
• machine-readable information

to provide access to the declaration.

As with digital instructions, the manufacturer must ensure that the information remains accessible for the required period.

25.9 Substantial Modifications

The rules concerning substantial modifications also become particularly important.

A modification can become relevant where it:

• creates a new hazard;
• increases an existing risk;
• and consequently requires additional protective measures.

This can result from both physical and digital modifications.

It is particularly relevant to machinery that receives:

• new functions;
• software updates;
• new operating modes;
• or new connections to other machinery.

A person carrying out a substantial modification may consequently assume manufacturer responsibilities under the Machinery Regulation.

The general treatment of modifications was already covered in Chapter 21. Here, the important point is the connection with the new Regulation.

25.10 New Requirements Do Not Automatically Mean New Tests

An important point is often misunderstood:

The new Machinery Regulation does not mean that every machine must undergo a completely new set of tests from 2027 onwards.

The relevant question is which requirements apply to the specific machinery.

Existing technical evidence can remain relevant where it adequately demonstrates compliance with the applicable requirements.

The manufacturer must, however, determine whether the new Regulation introduces additional requirements that need to be addressed.

25.11 What Manufacturers Should Check Now

For new machinery projects, one question should be asked early:

Which legal framework will apply when this machinery is actually placed on the market?

If market introduction is planned on or after 20 January 2027, the Machinery Regulation should already be considered during development.

Particular attention should be given to:

1. applicability of the new Regulation;
2. new or modified essential requirements;
3. safety-related software;
4. AI-based safety functions;
5. cybersecurity;
6. digital documentation;
7. potential future substantial modifications;
8. conformity assessment procedures;
9. technical documentation.

25.12 What About Existing Machinery?

The introduction of the new Regulation does not mean that every machine already on the market must automatically be reassessed.

Relevant factors include:

• when the machinery was placed on the market;
• its existing legal status;
• subsequent modifications;
• and whether those modifications constitute a substantial modification.

Existing machinery must therefore be considered differently from newly developed machinery that will first enter the EU market after 20 January 2027.

25.13 The Practical Impact for Manufacturers

The biggest change is not necessarily the fundamental compliance methodology.

It is that machinery compliance increasingly needs to consider digital functions and digital risks.

A modern machine may effectively be:

Mechanical system + electrical system + control system + software + network + safety functions

Where these elements influence safety, the conformity assessment needs to consider them together.

25.14 Summary

Regulation (EU) 2023/1230 replaces Machinery Directive 2006/42/EC and will generally apply from 20 January 2027.

The fundamental compliance logic remains:

Identify risks → Determine requirements → Reduce risks → Generate evidence → Assess conformity

The new framework places particular emphasis on:

• safety-related software;
• AI-based safety functions;
• cybersecurity;
• digital instructions;
• digital declarations of conformity;
• substantial physical and digital modifications.

For manufacturers, the key practical question is therefore not:

“When do we forget the old Machinery Directive?”

It is:

“Which legal framework applies to our machinery when it is placed on the market, and have we designed the compliance process accordingly?”

The transition from the Machinery Directive to the Machinery Regulation is therefore a product-development issue, not merely an administrative change.

26: Frequently Asked Questions on Machinery Compliance

This chapter addresses practical questions that commonly arise during machinery conformity assessment.

The detailed requirements and the transition to the Machinery Regulation have already been covered in the preceding chapters. The focus here is therefore on the practical questions manufacturers are most likely to encounter during an actual machinery project.

26.1 Does Every Machine Need CE Marking?

No.

CE marking is required where the machinery falls under applicable EU harmonisation legislation that requires CE marking.

For machinery covered by the EU machinery framework, the manufacturer must first determine which legal requirements apply at the time the machinery is placed on the market.

26.2 Does Every Machine Require a Notified Body?

No.

The involvement of a Notified Body depends on the applicable conformity assessment procedure and, in particular, on the classification of the machinery.

For many machines, the manufacturer can carry out the conformity assessment under its own responsibility.

Certain higher-risk machinery, however, may require specific procedures involving a Notified Body.

26.3 Is CE Marking Proof of Conformity?

No.

CE marking is not an independent certificate.

It represents the result of the completed conformity process and the supporting evidence.

Depending on the product, this may include:

• risk assessment;
• technical documentation;
• test and verification results;
• instructions;
• EU Declaration of Conformity;
• conformity assessment records.

26.4 Must Harmonised Standards Be Used?

No.

Manufacturers can generally use other technical solutions, provided the applicable essential requirements are fulfilled.

Harmonised standards nevertheless provide an important advantage because, where properly applied, they can provide a presumption of conformity for the requirements they cover.

They are therefore an important compliance tool, but they should not be the starting point of the assessment.

26.5 Is CE Marking of a Component Sufficient for the Complete Machine?

No.

A CE-marked component can be incorporated into a machine, but its own conformity does not automatically make the complete machine compliant.

The manufacturer of the final machine remains responsible for the conformity of the complete system.

Particular attention should be paid to interfaces between:

• control systems;
• drives;
• safety components;
• protective devices;
• robots;
• and other machines or assemblies.

26.6 Can a Machine Manufactured Outside the EU Be Sold in the EU?

Yes.

The location of manufacture is not decisive.

A machine manufactured outside the EU must comply with the applicable European requirements before being placed on the EU market.

For imported machinery, the respective responsibilities of the importer and other economic operators must also be considered.

26.7 What Happens If an Existing Machine Is Modified?

Not every modification automatically requires a completely new conformity assessment.

The key question is whether the modification affects safety and, in particular, whether it constitutes a substantial modification.

This can become relevant for changes to:

• safety functions;
• control systems;
• software;
• operating modes;
• performance limits.

The detailed treatment of modifications is provided in Chapter 21 and Chapter 25.

26.8 Does a Machinery Assembly Require Its Own Conformity Assessment?

Potentially, yes.

When several machines or partly completed machines are connected and operate together as a functional unit, the resulting assembly may itself need to be assessed as a whole.

The CE markings of the individual machines do not automatically cover the safety of the complete assembly.

In particular, the interfaces and interaction between the machines must be assessed.

26.9 What About Machines with Wi-Fi, Bluetooth or Other Wireless Connections?

The use of wireless communication does not automatically determine which legislation applies.

It can, however, introduce additional requirements.

If a wireless connection can influence safety-related functions, this must be considered in the risk assessment.

Depending on the technology and product, additional EU legislation may also apply.

26.10 Can Instructions Be Provided Digitally?

Yes.

The Machinery Regulation generally permits instructions to be provided in digital form.

The relevant requirements must nevertheless be fulfilled.

In particular, users must know how to access the information, and it must remain available for the required period.

Additional requirements apply to certain machinery and user groups.

26.11 Can the EU Declaration of Conformity Be Provided Digitally?

Yes.

Under defined conditions, the Machinery Regulation allows the EU Declaration of Conformity to be provided digitally.

Manufacturers may, for example, use:

• web addresses;
• QR codes;
• machine-readable information.

The manufacturer remains responsible for ensuring that the declaration remains accessible for the required period.

26.12 Is Cybersecurity Required for Every Machine?

Cybersecurity does not have to be addressed in the same way for every machine.

It becomes particularly relevant where digital systems or communication connections can affect the safety of the machinery.

For a connected machine, for example, manipulation of software or control parameters could directly create a safety risk.

Cybersecurity should therefore form part of the risk assessment where digital manipulation could have safety-related consequences.

26.13 Does the New Machinery Regulation Mean That Machines Must Be Completely Retested?

No, not automatically.

The introduction of the Machinery Regulation does not mean that every machine must undergo an entirely new set of tests from 2027 onwards.

The relevant questions are:

• Which legal framework applies?
• Which requirements are relevant?
• What evidence already exists?
• Are additional requirements introduced by the new Regulation?

Existing technical evidence can remain relevant where it adequately demonstrates compliance with the applicable requirements.

26.14 What About Machinery Placed on the Market Before 20 January 2027?

The new Machinery Regulation does not automatically require every machine already placed on the market to undergo a new conformity assessment.

Relevant factors include the date of placing on the market and any subsequent modifications.

A later substantial modification may, however, trigger additional conformity obligations.

The transitional provisions should always be checked against the specific circumstances of the project.

26.15 What Happens After a Software Update?

Not every software update is automatically a substantial modification.

The impact of the update must be assessed.

An update to a non-safety-related function is different from a change that:

• modifies a safety function;
• changes movement parameters;
• affects protective functions;
• or increases an existing risk.

For safety-related updates, the manufacturer should document what impact was assessed and why the machine remains compliant.

26.16 How Long Must Technical Documentation Be Retained?

The applicable legislation defines the relevant retention periods.

Both the Machinery Directive and the Machinery Regulation generally provide for a 10-year retention period for relevant technical documentation.

In practice, however, documentation should not be managed solely around the statutory minimum period.

Controlled document management throughout the product lifecycle is a much more robust approach.

26.17 What Is One of the Most Common Mistakes in Machinery Projects?

A common mistake is to begin with:

“What test do we need?”

or:

“What certificate do we need?”

A better starting point is:

“What exactly is our product, and what risks arise from its intended use?”

From there, the applicable legislation, requirements, standards and evidence can be determined.

26.18 What Should a Manufacturer Do First When Starting a New Machinery Project?

Do not start with testing.

First establish at least:

1. What exactly is the product?
2. When will it be placed on the market?
3. Which EU legislation applies?
4. What hazards and risks exist?
5. Which conformity assessment procedure is required?
6. What evidence will be needed?

Only then should the detailed testing and documentation plan be developed.

26.19 The Most Important Practical Rule

An efficient machinery compliance process can be reduced to one sequence:

Understand the Product → Determine the Legal Framework → Assess the Risks → Determine the Requirements → Define Technical Measures → Generate Evidence → Assess Conformity → Complete the Documentation → Apply CE Marking

The most important question is therefore not:

“How do we get a CE certificate?”

It is:

“How can we demonstrate, in a traceable way, that our machinery meets the requirements that apply to it?”

This perspective prevents CE compliance from becoming a collection of isolated tests and documents. Instead, it turns compliance into a structured and traceable product process.

Chapter 27: Conclusion

Machinery compliance is not a single test or simply the application of a CE marking. It is the result of a structured process that begins during product development.

The key principles can be summarised as follows.

1. Understand the Product First

Before selecting standards or planning tests, it must be clear:

• What is the product?
• What functions does it perform?
• What is its intended use?
• What reasonably foreseeable misuse is possible?
• What hazards can arise?

An incorrect classification at the beginning can affect the entire compliance process.

2. Determine the Applicable Legislation

Machinery can be subject to several EU legal requirements at the same time.

The applicable legislation must therefore be identified early. Only then can the relevant requirements and conformity assessment procedures be determined correctly.

3. Let the Risks Drive the Technical Measures

The risk assessment is not simply a formal document.

It must reflect the actual hazards of the machinery and lead to appropriate protective measures.

Standards are an important tool, but they do not replace a product-specific assessment.

4. Make the Technical Documentation Traceable

The technical documentation should not merely show what was tested. It should make the compliance decisions understandable:

Which requirements were considered? Why were particular measures selected? How was their effectiveness demonstrated?

This makes the technical documentation a central part of the evidence of conformity.

5. CE Marking Is the Result — Not the Starting Point

CE marking comes at the end of the process.

It is not an independent certification and does not replace the supporting evidence.

The actual compliance work happens behind the CE marking.

6. Compliance Does Not End at Delivery

Changes to hardware, software or intended use can affect conformity.

For modern connected machinery, the entire product lifecycle therefore needs to be considered.

7. The Machinery Regulation Introduces New Considerations

Regulation (EU) 2023/1230 places greater emphasis on modern machinery and technologies.

Software, digital documentation, cybersecurity, artificial intelligence and substantial modifications become increasingly important.

Manufacturers should therefore address these topics during product development rather than waiting until the new Regulation becomes applicable.

The Key Principle

A robust machinery compliance process can ultimately be reduced to one sequence:

Understand the Product → Determine the Scope → Assess the Risks → Determine the Requirements → Develop Technical Solutions → Generate Evidence → Perform the Conformity Assessment → Complete the Documentation → Apply the CE Marking

Following this process systematically can reduce not only regulatory risk, but also late design changes, unnecessary testing and additional costs.

Good compliance does not start with CE marking. It starts with the design of the machine.