1. What Is CE Marking?

The CE marking is a regulatory marking for products that fall under certain EU harmonisation legislation. By affixing the CE marking, the manufacturer declares, under its own responsibility, that the product complies with the applicable legal requirements and that the required conformity assessment has been carried out.

CE marking is therefore not a voluntary quality label and is not a general seal of approval.

What Does CE Marking Mean?

When a product is subject to CE marking requirements, the manufacturer must first determine which EU legislation applies to the product and what requirements arise from it.

Depending on the product, several pieces of legislation may apply simultaneously. An electrical or electronic product, for example, may have to meet requirements relating to:

• Electrical safety
• Electromagnetic compatibility
• Radio
• Hazardous substances
• Machinery or product-specific safety
• Environmental or energy requirements

CE marking therefore does not represent compliance with one particular standard or one particular test. It represents conformity of the product with all applicable CE-related requirements.

CE Marking Is Not “CE Certification”

A common mistake is to say:

“Our product is CE certified.”

There is no general “CE certification.”

The responsibility for conformity lies primarily with the manufacturer. The manufacturer must identify the applicable requirements, carry out the required conformity assessment procedure, prepare the technical documentation, draw up the EU Declaration of Conformity and affix the CE marking.

Depending on the product and applicable legislation, a Notified Body may have to be involved in the conformity assessment. Whether this is required depends on the product and the applicable conformity assessment procedure.

A laboratory test report or a certificate issued by an organisation is therefore not automatically equivalent to CE conformity.

What CE Marking Does Not Mean

The CE marking does not mean, in particular, that:

• the European Union has tested or approved the product;
• a government authority has generally certified the product as “safe”;
• only one specific test was performed;
• the product was manufactured in the EU; or
• an independent certification body was required for every product.

The CE marking also cannot simply be applied as a precautionary measure. It is intended only for products covered by EU legislation that requires CE marking.

Who Is Responsible for CE Compliance?

The manufacturer is generally responsible for the conformity of its product.

This includes:

1. Identifying the applicable EU legislation
2. Determining the product-specific requirements
3. Establishing the required conformity assessment procedure
4. Carrying out the necessary tests and assessments
5. Preparing the technical documentation
6. Drawing up the EU Declaration of Conformity
7. Correctly affixing the CE marking

For products originating outside the EU, additional responsibilities may apply to importers and, where applicable, authorised representatives. These roles will be covered later in this guide.

The Key Point

CE marking is not the starting point of a compliance project.

It is the result of a conformity process:

Understand the product → identify applicable EU legislation → assess the requirements → demonstrate conformity → document the results → prepare the EU Declaration of Conformity → affix the CE marking

That is why the right question is not:

“How do I get a CE certificate?”

but rather:

“Which EU requirements apply to my specific product, and how can I demonstrate conformity with them?”

2. Does My Product Need CE Marking?

Not every product sold in the European Union requires a CE marking.

The first question should therefore not be:

“How do I get CE marking?”

but:

“Is my product covered by EU legislation that requires CE marking?”

CE marking is mandatory only for products covered by specific EU harmonisation legislation that explicitly provides for CE marking. If no such legislation applies, the CE marking must not be affixed.

Which Products Require CE Marking?

CE marking applies to a wide range of product categories. Examples include:

• Electrical and electronic equipment
• Radio equipment
• Machinery
• Toys
• Drones
• Medical devices
• Personal protective equipment
• Certain pressure equipment
• Certain gas appliances
• Batteries
• Measuring and weighing instruments
• Pyrotechnic products
• Recreational craft and watercraft

This is not an exhaustive list. Whether a specific product requires CE marking depends on the legislation applicable to that product and its intended use.

A product can also fall under several EU legal acts at the same time. For example, an electronic product with wireless functionality may need to comply with requirements relating to radio equipment, EMC, hazardous substances and other product-specific legislation.

The manufacturer must address all applicable requirements before applying the CE marking.

How Do You Determine Whether CE Marking Applies?

The starting point is the product itself, not the test laboratory or a particular standard.

The manufacturer should determine:

1. What exactly is the product?
2. What is its intended purpose?
3. How is it operated?
4. Who is the intended user?
5. Does it contain electrical or electronic functions?
6. Does it contain radio functionality?
7. Is it a machine, medical device, toy, measuring instrument or another regulated product?
8. Is it placed on the EU market under the manufacturer’s own name or trademark?
9. Which EU harmonisation legislation covers the product?

Only after this assessment can the applicable legal framework be established.

This distinction is important because a product category alone does not always determine the complete compliance path. The actual function, configuration and intended use can influence which legislation and requirements apply.

What If No CE Legislation Applies?

If a product is not covered by EU legislation requiring CE marking, the manufacturer must not use the CE marking merely to indicate that the product complies with European requirements.

This does not mean that the product is free from regulatory requirements.

Other EU or national requirements may still apply. For example, products outside the scope of CE-marking legislation can still be subject to general product safety requirements.

This is an important distinction:

No CE marking required ≠ no compliance requirements.

What If Several EU Regulations or Directives Apply?

This is common for electrical and electronic products.

For example, a product could potentially fall under several different pieces of EU legislation. The manufacturer must identify each applicable legal act and ensure that the corresponding requirements have been addressed before the CE marking is affixed.

The CE marking then represents conformity with the applicable CE-related EU legislation as a whole, rather than conformity with one individual directive, regulation or standard.

This is one reason why simply asking:

“Which standard do I need?”

is often too early in the process.

The more fundamental question is:

“Which EU legislation applies to my product?”

The standards and conformity assessment procedure can then be determined based on that regulatory framework.

CE Marking vs. National Requirements

EU harmonisation legislation is intended to establish common requirements for products across the EU internal market. Where CE-marking legislation applies and the product complies with the applicable requirements, the CE marking supports the free movement of that product within the EU/EEA framework.

However, manufacturers should not assume that every requirement affecting a product is automatically replaced by CE marking.

Depending on the product and how it is marketed or used, additional requirements may exist, including requirements concerning:

• Environmental obligations
• Waste and recycling
• Packaging
• Language
• National registration schemes
• Market-specific obligations
• Installation or use

These requirements need to be considered separately from the question of whether the product requires CE marking.

The Key Point

The CE process should start with regulatory applicability, not with testing.

Product → Intended use → Applicable EU legislation → Applicable requirements → Conformity assessment → CE marking

If the wrong legislation is identified at the beginning, even a technically successful test program may not provide the evidence needed to demonstrate overall EU conformity.

The first CE question is therefore not “What do I need to test?” — it is “What legislation applies to my product?”

3. Identify the Applicable EU Legislation

Before selecting standards or planning tests, the manufacturer must first determine which EU legislation applies to the specific product.

This is one of the most important steps in the entire CE process. A product can fall under several pieces of legislation at the same time, with each potentially introducing its own requirements and, in some cases, its own conformity assessment procedure.

Why Product Classification Comes First

The regulatory assessment should start with the product and its intended use.

Relevant questions include:

• What is the main function of the product?
• What is it designed to do?
• Who is the intended user?
• Is it sold as a standalone product or as part of another product?
• Does it contain electrical or electronic functions?
• Does it contain a radio function?
• Is it a machine or part of a machine?
• Is it a medical device?
• Is it intended for a specific industrial or professional environment?

These questions can be decisive when determining which legislation needs to be considered.

An incorrect classification at this stage can affect the entire compliance process.

Multiple Pieces of Legislation Can Apply

A common misconception is that every product can be assigned to one single directive or regulation.

In practice, several pieces of EU legislation may apply simultaneously.

For example, an electronic product with Bluetooth functionality could potentially have requirements relating to:

Radio
→ Radio Equipment Directive (RED)

EMC
→ EMC Directive

Electrical Safety
→ Low Voltage Directive, where applicable

Hazardous Substances
→ RoHS

Additional product-specific legislation may also apply depending on the product.

The task is therefore not simply to find one applicable directive, but to establish the complete applicable regulatory framework.

Common EU Legislation for Electrical and Electronic Products

Depending on the product, the following legislation may be relevant.

Radio Equipment Directive (RED)

The Radio Equipment Directive 2014/53/EU applies to certain radio equipment.

It covers, among other things, requirements relating to:

• Health and safety
• Electromagnetic compatibility
• Efficient use of the radio spectrum
• Certain additional requirements applicable to radio equipment

For products using Bluetooth, Wi-Fi, Zigbee, LoRa or other radio technologies, it is therefore important to first determine whether the RED applies.

EMC Directive

The EMC Directive 2014/30/EU applies to equipment that can cause electromagnetic disturbance or whose performance can be affected by such disturbance.

Typical questions include:

• What emissions does the product generate?
• What level of immunity is required?
• Which operating conditions are relevant?
• Which harmonised standards may be applied?

For radio equipment, however, it must first be determined whether the relevant EMC requirements are addressed under the RED rather than the EMC Directive.

Low Voltage Directive

The Low Voltage Directive 2014/35/EU (LVD) applies to certain electrical equipment within defined voltage ranges.

An important point is:

Not every electrical product automatically falls under the LVD.

Whether it applies depends, among other things, on the product and its operating voltages.

Other product-specific legislation may also take precedence or apply instead.

RoHS

The RoHS Directive 2011/65/EU restricts certain hazardous substances in electrical and electronic equipment.

It is particularly relevant to electrical and electronic products and needs to be considered independently of the safety or EMC testing performed.

Successful EMC or safety testing therefore does not automatically demonstrate RoHS compliance.

Machinery Legislation

For machinery, European machinery legislation may apply.

A machine should not simply be treated as an “electrical product.”

Its function, intended use, hazards and product characteristics determine which requirements need to be addressed.

Medical Device Regulation

For medical devices, the Medical Device Regulation (EU) 2017/745 (MDR) may form the central regulatory framework.

In addition to general safety and performance requirements, this can involve requirements relating to:

• Risk management
• Electrical safety
• EMC
• Software
• Clinical evaluation
• Technical documentation

The fact that a medical device contains electrical functions therefore does not mean that the standard compliance approach for a general electrical product is sufficient.

Other Product-Specific Legislation

Depending on the product, additional EU legislation may apply, for example to:

• Toys
• Personal protective equipment
• Pressure equipment
• Measuring instruments
• Energy-related products and ecodesign
• Batteries
• Lifts
• Radio equipment
• Machinery
• Medical devices

The complete assessment must therefore always be product-specific.

How to Deal with Overlapping Legislation

When several pieces of legislation apply, the manufacturer must address the requirements of all applicable legal acts.

This does not necessarily mean that an entirely separate test program is required for every piece of legislation.

A single test or test report may sometimes provide evidence relevant to several parts of the conformity assessment.

For example, certain EMC tests may provide technical evidence that is relevant to multiple requirements.

What matters is that the manufacturer can clearly document:

Which requirement applies, how it was assessed, and which evidence demonstrates conformity.

This is why manufacturers should not work backwards from a test report to determine the applicable legislation.

The correct approach is:

Legislation → Requirements → Standards → Tests → Evidence

rather than:

Test → Test report → Assume the product is CE compliant

Regulatory Classification Is Product-Specific

A particularly important point is that the same technical function can lead to different regulatory requirements depending on the product in which it is used.

For example, the same Bluetooth module could be:

• integrated into a medical device,
• part of a machine,
• integrated into a consumer product, or
• used in a standalone radio product.

The radio technology may be technically identical, but the regulatory context can be significantly different.

The question should therefore always be:

“Which legislation applies to this specific product, in this specific configuration and for this intended use?”

The Key Point

Standards should be selected only after the product’s regulatory framework has been established.

Product → Classification → Applicable EU legislation → Requirements → Standards → Conformity assessment

Starting directly with a search for a standard can result in finding the right test for one aspect of the product while overlooking another applicable regulatory requirement.

4. Determine the Essential Requirements

Once the applicable EU legislation has been identified, the next step is to determine the specific requirements that the product must meet.

EU legislation often sets out essential or fundamental requirements. It does not necessarily prescribe a specific technical solution for every product.

The manufacturer’s task is to apply these legal requirements to the specific product and demonstrate that they have been fulfilled.

What Are “Essential Requirements”?

Essential requirements are the fundamental requirements that a product must meet in order to comply with the applicable legislation.

Depending on the legislation, they may address areas such as:

• Health and safety
• Electromagnetic compatibility
• Radio spectrum
• Protection against electrical hazards
• Protection against mechanical or thermal hazards
• Restricted substances
• Environmental and energy requirements
• Other product-specific characteristics

Which requirements actually apply depends on the product and the applicable legislation.

From Legal Requirements to Technical Requirements

An important step is translating relatively general legal requirements into specific technical requirements for the product.

For example, legislation may require that a product:

does not generate electromagnetic disturbances that would prevent other equipment from operating as intended.

This can then be translated into specific technical requirements that may be assessed using relevant EMC standards and testing.

Similarly, a general safety requirement may result in the need to evaluate:

• Insulation distances
• Protective measures
• Temperature limits
• Mechanical protection
• Protection against electrical energy

The standard is therefore a tool for the technical assessment — it is not itself the legislation.

Not Every Requirement Is a Test Requirement

A common mistake is to assume that every legal requirement automatically requires a laboratory test.

That is not always the case.

Depending on the requirement, conformity may be demonstrated through:

• Testing
• Calculations
• Technical assessments
• Design documentation
• Risk assessments
• Inspections
• Manufacturer information
• Technical documentation

A test report is therefore only one part of the overall evidence of conformity.

All Applicable Requirements Must Be Considered

For a product subject to multiple pieces of legislation, the manufacturer should be able to trace each relevant requirement:

1. Which legislation contains the requirement?
2. Is the requirement relevant to the specific product?
3. How is it assessed?
4. Which standard or technical solution is used, where applicable?
5. What evidence demonstrates conformity?

This can, for example, be structured in a compliance matrix:

Legislation	Requirement	Relevance	Assessment Method	Evidence
RED	Safety	Relevant	Standard / Assessment	Test report
RED	EMC	Relevant	EMC testing	Test report
RED	Spectrum	Relevant	RF testing	RF report
RoHS	Restricted substances	Relevant	Material assessment	Supplier documentation
Product-specific	Safety requirement	Relevant	Risk assessment / testing	Technical documentation

A structure like this helps ensure that requirements are not overlooked, while also avoiding unnecessary testing.

Intended Use Is Critical

Requirements should not be considered independently of the product’s actual intended use.

Relevant factors may include:

• Intended use
• Intended users
• Operating conditions
• Environmental conditions
• Reasonably foreseeable misuse
• Different product configurations
• Accessories
• Software and operating modes

A product can therefore remain technically unchanged while requiring a different regulatory assessment because its intended use or configuration has changed.

How Should Compliance Be Documented?

The manufacturer should be able to document how the applicable requirements have been addressed.

Depending on the product, this may include:

• Applied standards
• Test reports
• Calculations
• Risk assessments
• Technical drawings
• Schematics
• Bills of materials
• Material information
• Software information
• Manufacturer declarations
• Technical assessments

These records will later form an important part of the technical documentation.

The Key Point

CE conformity is not achieved simply by passing a certain number of tests.

What matters is that the manufacturer can demonstrate:

Which requirements apply → how they were assessed → and what evidence demonstrates conformity.

The logical sequence is therefore:

Legislation → Requirements → Technical assessment → Evidence

Only then should the specific standards and tests be selected.

5. Harmonised Standards and Presumption of Conformity

Once the applicable EU legislation and its requirements have been identified, the next step is to determine which standards can be used to demonstrate conformity.

For many manufacturers, this is where the CE process becomes highly technical. However, an important distinction must be made:

EU legislation defines the legal requirements. Standards provide technical methods for demonstrating that those requirements have been addressed.

What Is a Harmonised Standard?

A harmonised standard is a European standard developed by a recognised European Standards Organisation — CEN, CENELEC or ETSI — in response to a standardisation request from the European Commission.

Harmonised standards can provide manufacturers with a practical way to demonstrate conformity with relevant requirements of EU legislation.

However, simply having an EN standard does not automatically make it a harmonised standard for CE purposes.

This distinction is important:

European standard ≠ automatically harmonised standard

For a standard to provide the relevant legal effect under EU harmonisation legislation, its reference must be published in the Official Journal of the European Union (OJEU).

What Is the Presumption of Conformity?

One of the main benefits of using a harmonised standard is the presumption of conformity.

Where the reference of a harmonised standard has been published in the Official Journal and the standard addresses the relevant requirements, applying that standard can provide a presumption that the corresponding requirements covered by the standard have been met.

This does not mean:

“We used a harmonised standard, therefore the entire product is CE compliant.”

The presumption applies only to the requirements and scope covered by the relevant standard.

A product may still have other requirements that need to be addressed through additional standards, assessments, calculations, testing or other evidence.

Harmonised vs. Non-Harmonised Standards

A manufacturer may encounter several types of standards during a compliance project:

• Harmonised European standards
• European standards that are not harmonised
• International IEC or ISO standards
• Company or industry specifications
• National standards
• Other technical specifications

Not all of these have the same regulatory significance.

A non-harmonised standard can still be technically useful and may help demonstrate that a product meets a particular requirement. However, it does not automatically provide the same presumption of conformity that applies to a harmonised standard whose reference has been published in the OJEU.

Publication in the Official Journal Matters

The status of a standard should therefore not be determined solely by looking at the title or publication date of the standard itself.

The manufacturer should check:

1. Is the standard relevant to the applicable EU legislation?
2. Is it actually harmonised for that legislation?
3. Has its reference been published in the OJEU?
4. Does the published reference include limitations or restrictions?
5. Has a previous version ceased to provide presumption of conformity?
6. Does the standard cover the specific product and requirements being assessed?

The European Commission publishes consolidated information about harmonised standards and their publication status. However, the Commission notes that these summary lists are provided for information and that publication in the Official Journal is what gives the relevant legal effect.

This is particularly important when standards are updated or replaced.

A newer version of a standard may exist while an older version remains relevant for a particular regulatory transition — or a standard may have been withdrawn from the OJEU even though the document itself is still commercially available.

Can Manufacturers Use Alternative Technical Solutions?

Yes.

The use of harmonised standards is generally voluntary. Manufacturers are not normally required to use a particular harmonised standard if they can demonstrate compliance with the applicable legal requirements using another appropriate technical solution.

However, choosing not to use a harmonised standard can change the compliance strategy.

Without the presumption of conformity provided by the applicable harmonised standard, the manufacturer may need to provide other technical evidence demonstrating that the relevant legal requirements have been fulfilled.

This can make the conformity assessment more complex and may require additional technical justification.

Therefore:

“Not mandatory” does not mean “irrelevant.”

Harmonised standards are often the most practical route because they provide established technical methods and, where applicable, a presumption of conformity.

Selecting the Correct Standard

Choosing a standard should not simply be a matter of finding one whose title appears to match the product.

The manufacturer should consider:

• Product type
• Intended use
• Technology
• Operating environment
• Applicable legislation
• Product configuration
• Applicable frequency bands
• Interfaces and connections
• Power supply
• Accessories
• Product variants
• Applicable edition of the standard
• OJEU publication status

For example, an electronic product may require several different standards covering different aspects of its compliance.

A wireless product might require standards addressing:

Radio performance → EMC → Safety → RF exposure → other applicable requirements

No single standard necessarily covers the entire CE assessment.

A Standard Is Not the Same as a Legal Requirement

This distinction is worth repeating.

The legal framework may state:

The product must meet a particular essential requirement.

The standard may then provide:

A defined technical method for assessing that requirement.

The manufacturer should therefore avoid treating the standard itself as the complete regulatory framework.

The correct relationship is:

EU legislation → Essential requirements → Appropriate standards → Technical assessment → Evidence of conformity

The Key Point

A harmonised standard can be one of the most valuable tools in a CE compliance project because it can provide a presumption of conformity for the requirements it covers, provided its reference has the appropriate publication status in the Official Journal.

But using a harmonised standard does not automatically make the entire product compliant.

The manufacturer still needs to determine:

Which requirements apply → which standards address them → whether those standards are applicable and current → and what additional evidence is needed for everything else.

That is why standards selection is a regulatory assessment, not simply a search for a test standard.

6. Choosing the Conformity Assessment Procedure

Once the applicable EU legislation, essential requirements and relevant standards have been identified, the manufacturer must determine which conformity assessment procedure is required for the product.

Conformity assessment is the process used to demonstrate and document that a product meets the applicable requirements. Depending on the product and the applicable legislation, the manufacturer may be able to carry out the assessment under its own responsibility, or the involvement of a Notified Body may be required.

What Is Conformity Assessment?

Conformity assessment comprises the procedures used to determine and document whether a product meets the applicable requirements.

Depending on the product, this may involve:

• Internal technical assessments
• Calculations
• Risk assessments
• Testing
• Technical documentation
• Quality management systems
• Assessment by a Notified Body

The applicable procedure is determined not simply by the product or the standards used.

The key factor is the applicable EU legislation.

When Can the Manufacturer Assess Conformity Itself?

For many products, the manufacturer can carry out the required conformity assessment under its own responsibility.

This does not mean that the manufacturer cannot use external laboratories or consultants, or that external testing is unnecessary.

It means that the applicable legislation does not require a Notified Body to perform the conformity assessment.

Depending on the product, this may involve:

• Identifying the applicable requirements
• Selecting appropriate harmonised standards
• Performing or commissioning tests
• Conducting technical assessments
• Completing a risk assessment
• Preparing the technical documentation
• Drawing up the EU Declaration of Conformity

The manufacturer remains responsible for the conformity of the product.

When Is a Notified Body Required?

For certain products or under certain conformity assessment procedures, a Notified Body must be involved.

A Notified Body is an organisation designated by an EU Member State and notified to the European Commission to perform specific conformity assessment activities.

An important point is:

Not every CE-marked product requires a Notified Body.

Whether one is required depends on the applicable EU legislation and the conformity assessment procedure specified by that legislation.

For example, certain product classes, risk levels or technical characteristics may require an independent assessment.

Conformity Assessment Procedures and Modules

EU legislation may provide for different conformity assessment procedures or modules.

These can involve different combinations of:

• Internal production control
• EU-type examination
• Product testing
• Production control
• Quality management systems
• Surveillance by a Notified Body

The applicable procedure is therefore not simply a choice made by the manufacturer.

The manufacturer must first identify the applicable legislation and then determine which conformity assessment procedure that legislation requires.

Can a Manufacturer “Self-Certify”?

An important distinction is needed here.

For certain products, a manufacturer can assess and declare conformity itself.

This does not mean that the manufacturer issues an independent “CE certificate” to itself.

The manufacturer:

• assesses conformity,
• prepares the technical documentation,
• draws up the EU Declaration of Conformity, and
• affixes the CE marking when all applicable requirements have been fulfilled.

If the applicable legislation requires a Notified Body, however, the manufacturer cannot simply replace that involvement with its own declaration.

The Conformity Assessment Procedure Is Determined by the Legislation

A common mistake is to plan the testing first and only afterwards determine which conformity assessment procedure applies.

The order should be the other way around:

Applicable legislation → Conformity assessment procedure → Requirements → Standards → Tests and evidence

This is particularly important because two products with similar technical characteristics may require different conformity assessment procedures if they fall under different legislation or product categories.

The Role of a Test Laboratory

A test laboratory and a Notified Body are not automatically the same thing.

A laboratory may, for example, perform testing against a particular standard and issue a test report.

Whether a Notified Body is required, however, is a question of the legally applicable conformity assessment procedure.

Manufacturers should therefore not assume:

“We have a laboratory test report, so the required conformity assessment is complete.”

A test report is technical evidence. Whether it is sufficient to fulfil the complete conformity assessment procedure depends on the applicable regulatory framework.

The Key Point

The applicable EU legislation determines the conformity assessment procedure.

The important question is therefore not:

“Do I need a certificate?”

but:

“Which conformity assessment procedure does the legislation applicable to my product require?”

Only once this has been established can the manufacturer reliably determine what role the manufacturer, a test laboratory and, where applicable, a Notified Body play in the CE compliance process.

7. Testing and Technical Evaluation

Testing is an important part of many CE compliance projects, but testing alone does not demonstrate overall CE conformity.

The purpose of testing is to generate technical evidence showing that specific requirements have been addressed. The extent and type of testing depend on the product, the applicable legislation, the selected standards and the conformity assessment procedure.

What Role Do Laboratories and Test Reports Play?

A test laboratory can provide valuable technical evidence by evaluating a product against specified test methods or standards.

Depending on the product, testing may address areas such as:

• Electrical safety
• Electromagnetic emissions
• Electromagnetic immunity
• Radio performance
• Radio spectrum requirements
• RF exposure
• Environmental or mechanical characteristics
• Product-specific safety requirements

The resulting test report can become an important part of the technical documentation.

However:

A test report is evidence of testing — it is not automatically evidence of complete CE conformity.

The manufacturer still needs to determine whether all applicable legal requirements have been addressed.

When Is Testing Required?

Whether testing is required depends on the applicable legislation and the requirements being assessed.

Some requirements can be demonstrated through testing, while others may be addressed through:

• Calculations
• Technical analysis
• Risk assessment
• Design documentation
• Component information
• Material documentation
• Inspection
• Other technical evidence

The manufacturer should therefore avoid starting with:

“Which tests do we need?”

A better approach is:

“Which requirements need to be demonstrated, and what is the appropriate way to demonstrate each one?”

For some requirements, testing will be the appropriate method. For others, it may not be.

Testing Against Harmonised Standards

Where appropriate harmonised standards are available, they often provide established test methods for evaluating specific requirements.

For example, an electronic product may require assessment of:

Emissions → Immunity → Safety → Radio performance → RF exposure

The applicable standards and test methods depend on the product and regulatory framework.

It is therefore important to confirm that:

• the correct standard has been selected;
• the standard applies to the product;
• the relevant requirements are covered;
• the appropriate version is being used;
• the product configuration tested is representative of the final product.

Simply testing against a familiar standard is not enough.

Can Existing Test Reports Be Used?

Existing test reports can sometimes provide useful evidence, but their applicability needs to be assessed.

This is particularly relevant when a product includes:

• Pre-certified radio modules
• Previously tested components
• Existing power supplies
• Product variants
• Accessories
• Previously tested configurations

A previous report should not automatically be treated as evidence for the new or modified product.

The manufacturer should consider whether the tested configuration is representative of the product being placed on the market.

Relevant differences can include:

• PCB layout
• Components
• Enclosure
• Cables
• Power supply
• Antenna
• Antenna position
• Operating modes
• Firmware
• Radio parameters
• Product configuration

The question is therefore not simply:

“Do we have a test report?”

but:

“Does this test report provide relevant evidence for the product and configuration we are placing on the market?”

Component and Module Test Reports

Using pre-tested or certified components can reduce the amount of work required for the final product, but it does not automatically establish conformity of the complete product.

This is particularly important for radio modules.

A module may have been tested or certified in a specific configuration, but integrating it into a host product can change factors such as:

• Antenna configuration
• RF environment
• PCB layout
• Power supply
• Digital circuitry
• Enclosure
• Cable configuration
• Simultaneous transmission conditions

The final product therefore needs to be assessed based on its actual configuration and applicable requirements.

What Testing Does — and Does Not — Demonstrate

A successful test demonstrates that the product met the specified test criteria under the defined test conditions.

It does not automatically demonstrate that:

• all applicable EU legislation has been identified;
• all essential requirements have been addressed;
• all applicable standards have been considered;
• the technical documentation is complete;
• the risk assessment is adequate;
• the Declaration of Conformity is correct; or
• the product is compliant with every applicable requirement.

This distinction is fundamental to the CE process.

Passing the tests is not the same as completing the conformity assessment.

Pre-Compliance Testing vs. Formal Compliance Testing

Pre-compliance testing is performed before formal laboratory testing to identify potential problems early.

It can be particularly useful for:

• EMC emissions
• EMC immunity
• RF emissions
• RF performance
• RF exposure
• Other technically measurable characteristics

The objective is not necessarily to reproduce the complete formal laboratory setup.

Instead, pre-compliance testing can help answer:

“Are there obvious problems that we should address before entering formal testing?”

Finding an issue during pre-compliance can allow the manufacturer to make changes before the formal test campaign, potentially reducing:

• Retesting
• Development delays
• Laboratory costs
• Design changes late in the project

However, pre-compliance measurements should not automatically be treated as a replacement for the formal conformity assessment required for the product.

A Practical Approach

A useful sequence can be:

Regulatory assessment → Test plan → Pre-compliance testing where appropriate → Design corrections → Formal testing → Technical documentation

This approach can help manufacturers identify problems before they become expensive certification issues.

The Key Point

Testing is an important source of technical evidence, but it is only one part of the CE compliance process.

The manufacturer needs to establish:

What must be demonstrated → how it should be evaluated → what testing is required → whether the results represent the final product → and how the evidence fits into the overall technical documentation.

The goal should therefore not be simply to pass a test, but to build a complete and defensible body of evidence demonstrating conformity.

8. Risk Assessment

A risk assessment is an important part of the CE compliance process for many products. It helps the manufacturer identify relevant hazards, evaluate the associated risks and determine whether the measures implemented in the product are sufficient to address them.

Risk assessment should not be treated as a document that is created only at the end of the project. It should support the design and conformity assessment process from an early stage.

The European Commission identifies the outcome of risk analysis and assessment as part of the technical documentation manufacturers must maintain.

Why Is Risk Assessment Important?

The purpose of a risk assessment is to answer questions such as:

• What hazards can arise from the product?
• Who could be exposed to them?
• Under which operating conditions?
• What could happen if a component or function fails?
• What reasonably foreseeable misuse needs to be considered?
• Which protective measures are required?
• Have the remaining risks been adequately addressed?

Depending on the product, hazards may include:

• Electrical hazards
• Mechanical hazards
• Thermal hazards
• Fire
• Radiation
• Electromagnetic effects
• Chemical hazards
• Software-related hazards
• Functional or operational hazards

The relevant hazards depend on the product, its intended use and the applicable legislation.

Risk Assessment and Conformity Assessment

Risk assessment is not a replacement for testing or other forms of conformity assessment.

Instead, it helps determine which risks need to be addressed and how they should be controlled.

For example, a risk assessment may identify a potential electrical hazard. The manufacturer may then need to address that hazard through a combination of:

• Product design
• Protective measures
• Appropriate components
• Insulation
• Safety distances
• Testing
• Instructions and warnings

The resulting evidence can then form part of the technical documentation.

This creates an important connection:

Hazard → Risk → Risk reduction → Verification → Documentation

Risk Assessment and Standards

Standards can provide valuable methods for identifying and addressing specific risks.

However, the manufacturer should not assume that simply applying a standard automatically replaces the need to understand the risks of the specific product.

The manufacturer should consider whether:

• the standard actually applies to the product;
• all relevant hazards are covered;
• the product has operating conditions outside the standard’s assumptions;
• additional risks arise from specific functions or configurations;
• modifications have introduced new hazards.

A product can therefore comply with the relevant test requirements of a standard while still requiring additional consideration of product-specific risks.

When Should the Risk Assessment Be Performed?

Ideally, risk assessment begins during product development, rather than after testing has been completed.

Early risk assessment can influence:

• Component selection
• Circuit design
• Mechanical construction
• Protective measures
• Software functions
• User interfaces
• Warnings and instructions
• Test planning

It can also help identify potential compliance problems before they become expensive design changes.

The risk assessment should then be reviewed when the product changes.

Changes such as a new:

• component,
• power supply,
• enclosure,
• battery,
• accessory,
• software function,
• operating mode,
• radio configuration

can potentially introduce new hazards or change existing risks.

What Should Be Documented?

The exact content depends on the product and applicable legislation, but the risk assessment should provide a clear and traceable rationale for the conclusions reached.

Depending on the product, this may include:

• Identified hazards
• Risk estimation
• Operating conditions considered
• Foreseeable misuse
• Protective measures
• Risk reduction measures
• Verification of those measures
• Remaining risks
• Warnings or instructions
• References to applicable standards

The important point is that the documentation should demonstrate how the manufacturer arrived at its conclusions.

A risk assessment should therefore not simply state:

“No significant risks identified.”

It should show why the identified risks were considered acceptable and how the relevant hazards were addressed.

Risk Assessment as Part of the Technical Documentation

The risk assessment is not a standalone document that exists independently of the rest of the CE file.

It should connect with other technical evidence, including:

• Product design
• Applied standards
• Test reports
• Safety calculations
• Technical drawings
• Instructions
• Warnings
• Software documentation
• Other conformity evidence

This creates a traceable relationship between the product’s risks and the measures used to control them.

ScopeRight Risk Assessment Wizard

For manufacturers who want to structure this process, ScopeRight provides a Risk Assessment Wizard that helps organize the assessment of product-related risks.

ScopeRight Risk Assessment Wizard

The wizard is intended to support the assessment process; it does not replace the manufacturer’s responsibility for determining and documenting the risks of the specific product.

The Key Point

A risk assessment should not be treated as paperwork required to complete the CE file.

It should be part of the reasoning behind the product’s compliance:

Identify hazards → assess risks → reduce risks → verify the measures → document the results

And because the risk profile can change when the product changes, the risk assessment should be reviewed whenever relevant changes are introduced.

9. Product Safety and Safety Requirements

In addition to performing a risk assessment, the manufacturer must ensure that the specific safety requirements of the applicable EU legislation are addressed for the product.

It is important to distinguish between risk assessment and product safety:

• Risk assessment identifies and evaluates the hazards associated with the product.
• Safety assessment determines which design, technical and organisational measures are needed to reduce those risks and fulfil the applicable requirements.

The two are closely connected, but they are not the same.

What Does Product Safety Mean in the CE Context?

Product safety covers the measures intended to ensure that a product does not present unacceptable risks to people or other protected interests when used as intended and under reasonably foreseeable conditions.

Depending on the product, relevant hazards may include:

• Electrical hazards
• Fire and overheating
• Mechanical hazards
• Thermal hazards
• Radiation
• Hazardous energy
• Chemical hazards
• Battery-related risks
• Software- or function-related safety risks

Which aspects are relevant depends on the specific product and the applicable legislation.

Electrical Safety

For electrical and electronic products, areas that may need to be assessed include:

• Protection against electric shock
• Insulation
• Protective earthing and grounding
• Creepage and clearance distances
• Dielectric strength
• Leakage and touch currents
• Overcurrent protection
• Temperature
• Protection against fire
• Protection against hazardous energy

The applicable requirements and test methods depend, among other things, on the product type, power supply, intended use and applicable safety standard.

Electrical safety testing should therefore not be considered independently of the product.

Mechanical and Thermal Safety

Products without high electrical voltages can still present safety risks.

Depending on the product, these may include:

• Moving parts
• Crushing or shearing points
• Sharp edges
• Instability
• Overheating
• Hot surfaces
• Mechanical failure
• Component breakage
• Insufficient enclosure strength

For machinery and other products with moving or mechanical functions, additional product-specific safety requirements may apply.

Protection Against Reasonably Foreseeable Misuse

The assessment should not be limited exclusively to the intended use.

Depending on the applicable regulatory framework, the manufacturer may also need to consider how the product could be reasonably foreseeably misused.

Examples may include:

• Incorrect operation
• Incorrect installation
• Use of an unsuitable power supply
• Incorrect assembly
• Removal of a protective device
• Use with unintended accessories
• Operation outside specified environmental conditions

The resulting risks can then be addressed through the risk assessment and product design.

Safety Requirements Are Not Always Test Requirements

Product safety compliance does not necessarily mean simply passing a series of laboratory tests.

Safety requirements may be addressed and demonstrated through a combination of:

• Design
• Selection of suitable components
• Protective measures
• Calculations
• Material selection
• Risk assessment
• Testing
• Warnings
• Instructions for use

A test report can therefore provide important safety evidence, but it is not automatically the complete safety assessment.

Product-Specific Safety Standards

Different product categories are covered by different safety standards.

Examples include:

• IEC 62368-1 for certain audio/video, information and communication technology equipment
• IEC 60601-1 for medical electrical equipment
• IEC 61010-1 for certain measurement, control and laboratory equipment
• Other product-specific safety standards

Which standard can or should be applied depends on the product classification and regulatory framework.

The manufacturer should therefore not simply select the most familiar safety standard.

Connecting Risk Assessment, Safety and Testing

These three areas should be considered as a connected process:

Identify hazard

↓

Assess risk

↓

Define protective measure

↓

Implement technically

↓

Verify effectiveness

↓

Document evidence

This makes the safety assessment traceable and allows it to be connected to the technical documentation.

The Key Point

Product safety is not simply:

“The product passed the safety test.”

The more important question is:

“Have the relevant safety risks of the specific product been identified, adequately reduced and supported by appropriate evidence?”

Risk assessment, product design, safety requirements and testing should therefore be treated as connected parts of the same compliance process.

10. Technical Documentation / Technical File

The technical documentation is the central body of evidence in the CE conformity process. It should allow the manufacturer to demonstrate how the conclusion was reached that the product complies with the applicable requirements.

The European Commission requires manufacturers to draw up and keep technical documentation available. It must enable the conformity of the product with the applicable requirements to be assessed.

There is no single identical documentation package for every product. The exact content depends on the applicable EU harmonisation legislation and the specific product.

What Is Technical Documentation?

Technical documentation — often referred to as a Technical File — brings together the technical information needed to assess and demonstrate product conformity.

It should make it possible to understand:

• What is the product?
• What is it intended to do?
• How was it designed?
• Which legislation applies?
• Which standards were used?
• Which risks were identified?
• How were the requirements assessed?
• Which tests were performed?
• Which technical solutions were implemented?
• Why can the manufacturer declare conformity?

The technical documentation must generally be available when the product is placed on the market. Under the Blue Guide, it is generally required to be retained for ten years from the placing on the market of the product concerned, unless the applicable EU legislation specifies a different period.

What Should the Technical Documentation Contain?

The exact content depends on the applicable legislation. Typically, it may include the following.

1. Product Description

The documentation should clearly identify the product.

This may include:

• Product name
• Model or type
• Variants
• Series or product family
• Intended use
• Technical characteristics
• Functional description

The description should be detailed enough to establish which specific product has been assessed.

2. Design and Technical Information

Depending on the product, this may include:

• Technical drawings
• Schematics
• Block diagrams
• PCB information
• Mechanical drawings
• Bills of materials
• Relevant components
• Photographs
• Software or firmware information
• Interfaces
• Product variants

The documentation should provide sufficient information to understand the product’s design, manufacture and operation.

3. Applicable EU Legislation

The technical documentation should clearly identify which EU legislation applies to the product.

Depending on the product, this may include:

• RED
• EMC Directive
• Low Voltage Directive
• RoHS
• Machinery legislation
• Medical Device Regulation
• Other product-specific legislation

This creates the connection between the regulatory assessment and the technical evidence.

4. Applied Standards

The documentation should also identify:

• Which standards were applied
• Which edition was used
• Which requirements they address
• Whether a standard was applied fully or partially
• Which alternative technical solutions were used, where applicable

Where harmonised standards are used, it should also be possible to establish which essential requirements are addressed by those standards.

5. Risk Assessment

The risk assessment is an important part of the technical documentation.

It should provide a traceable connection between:

Hazard → Risk → Protective measure → Verification

The risk assessment should correspond to the actual product configuration and intended use.

6. Test Reports and Technical Evidence

Test reports are often an important part of the technical documentation.

Depending on the product, this may include:

• Safety test reports
• EMC test reports
• Radio test reports
• RF exposure assessments
• Pre-compliance results
• Material evidence
• Calculations
• Technical assessments
• Component or module evidence

Traceability is important:

Which test report demonstrates which requirement?

A folder full of test reports is not necessarily good technical documentation if it is unclear which requirements those reports actually address.

Product Variants and Configurations

The technical documentation should cover the product variants that are actually placed on the market.

This is particularly important when products differ in areas such as:

• Hardware
• Radio modules
• Antennas
• Power supplies
• Enclosures
• Software
• Firmware
• Accessories
• Operating modes
• Country- or frequency-specific configurations

Not every variant automatically requires an entirely new compliance project. At the same time, it should not simply be assumed that an existing assessment applies to every new variant.

The documentation should therefore make it clear which variants are covered by the available evidence and why.

Technical Documentation Must Be Kept Up to Date

Technical documentation is not a document that is created once and then permanently archived.

When the product changes, the manufacturer should assess whether the change affects the conformity assessment.

This may be relevant for changes to:

• Components
• PCB
• Power supply
• Battery
• Radio module
• Antenna
• Firmware
• Enclosure
• Accessories
• Operating conditions

Depending on the change, additional assessment or testing may be necessary.

The technical documentation should then be updated accordingly.

What Should the Technical Documentation Demonstrate?

The technical documentation should not simply be a collection of documents.

It should provide a traceable chain of reasoning:

Product → Applicable legislation → Requirements → Standards → Risk assessment → Technical measures → Testing → Evidence → Conformity

This connection is critical.

If, for example, a market surveillance authority asks:

“Why do you consider this product compliant?”

the technical documentation should provide a clear and traceable answer.

Does the Entire Technical Documentation Have to Be Public?

No.

The technical documentation generally needs to be made available to the relevant authorities. It is not the same as the EU Declaration of Conformity, which has separate availability requirements.

Confidential technical information and trade secrets may also form part of the technical documentation.

What matters is that the required information can be made available to the competent authorities within the applicable framework.

The Key Point

Technical documentation is not simply the “folder containing the test reports.”

It is the technical evidence explaining why the manufacturer can declare conformity for the product.

Good technical documentation should therefore answer systematically:

What was assessed? → Which requirements apply? → How were they assessed? → What evidence exists? → Why is that evidence sufficient?

This is why technical documentation should be built throughout the compliance process — not assembled at the last minute before affixing the CE marking.

11. EU Declaration of Conformity (DoC)

The EU Declaration of Conformity (DoC) is the manufacturer’s formal declaration that the product complies with the applicable EU legislation.

It is an essential part of the CE process and is drawn up after the required conformity assessment has been completed. By signing the DoC, the manufacturer takes responsibility for the product’s conformity with the applicable requirements.

The DoC should therefore not be treated as a simple administrative formality.

It is the document that connects the completed conformity assessment with the manufacturer’s legal declaration of conformity.

What Is the EU Declaration of Conformity?

The EU Declaration of Conformity is a formal document in which the manufacturer declares, under its sole responsibility, that the identified product complies with the applicable EU legislation.

The European Commission describes the DoC as one of the manufacturer’s core CE responsibilities, together with conformity assessment, technical documentation and affixing the CE marking.

The exact requirements for the DoC depend on the applicable legislation. Different EU directives and regulations may specify different mandatory elements or formats.

Who Signs the Declaration?

The EU Declaration of Conformity is issued by the manufacturer or, where applicable, by the authorised representative acting on the manufacturer’s behalf.

The person signing the declaration must have the appropriate authority to legally bind the manufacturer.

The signature is therefore more than an administrative step:

By signing the DoC, the manufacturer formally assumes responsibility for the declared conformity.

What Must the EU Declaration of Conformity Contain?

The exact content depends on the legislation applicable to the product.

Typically, the declaration includes information such as:

• Manufacturer’s name and address
• Product identification
• Model, type or other identifying information
• A statement declaring conformity
• The applicable EU legislation
• Relevant harmonised standards or other technical specifications, where applicable
• Identification of the product sufficient to ensure traceability
• Details of a Notified Body, where applicable
• Date and place of issue
• Name and function of the person authorised to sign
• Legally binding signature

The European Commission specifically notes that the DoC must include manufacturer details, essential product characteristics, the Notified Body identification number where applicable, and a legally binding signature.

The exact wording and structure should always be checked against all legislation applicable to the specific product.

One Product Can Be Subject to Multiple Pieces of Legislation

A product may need to comply with several EU directives or regulations simultaneously.

For example, an electronic product could potentially be subject to:

• RED
• EMC Directive
• RoHS
• Low Voltage Directive, where applicable
• Product-specific legislation

The EU Declaration of Conformity should reflect the applicable legislation for the actual product.

This is important because the DoC is not simply a declaration that the product passed a particular test.

It is a declaration of conformity with the relevant legal requirements.

DoC vs. Test Report vs. Certificate

These documents serve different purposes.

Test Report

A test report documents the results of a specific technical assessment or test.

Certificate

A certificate may be issued by a third party, such as a Notified Body, where the applicable conformity assessment procedure requires or permits such certification.

EU Declaration of Conformity

The DoC is the manufacturer’s legal declaration of conformity.

Therefore:

Test report ≠ certificate ≠ EU Declaration of Conformity

A manufacturer may have several test reports and certificates as evidence supporting the conformity assessment, but the manufacturer is still responsible for issuing the DoC where required.

The DoC Must Match the Actual Product

The Declaration of Conformity should correspond to the product that is actually being placed on the market.

This becomes particularly important when the product changes.

Changes to:

• Hardware
• Components
• Radio modules
• Antennas
• Power supplies
• Firmware
• Software
• Product configuration
• Accessories

may affect the applicable requirements or the evidence supporting conformity.

The manufacturer should therefore determine whether the existing conformity assessment and DoC remain valid.

The DoC should be kept up to date where the applicable legislation requires this.

Language Requirements

The EU Declaration of Conformity must be translated into the language or languages required by the Member State where the product is placed on or made available on the market, as specified by the applicable legislation.

This means that manufacturers selling across multiple EU markets should consider the language requirements applicable to their products and markets.

The DoC Comes at the End — Not the Beginning

A common mistake is to create the Declaration of Conformity at the beginning of a project and simply update it later.

The more logical sequence is:

Applicable legislation → Requirements → Standards → Risk assessment → Conformity assessment → Testing → Technical documentation → EU Declaration of Conformity → CE marking

The DoC should reflect the completed compliance assessment, not serve as a substitute for it.

ScopeRight Declaration of Conformity DOC Generator

Creating a compliant DoC can be time-consuming, particularly when a product is subject to multiple pieces of EU legislation.

ScopeRight provides a Declaration of Conformity DOC Generator to help manufacturers create their EU Declaration of Conformity in a structured way.

ScopeRight Declaration of Conformity DOC Generator

The generator supports the creation of the document, but it does not replace the manufacturer’s responsibility to determine the applicable legislation, verify conformity and ensure that the information in the declaration is correct.

The Key Point

The EU Declaration of Conformity is not simply a certificate generated after testing.

It is the manufacturer’s formal statement:

“We have assessed our product against the applicable requirements and declare, under our responsibility, that it conforms.”

The DoC should therefore be the result of a completed conformity assessment, supported by the technical documentation and evidence behind it.

12. Affixing the CE Marking

The CE marking may be affixed only after the required conformity assessment procedure has been completed and the manufacturer can declare conformity with the applicable requirements.

The CE marking is therefore not the beginning, but the visible result of the completed conformity process.

When Can the CE Marking Be Affixed?

Before affixing the CE marking, the manufacturer must, as applicable:

• Identify the applicable EU legislation
• Assess the relevant requirements
• Complete the required conformity assessment procedure
• Prepare the technical documentation
• Draw up the EU Declaration of Conformity
• Involve a required Notified Body, where applicable

Only once the required steps have been completed may the CE marking be affixed.

The principle is:

CE marking is the result of conformity — not evidence that a single test was passed.

Where Must the CE Marking Be Affixed?

The CE marking should generally be visible, legible and permanent and affixed to the product.

Where this is not possible because of the nature or characteristics of the product, the applicable legislation may allow it to be placed, for example, on:

• The packaging
• A label
• Accompanying documentation

The exact requirements can vary depending on the product and applicable legislation.

The manufacturer should therefore not automatically assume that the CE marking must always appear directly on the product.

What Does the CE Marking Have to Look Like?

The CE marking must follow the prescribed graphic design.

Among other requirements:

• The proportions of the CE marking must be maintained.
• The individual elements must have the same vertical dimension.
• The height must generally be at least 5 mm.

If the CE marking is enlarged or reduced, its proportions must remain unchanged.

The CE marking therefore cannot simply be redesigned or modified to suit a company’s preferred typography or branding.

What If a Notified Body Was Involved?

If a Notified Body has been involved in the required conformity assessment procedure and the applicable legislation requires its identification number to be shown, the Notified Body identification number must appear alongside the CE marking.

For example:

CE 0123

The number identifies the relevant Notified Body.

It should not, however, be added simply because a laboratory or another organisation issued a test report.

What matters is whether the organisation actually acted as a Notified Body for the applicable conformity assessment procedure.

What If Several Pieces of EU Legislation Apply?

When a product falls under several pieces of EU legislation that require CE marking, one CE marking represents conformity with the applicable legislation.

The accompanying documentation may additionally need to identify the relevant legislation and demonstrate that the corresponding requirements have been addressed.

A product therefore does not need a separate CE marking for every applicable directive or regulation.

What matters is that all applicable requirements have been fulfilled and documented.

CE Marking and Product Variants

Particular attention is required when a manufacturer sells multiple product variants.

Differences in:

• Hardware
• Radio modules
• Antennas
• Power supplies
• Enclosures
• Software
• Firmware
• Accessories
• Operating modes

can affect the conformity assessment.

The CE marking itself does not necessarily have to be different for each variant. However, the underlying conformity assessment and technical documentation must cover the variants actually placed on the market.

CE Marking and Other Markings

A product may also be required to carry other legally required markings.

Which additional markings are required depends on the product and applicable legislation.

The CE marking should therefore not be treated as a replacement for other mandatory information.

Likewise, voluntary logos or certification marks must not be presented in a way that suggests they are part of the CE marking or represent an official EU approval.

The Key Point

The CE marking is the final visible step in a much broader process:

Applicable legislation → Requirements → Standards → Risk assessment → Conformity assessment → Testing → Technical documentation → EU Declaration of Conformity → CE marking

The CE marking itself does not show how conformity was demonstrated.

It indicates that, after completing the required process, the manufacturer declares that the product complies with the requirements applicable to its CE marking.

13. Manufacturer, Importer and Distributor Responsibilities

The responsibility for CE conformity generally lies with the manufacturer. Depending on the supply chain and the origin of the product, however, importers, distributors and authorised representatives may also have specific legal obligations.

What matters is not only who physically manufactures the product. Companies that place a product on the market under their own name or trademark, or that substantially modify a product, may also be treated as manufacturers.

Who Is the Manufacturer?

The manufacturer is generally the natural or legal person who manufactures a product, or has it designed or manufactured, and markets it under its own name or trademark.

This means:

The manufacturer does not necessarily have to be the factory that physically produces the product.

For example, a company may have a product manufactured by an OEM and then sell it under its own brand. In that case, the company generally assumes the manufacturer’s responsibilities.

Key manufacturer responsibilities include:

• Identifying the applicable EU legislation
• Carrying out the conformity assessment
• Preparing the technical documentation
• Drawing up the EU Declaration of Conformity
• Affixing the CE marking
• Ensuring product identification and traceability
• Providing required instructions and safety information
• Addressing conformity appropriately after the product has been placed on the market

Products Sold Under Your Own Brand

A common misconception is:

“The actual manufacturer has already made the product CE compliant, so I am not responsible.”

That is not necessarily correct.

If a company places a product on the market under its own name or trademark, it may itself be considered the manufacturer and assume the corresponding manufacturer responsibilities.

Existing test reports or CE documentation from the OEM may provide useful technical evidence. However, the regulatory responsibility associated with placing the product on the market under your own brand still needs to be assessed.

Importers of Products from Outside the EU

An importer is an EU-based economic operator that places a product from a third country on the EU market.

Importers have their own obligations.

Among other things, they must carry out appropriate checks to ensure that:

• The product meets the applicable conformity requirements
• The CE marking is present where required
• The technical documentation has been prepared
• The EU Declaration of Conformity is available
• Required markings and information are present
• The manufacturer’s and, where applicable, importer’s details are provided

An importer does not automatically have to perform the complete conformity assessment itself.

However, it cannot simply rely on a supplier stating:

“The product is CE compliant.”

The legally required checks and controls still need to be carried out.

Authorised Representative

Under certain conditions, a manufacturer can appoint an Authorised Representative in the EU.

The Authorised Representative acts within the scope of a mandate provided by the manufacturer.

An important point is:

Appointing an Authorised Representative does not automatically transfer the manufacturer’s entire responsibility.

The manufacturer generally remains responsible for the conformity of its product.

The actual responsibilities of the Authorised Representative depend on the scope of the mandate and the applicable legislation.

Distributors

A distributor purchases or sells a product without generally acting as the manufacturer or importer.

Distributors nevertheless have their own obligations.

They must, among other things, exercise due care and check that the product, where applicable:

• Is correctly marked
• Is accompanied by the required information
• Carries the CE marking where required
• Includes the required manufacturer and importer information

Distributors must also take appropriate action if they have reason to believe that a product is not compliant.

When Does an Importer or Distributor Become the Manufacturer?

This is particularly important.

If an economic operator places a product on the market under its own name or trademark, it may be considered the manufacturer.

Similarly, a substantial modification of a product already on the market can result in the party making the modification assuming manufacturer responsibilities if the modification affects the product’s conformity with the applicable requirements.

This can potentially be relevant to changes involving:

• Hardware
• Software
• Radio functionality
• Safety functions
• Power supply
• Enclosure
• Critical components

Whether a particular modification has this effect must be assessed on a case-by-case basis.

Why Supply Chain Roles Matter

An internationally marketed product may involve several different parties:

Manufacturer → Importer → Distributor → End Customer

Each party may have different legal obligations.

The situation becomes particularly important when the roles are not clearly defined.

For example, a company may believe:

“We are only the distributor.”

But if it sells the product under its own brand, the regulatory assessment may be very different.

The Key Point

CE conformity is not only a question of technical testing.

It is also important to establish:

Who is legally the manufacturer? Who imports the product? Who distributes it? Who is responsible for what?

And particularly:

A company that places a product on the market under its own name or trademark may thereby become the manufacturer.

The roles within the supply chain should therefore be clearly determined and documented before the product is placed on the market.

14. Changes After CE Conformity Assessment

CE conformity is not a one-time assessment that automatically remains valid for every future version of a product.

When an already assessed product is modified, the manufacturer should determine whether the change affects the existing conformity assessment.

This does not mean that every minor change automatically requires a complete new test campaign. The key question is whether the change affects the applicable requirements, risks or underlying conformity evidence.

What Happens When the Product Changes?

After a product change, the manufacturer should first determine:

• What has changed?
• Which functions are affected?
• Which requirements could be affected?
• Does the risk profile change?
• Are the previously applied standards still applicable?
• Are existing test reports still representative?
• Does the technical documentation need to be updated?
• Does the EU Declaration of Conformity need to be updated?

The right question is therefore not:

“Is the change small or significant?”

but:

“Does the change affect the conformity of the product?”

Hardware Changes

Hardware changes can have very different consequences.

Examples include:

• Replacing an IC
• Changing the power supply
• Changing the PCB layout
• Introducing a new enclosure
• Changing cables
• Changing connectors
• Changing a safety-critical component

A change can potentially affect:

• Electrical safety
• EMC
• Temperature
• Mechanical safety
• Radio performance
• RF exposure

The impact of the change should therefore be assessed systematically before deciding whether additional testing is necessary.

Software and Firmware Changes

Software or firmware changes can also be relevant to conformity.

This is particularly important when a change affects functions that are relevant to compliance.

Examples may include:

• Changes to operating modes
• Changes to radio parameters
• Changes to power levels
• Changes to safety functions
• Changes to protective mechanisms
• New user functions

Not every software change automatically requires new testing.

The important question is what the change actually changes in the product and its conformity.

Changes to Radio Modules and Antennas

Particular care is required for radio products.

Changes to:

• Radio modules
• Antennas
• Antenna gain
• Antenna position
• RF power
• Frequency ranges
• Firmware
• Radio parameters
• Simultaneous transmitters

can affect the existing assessment.

A radio module that has already been tested or certified therefore does not automatically mean that every subsequent integration or modification can be accepted without further assessment.

The actual product configuration must be considered.

New Components

Even replacing a single component should not be considered in isolation.

For example, a new power supply can affect:

• Electrical safety
• EMC
• Temperature
• Creepage and clearance
• Fire risks

A new radio module, on the other hand, may affect:

• Radio parameters
• EMC
• RF exposure
• Antenna configuration

The key question should therefore be:

Which conformity evidence depended on the original component, and does that evidence remain valid after the change?

New Accessories

New accessories can also affect an existing conformity assessment.

This becomes particularly relevant when the accessory:

• Is electrically connected to the main product
• Changes the power supply
• Influences radio functionality
• Performs a safety-related function
• Expands the intended use
• Creates a new configuration when used with the main product

In these cases, the manufacturer should determine whether the existing technical documentation and test evidence still cover the new configuration.

An accessory should therefore not automatically be considered regulatorily irrelevant simply because the main product is already CE compliant.

Does the Product Need to Be Retested?

Not every change automatically requires complete retesting.

Depending on the change, it may be sufficient to perform:

• A technical assessment
• A documentation review
• A risk assessment
• Limited testing
• Targeted repeat testing
• Or, where the change has no relevant impact, a documented justification explaining why no additional testing is required

The decision should be documented in a traceable manner.

It is particularly important to document the change itself and its impact on conformity.

Changes After Placing the Product on the Market

Change assessment is not only relevant when developing a completely new product.

Changes can also occur throughout the product lifecycle, for example through:

• Supplier changes
• Component obsolescence
• New firmware
• New software
• New power supplies
• New accessories
• Production changes
• New product variants

A functioning change-control process helps ensure that such changes do not unintentionally affect existing conformity.

What Should Be Documented for a Change?

A useful change-impact assessment should record, among other things:

1. What was changed?
2. Why was it changed?
3. Which requirements could be affected?
4. Which risks are affected?
5. Which existing evidence remains valid?
6. Are additional assessments or tests required?
7. Which documents need to be updated?
8. Does the EU Declaration of Conformity need to be updated?

This creates a traceable connection between the change and the decision regarding continued conformity.

The Key Point

An existing CE assessment is not a free pass for all future product changes.

For every relevant change, the impact on conformity should first be assessed:

Change → Impact Assessment → Affected Requirements → Risk → Existing Evidence → Additional Assessment/Testing → Documentation

Only then should the manufacturer determine whether the existing conformity assessment remains sufficient or needs to be updated.

15. Post-Market Surveillance and Corrective Actions

CE conformity does not end when the product is placed on the market.

Manufacturers have ongoing responsibilities to monitor their products after placing them on the market, identify potential compliance or safety issues and take appropriate action when necessary.

Post-market activities are particularly important because problems may only become visible once a product is used by a larger number of customers or under real-world conditions.

What Is Post-Market Surveillance?

Post-market surveillance means collecting and evaluating information about a product after it has been placed on the market.

Depending on the product and applicable legislation, relevant information can come from:

• Customer complaints
• Service and repair information
• Returns
• Warranty claims
• Incident reports
• Field failures
• Distributor feedback
• Installer feedback
• Production data
• Regulatory authorities
• Market surveillance activities
• New technical or regulatory information

The objective is to determine whether the product continues to meet the applicable requirements and whether previously unknown risks have emerged.

Why Is Post-Market Surveillance Important?

A product can pass all required tests before market launch and still develop problems later.

For example:

• A component may fail in the field.
• A supplier may change a component without informing the manufacturer.
• A firmware update may introduce a new operating condition.
• A previously unknown use case may emerge.
• Customers may use the product differently than expected.
• A new safety or regulatory issue may become known.

Post-market surveillance provides a mechanism for identifying these issues.

The manufacturer should therefore not treat CE compliance as:

“The product passed testing, so the project is finished.”

Instead, conformity should be considered throughout the product lifecycle.

What Should Be Monitored?

The exact requirements depend on the applicable legislation and product category.

Depending on the product, manufacturers may monitor:

• Safety incidents
• Product failures
• Customer complaints
• EMC-related problems
• Radio performance issues
• Overheating
• Battery incidents
• Software or firmware problems
• Unexpected operating conditions
• Recurring component failures
• Changes in applicable standards
• Changes in legislation

Not every customer complaint is automatically a regulatory issue.

The important point is to have a structured process for determining whether an issue could affect product conformity or safety.

What Happens When a Problem Is Identified?

When a potential compliance or safety issue is identified, the manufacturer should assess its significance.

Possible actions can include:

• Technical investigation
• Additional testing
• Risk reassessment
• Design modification
• Software or firmware update
• Updated instructions
• Customer notification
• Repair
• Replacement
• Withdrawal from the market
• Recall

The appropriate action depends on the nature and severity of the problem.

Corrective vs. Preventive Actions

Corrective action addresses an identified problem.

For example:

A component is overheating in certain operating conditions → investigate the cause → modify the design → verify the modification.

Preventive action aims to avoid a potential problem before it occurs.

For example:

A supplier announces a component change → assess the change before introducing it into production.

Both approaches can be important components of an effective compliance process.

What About Serious Risks?

If a manufacturer discovers that a product presents a serious risk or does not comply with applicable requirements, additional obligations may apply.

Depending on the circumstances, the manufacturer may need to:

• Take immediate corrective action
• Stop placing the product on the market
• Withdraw products
• Recall products already sold
• Inform relevant authorities
• Provide information to customers

The exact obligations depend on the applicable EU legislation and the nature of the problem.

The manufacturer should therefore have a defined process for escalating potentially serious compliance or safety issues.

Connecting Post-Market Surveillance With Change Control

Post-market surveillance should not operate independently from the product’s change-control process.

For example:

Field issue

↓

Technical investigation

↓

Risk assessment

↓

Design or software change

↓

Change impact assessment

↓

Additional testing, where required

↓

Update technical documentation

↓

Corrective action

This creates a continuous feedback loop between the product in the field and the compliance documentation.

Regulatory and Standard Updates

Post-market compliance is also affected by changes in the regulatory environment.

Manufacturers should monitor relevant developments such as:

• New or revised EU legislation
• New harmonised standards
• Changes in OJEU publications
• Withdrawal of standards
• Transition periods
• New regulatory guidance
• Changes affecting the product’s technology

A product that was compliant when originally placed on the market may therefore need to be reassessed when significant regulatory or technical changes occur, depending on the applicable legislation and circumstances.

The Key Point

CE compliance does not end when the CE mark is applied.

A robust compliance process continues throughout the product lifecycle:

Place on market → Monitor → Identify issues → Assess impact → Correct → Verify → Update documentation

The objective is not only to demonstrate that the product was compliant when it entered the market, but to ensure that the manufacturer can respond appropriately when new risks, failures, changes or regulatory developments arise.

16. Market Surveillance and Regulatory Inspections

Even if a manufacturer has assessed and documented CE conformity, this does not mean that the product is exempt from regulatory checks.

The market surveillance authorities of EU Member States can inspect products and verify whether they comply with the applicable requirements.

What Is Market Surveillance?

Market surveillance refers to the regulatory control of products made available on the EU market.

Authorities may, for example, check:

• Whether the CE marking has been correctly affixed
• Whether the required information is available
• Whether an EU Declaration of Conformity exists
• Whether the technical documentation is available
• Whether the product meets the applicable requirements
• Whether the stated standards and technical evidence are plausible
• Whether the product presents a safety or other relevant risk

Market surveillance can be document-based, but may also involve an actual technical investigation or testing of the product.

What Can Authorities Request From a Manufacturer?

Depending on the applicable legislation and circumstances, authorities may request documents such as:

• EU Declaration of Conformity
• Technical documentation
• Test reports
• Risk assessment
• Applied standards
• Technical drawings
• Component information
• Product markings
• Instructions for use
• Other evidence of conformity

The manufacturer must be able to provide the required documentation within the applicable timeframe.

This is another reason why technical documentation should not be assembled only after receiving a request from an authority.

What Happens During an Inspection?

A market surveillance investigation may begin with a request for documentation.

The authority may then identify several possible outcomes.

No Issues Identified

If the documentation and product meet the applicable requirements, the investigation may be closed without further action.

Documentation Deficiency

The product itself may be technically compliant, but the manufacturer may have incomplete or incorrect documentation.

Corrective action may then be required.

Technical Non-Conformity

If the product itself does not meet an applicable requirement, further measures may be necessary.

Safety Risk

Where a serious risk is identified, authorities may take significantly more extensive measures.

What Measures Can Authorities Take?

Depending on the circumstances and applicable legislation, authorities may take measures such as:

• Requesting corrective action
• Restricting or stopping sales
• Restricting the product’s availability on the market
• Requiring withdrawal from the market
• Requiring a recall of products already sold
• Warning consumers or other users
• Taking other regulatory measures

The appropriate action depends particularly on the nature of the non-conformity and the associated risk.

A Test Report Does Not Automatically Protect Against Regulatory Action

A common misconception is:

“We have a laboratory test report, so the authority cannot challenge the product.”

That is not necessarily true.

A test report is technical evidence for the characteristics and conditions that were actually assessed.

A market surveillance authority may nevertheless determine, for example, that:

• Different EU legislation applies
• A relevant requirement was not assessed
• The tested configuration does not correspond to the production product
• A different component is being used
• The technical documentation is incomplete
• The risk assessment is inadequate
• A product change affects the original evidence

The entire conformity assessment rationale therefore needs to be traceable.

What If the Product Has Been Changed?

A regulatory inspection can become particularly challenging when the product differs from the configuration that was originally tested.

For example:

Tested product

→ Different power supply

→ Different radio module

→ New firmware

→ New antenna

→ Production product

If the existing test reports only cover the original configuration, the manufacturer needs to determine whether the evidence remains applicable to the product actually being placed on the market.

How Can a Manufacturer Prepare?

Good preparation is not about collecting as many documents as possible.

What matters much more is having a structured and traceable compliance framework.

A manufacturer should be able to answer questions such as:

What product was assessed?

Which legislation applies?

Which requirements were considered?

Which standards were applied?

Which risks were assessed?

Which tests were performed?

Which evidence addresses which requirements?

Which product variants are covered?

What changes have been made since the original assessment?

If these questions can be answered quickly and clearly, the manufacturer is much better prepared for a market surveillance investigation.

The Key Point

CE marking does not mean that a product has been pre-approved by a government authority.

The responsibility for conformity generally remains with the economic operator carrying the applicable obligations. Market surveillance authorities can subsequently verify whether those requirements are actually being met.

Manufacturers should therefore structure their compliance documentation so that it can withstand a potential regulatory review:

Declare conformity → Document the evidence → Keep the documentation available → Control changes → Respond to market surveillance.

17. CE Compliance Checklist – From Product Definition to Market Access

The CE conformity process involves many individual steps. A structured checklist helps ensure that important requirements are not overlooked and that the evidence supporting conformity remains traceable.

The following checklist can be used as a practical overview of the complete process.

1. Define the Product

Before starting the conformity assessment, clearly define the product being assessed.

Consider:

• Product name and model
• Product variants
• Intended use
• Intended users
• Operating environment
• Main functions
• Electrical characteristics
• Radio technologies
• Accessories
• Software and firmware
• Product configuration

The compliance assessment should always relate to the actual product that will be placed on the market.

2. Identify the Applicable EU Legislation

Determine which EU legislation applies to the product.

Depending on the product, this may include:

• Radio Equipment Directive (RED)
• EMC Directive
• Low Voltage Directive (LVD)
• RoHS
• Machinery legislation
• Medical Device Regulation
• Other product-specific legislation

Do not assume that the product falls under only one legal framework.

3. Identify the Applicable Requirements

For each applicable piece of legislation, determine which requirements are relevant to the product.

Consider:

• Safety
• EMC
• Radio
• RF exposure
• Environmental requirements
• Substances
• Software-related requirements
• Product-specific requirements

The objective is to establish a complete picture of what the product must demonstrate.

4. Determine the Conformity Assessment Procedure

Establish which conformity assessment procedure applies.

Determine:

• Whether internal production control is sufficient
• Whether a Notified Body must be involved
• Which specific conformity assessment modules apply
• What documentation and evidence are required

This step should be completed before finalising the test strategy.

5. Select the Appropriate Standards

Identify the standards that can be used to demonstrate conformity.

Check:

• Product applicability
• Relevant edition
• Scope
• Applicable requirements
• Harmonisation status
• OJEU publication status
• Transition periods
• Any restrictions or limitations

Do not select standards solely because they are commonly used for similar products.

6. Perform the Risk Assessment

Identify the hazards associated with the product and evaluate the relevant risks.

Consider:

• Normal operation
• Reasonably foreseeable misuse
• Failure conditions
• Environmental conditions
• Product variants
• Accessories
• Software and firmware

Document the measures used to reduce the identified risks and how their effectiveness is verified.

7. Define the Test and Assessment Plan

Determine which requirements need to be demonstrated through:

• Laboratory testing
• Pre-compliance testing
• Calculations
• Technical assessment
• Risk assessment
• Component evidence
• Material documentation
• Other technical evidence

The objective should not simply be to create the largest possible test program.

The objective is to create a complete and justified evidence strategy.

8. Perform Pre-Compliance Testing Where Appropriate

Where technically useful, perform pre-compliance testing before formal laboratory testing.

This can help identify issues early and reduce the risk of:

• Test failures
• Retesting
• Development delays
• Late design changes
• Additional laboratory costs

Pre-compliance testing does not automatically replace formal conformity testing where such testing is required.

9. Complete Formal Testing and Technical Evaluation

Perform the required testing and other technical assessments.

Collect and review:

• Safety test reports
• EMC test reports
• Radio test reports
• RF exposure assessments
• Calculations
• Technical assessments
• Component evidence

Verify that the tested configuration corresponds to the actual product.

10. Prepare the Technical Documentation

Build the technical documentation around the complete conformity assessment.

Include, as applicable:

• Product description
• Technical drawings
• Schematics
• Bill of materials
• Risk assessment
• Applied standards
• Test reports
• Calculations
• Technical assessments
• Software information
• Product variants
• Other required evidence

The documentation should provide a traceable chain from the product to the final conformity conclusion.

11. Review the Complete Compliance Assessment

Before issuing the Declaration of Conformity, perform a final review.

Ask:

Have all applicable pieces of EU legislation been identified?

Have all relevant requirements been addressed?

Are the selected standards appropriate?

Are the test reports representative of the final product?

Are product variants covered?

Are the risks adequately addressed?

Is the technical documentation complete?

Is a Notified Body required?

This final review can identify gaps before the product reaches the market.

12. Issue the EU Declaration of Conformity

Once the conformity assessment is complete, prepare and sign the EU Declaration of Conformity.

Verify that it correctly identifies:

• The manufacturer
• The product
• Applicable legislation
• Relevant standards
• Notified Body information, where applicable
• Date
• Authorised signatory

The DoC must correspond to the actual product and its completed conformity assessment.

13. Affix the CE Marking

Once all required steps have been completed, affix the CE marking in accordance with the applicable requirements.

Check:

• Correct CE symbol
• Correct dimensions and proportions
• Visibility
• Legibility
• Permanence
• Notified Body number, where required
• Placement on the product, packaging or documentation where permitted

14. Prepare for Market Placement

Before placing the product on the EU market, ensure that the required information is available.

Depending on the product, this can include:

• Instructions
• Safety information
• Warnings
• Manufacturer information
• Importer information
• Product identification
• CE marking
• EU Declaration of Conformity
• Other mandatory information

15. Maintain Compliance After Market Launch

CE compliance continues after the product has been placed on the market.

Maintain processes for:

• Post-market surveillance
• Customer complaints
• Incident handling
• Corrective actions
• Regulatory monitoring
• Standards monitoring
• Supplier changes
• Component changes
• Software and firmware updates
• Product modifications

Changes should be assessed for their potential impact on conformity.

16. Control Product Changes

Whenever the product changes, perform a Change Impact Assessment.

Consider:

What changed?

↓

Which requirements could be affected?

↓

Which risks could change?

↓

Which existing evidence remains valid?

↓

Is additional testing or assessment required?

↓

Which documentation needs to be updated?

This prevents the common situation where the compliance documentation describes a product that no longer corresponds to the actual production version.

Final CE Compliance Check

Before releasing a product, the manufacturer should be able to demonstrate a complete chain:

Product

↓

Applicable EU Legislation

↓

Requirements

↓

Conformity Assessment Procedure

↓

Standards

↓

Risk Assessment

↓

Testing & Technical Evaluation

↓

Technical Documentation

↓

EU Declaration of Conformity

↓

CE Marking

↓

Market Surveillance & Change Control

The Key Point

A successful CE process is not simply:

“Test the product → get a report → put CE on it.”

It is a structured process in which every relevant requirement is identified, assessed and supported by appropriate evidence.

The strongest CE compliance approach is therefore one where the manufacturer can trace every important regulatory requirement back to the product and forward to the evidence demonstrating conformity.

18. ScopeRight as Support Throughout the CE Compliance Process

The CE compliance process involves numerous individual tasks — from the initial regulatory assessment and selection of applicable standards through technical documentation, risk assessment and the Declaration of Conformity.

This is where ScopeRight can help.

ScopeRight does not replace the manufacturer’s responsibility. Instead, the platform is designed to make the compliance process more structured, traceable and efficient.

From a Regulatory Question to Concrete Evidence

A typical compliance project can quickly become complex:

Product

→ Which legislation applies?

→ Which requirements are relevant?

→ Which standards need to be considered?

→ Which tests are required?

→ Which risks need to be assessed?

→ Which documentation is required?

→ Which declaration needs to be prepared?

ScopeRight supports several of these steps through specialised Wizards and its Standards Database.

ScopeRight Wizards

ScopeRight Wizards – German

ScopeRight Wizards

The ScopeRight Wizards are designed to address specific compliance tasks in a structured way.

Depending on the task, they can support areas such as:

• Regulatory Scoping
• EMC Scoping
• Radio Scoping
• Safety Scoping
• MPE Calculations
• Risk Assessment
• Declaration of Conformity
• Other compliance-related tasks

The Wizards are designed to turn product-specific information into structured compliance results.

ScopeRight Standards Database

Selecting and evaluating standards is a central part of the CE process.

The ScopeRight Standards Database provides structured information on relevant standards and helps manufacturers maintain an overview of standards and their regulatory relevance.

ScopeRight Standards Database

ScopeRight Standards Database – German

Especially for products involving multiple regulatory areas, a structured approach to standards can help make the compliance assessment more efficient.

Risk Assessment Wizard

Risk assessment is an important part of many compliance projects.

The ScopeRight Risk Assessment Wizard helps manufacturers structure and document their product-related risk assessment.

ScopeRight Risk Assessment Wizard

ScopeRight Risk Assessment Wizard – German

The Wizard does not replace the manufacturer’s technical responsibility. It supports the process and helps structure the assessment systematically.

Declaration of Conformity DOC Generator

At the end of the conformity process, manufacturers often need to prepare the EU Declaration of Conformity.

ScopeRight provides a Declaration of Conformity DOC Generator that helps manufacturers create their Declaration of Conformity in a structured format.

ScopeRight Declaration of Conformity DOC Generator

ScopeRight Declaration of Conformity DOC Generator – German

This provides direct support for another step in the CE compliance workflow.

A Structured Compliance Workflow

The individual ScopeRight functions can be viewed as part of a broader process:

Product

↓

Regulatory Scoping

↓

Applicable Requirements

↓

Standards

↓

Risk Assessment

↓

Testing & Technical Evaluation

↓

Technical Documentation

↓

Declaration of Conformity

↓

CE Marking

ScopeRight can support individual steps within this process without taking over the manufacturer’s legal responsibility.

Not Just for the Final CE Marking

Compliance should not begin only when a product is already fully developed.

An early regulatory assessment can help identify:

• Which requirements are relevant
• Which standards need to be considered
• Which tests are likely to be required
• Which risks need to be addressed
• Which evidence will be needed later

This allows compliance considerations to be incorporated during product development, rather than being addressed only at the end.

The ScopeRight Approach

ScopeRight follows a straightforward approach:

Understand the Scope. Control the Compliance.

Rather than treating compliance as something that happens at the end of product development, the goal is to structure compliance from an early stage.

The platform therefore brings together regulatory intelligence, standards and practical compliance tools within a structured workflow.

Explore ScopeRight

The Key Point

ScopeRight does not replace the manufacturer, a test laboratory or, where required, a Notified Body.

Instead, ScopeRight is designed to make the process between those activities more structured, transparent and efficient:

Regulatory Assessment → Standards → Risk → Testing → Documentation → Declaration

The goal is to turn a collection of individual compliance tasks into a structured and traceable process.

9. Common Mistakes in the CE Compliance Process

The CE process can appear straightforward at first, but in practice it involves many interconnected steps. Many compliance problems do not arise because a manufacturer does nothing, but because individual steps are performed in the wrong order or are not properly connected.

The following mistakes are particularly common.

1. Starting With Testing

A common approach is:

“We need CE — which tests do we need?”

The problem is that testing should not be the starting point of the compliance assessment.

The process should first establish:

Product → Legislation → Requirements → Conformity Assessment → Standards → Testing

Otherwise, a manufacturer may perform extensive testing while still failing to address relevant regulatory requirements.

2. Treating One Standard as the Complete Compliance Solution

A standard may address important requirements, but it is not automatically the entire regulatory framework.

Manufacturers should therefore not assume:

“We tested to EN XXXX, so the product is CE compliant.”

Instead, they should determine:

• Which requirements does the standard cover?
• Which requirements remain open?
• Is the standard appropriate for the specific product?
• Is it harmonised?
• Is the relevant version published in the OJEU?
• Are there limitations or specific conditions?

3. Looking at Only One Test Report

Another common mistake is equating a test report with conformity.

A test report essentially answers:

“How did this product perform under these specific tests and conditions?”

It does not automatically answer:

“Does this product meet all applicable legal requirements?”

Test reports therefore need to be evaluated as part of the overall compliance assessment.

4. Treating a Certified Radio Module as a Complete Solution

This is particularly common with radio products.

An already tested or certified radio module can significantly simplify development and compliance work.

However, it does not automatically mean that the complete host product is compliant.

Integration can affect factors such as:

• Antenna
• Antenna position
• PCB
• Power supply
• Enclosure
• EMC
• RF exposure
• Simultaneous radio transmissions
• Firmware

Module evidence therefore needs to be assessed for its applicability to the actual end product.

5. Creating the Risk Assessment Only at the End

A risk assessment should not simply be created to tick a box in the technical documentation.

An early risk assessment can influence important product development decisions.

It may show, for example, that:

• A different component is required
• An additional protective measure is necessary
• A particular function should be modified
• Additional testing is needed

Creating the risk assessment only at the end of the project can mean that problems are discovered when changes are already expensive.

6. Creating the Technical Documentation Just Before Market Launch

A folder containing test reports, drawings and declarations assembled shortly before market launch is not automatically good technical documentation.

The documentation should make the actual decision-making process traceable:

What was assessed?

↓

Which requirements apply?

↓

How were they assessed?

↓

What evidence exists?

↓

Why is that evidence sufficient?

If this information has to be reconstructed afterwards, gaps and inconsistencies can easily arise.

7. Underestimating Product Changes

Products rarely remain completely unchanged throughout their lifecycle.

Components become obsolete, suppliers change, firmware is updated and components are replaced.

A common assumption is:

“It is only a small component, so it cannot affect CE.”

That should not simply be assumed.

Instead, the change should be assessed:

Change → Affected requirements → Risk → Existing evidence → Additional assessment

This makes it possible to determine whether the existing conformity assessment remains sufficient.

8. Treating a “CE Certificate” as the Goal

Many manufacturers search for a “CE Certificate”, even though their product may not require such a certificate.

CE conformity does not generally work as:

Product → Certificate → CE

Depending on the product and applicable legislation, the process may instead be:

Requirements → Conformity Assessment → Technical Evidence → EU Declaration of Conformity → CE Marking

Whether a Notified Body must be involved depends on the applicable conformity assessment procedure.

9. Treating the EU Declaration of Conformity as a Formality

The DoC is sometimes created at the very end simply as a document that is “needed for CE.”

In reality, it is the manufacturer’s formal declaration that the product complies with the applicable requirements.

If, for example, the standards, product variants or legislation stated in the DoC do not correspond to the actual conformity assessment, the DoC itself can become problematic.

It should therefore accurately reflect the completed assessment.

10. Testing a Different Product From the One Actually Sold

A test report can be technically correct and still have limited value if the tested configuration does not correspond to the product eventually placed on the market.

Differences may include:

• Power supply
• Antenna
• Enclosure
• Cables
• Radio module
• Firmware
• Components
• Accessories
• Operating modes

The question should therefore always be:

“Is the tested product actually representative of the product being placed on the market?”

The Common Problem Behind Many CE Issues

Many of these mistakes have the same underlying cause:

Compliance is treated as a collection of individual documents and tests.

A robust compliance assessment should instead work as a connected chain of reasoning:

Product → Legislation → Requirements → Risks → Standards → Assessment → Testing → Evidence → Declaration of Conformity

When this chain is traceable, many typical compliance problems can be identified early.

The Key Point

The most common CE problems do not necessarily arise because a manufacturer tested too little.

Often, the problem is that:

• The wrong requirements were assessed
• Evidence does not match the actual product configuration
• Standards were selected incorrectly
• Changes were not assessed
• Or the technical documentation does not clearly explain the conformity decision

The key question should therefore not be:

“Do we have all the required documents?”

but:

“Can we clearly demonstrate why this specific product is compliant?”

20. CE Compliance in Practice – How to Build a Robust Process

A strong CE compliance process is not about completing a fixed list of documents at the end of a project. It is about building a traceable compliance chain from the product definition through to market placement and ongoing product changes.

The European Commission describes the manufacturer’s core CE responsibilities around identifying applicable legislation and standards, assessing product-specific requirements, determining the appropriate conformity assessment procedure, preparing technical documentation, issuing the EU Declaration of Conformity and affixing the CE marking.

Start With the Product — Not the Test

The most effective approach is to begin with the actual product.

Before asking which tests are required, establish:

• What the product does
• How it is powered
• Whether it contains radio functionality
• Where it will be used
• Who will use it
• Which accessories are involved
• Which software and firmware are part of the product
• Which variants will be placed on the market

Only then can the regulatory scope be established properly.

Build the Compliance Scope Early

Once the product is defined, determine the applicable regulatory framework.

A single product can be subject to multiple EU directives or regulations, so the assessment should not stop after identifying the first applicable piece of legislation.

A useful structure is:

Product

↓

Applicable EU Legislation

↓

Essential / Applicable Requirements

↓

Conformity Assessment Procedure

↓

Standards and Technical Specifications

This provides the foundation for everything that follows.

Turn Requirements Into Evidence

Once the requirements are known, determine how each one will be demonstrated.

Evidence may include:

• Laboratory testing
• Technical assessment
• Risk assessment
• Calculations
• Component documentation
• Software information
• Existing test evidence
• Design documentation
• Other technical evidence

The important question is not simply:

“Which tests do we need?”

It is:

“What evidence do we need to demonstrate each applicable requirement?”

This distinction can prevent unnecessary testing while also reducing the risk of leaving requirements unaddressed.

Keep the Product and Evidence Connected

Every important piece of evidence should be traceable to the product configuration it supports.

For example:

Product Variant A

→ Hardware revision

→ Radio module

→ Antenna

→ Firmware version

→ Applicable standards

→ Test reports

→ Risk assessment

→ Technical documentation

This becomes particularly important when products have multiple variants or are changed during their lifecycle.

Make Changes Part of the Compliance Process

A robust CE process does not end when the first product version is released.

When something changes, the manufacturer should have a defined process for determining whether the change affects conformity.

For example:

Component change

↓

Change Impact Assessment

↓

Affected requirements

↓

Existing evidence

↓

Additional assessment/testing if required

↓

Documentation update

This makes change control part of compliance rather than treating it as a separate engineering activity.

Make the Technical Documentation Tell the Story

The technical documentation should allow someone who was not involved in the original project to understand why the manufacturer considers the product compliant.

A well-structured technical file should connect:

Product → Requirements → Assessment → Evidence → Conclusion

The European Commission states that the technical documentation must enable conformity with the applicable legislative requirements to be assessed.

This is much more valuable than simply storing documents in a folder without a clear relationship between them.

Keep the Declaration of Conformity Consistent

The EU Declaration of Conformity should reflect the actual completed assessment.

The information in the DoC should therefore be consistent with:

• The actual product
• Applicable legislation
• Applied standards
• Product variants
• Notified Body involvement, where applicable
• The technical documentation

The DoC is the manufacturer’s formal declaration of responsibility for conformity.

Think Beyond the CE Mark

The CE marking is the visible result of the conformity process, but it is not the process itself.

The European Commission explicitly notes that CE marking does not mean that a product has been approved as safe by the EU or another authority.

The real compliance work happens behind the CE mark:

Scope

→ Requirements

→ Assessment

→ Evidence

→ Documentation

→ Declaration

→ CE Marking

→ Market Surveillance

→ Change Control

A Practical Compliance Model

For manufacturers, the entire process can be reduced to five fundamental questions:

1. What are we putting on the market?

Define the actual product and its variants.

2. What rules apply?

Identify the applicable legislation and requirements.

3. How will we demonstrate conformity?

Determine the appropriate standards, assessments, tests and other evidence.

4. Can we prove our conclusion?

Build technical documentation that connects the requirements with the evidence.

5. What happens when something changes?

Maintain the assessment throughout the product lifecycle.

The Key Point

A robust CE process is not about having more documents, more tests or more certificates.

It is about having the right assessment, the right evidence and a clear connection between them.

The strongest compliance process is one where the manufacturer can move logically from:

“This is our product.”

to:

“These are the requirements that apply.”

to:

“This is how we assessed them.”

to:

“This is the evidence.”

to:

“This is why we can declare conformity.”

That is what turns CE compliance from a collection of individual tasks into a structured and defensible process.

Conclusion: CE Compliance Is a Process, Not a Mark

CE marking is often perceived as the final step of bringing a product to the European market. In reality, the CE mark is only the visible result of a much broader process.

A robust CE compliance process starts long before testing and continues long after the product has been placed on the market.

The essential principle is simple:

Understand what applies. Assess what matters. Demonstrate conformity. Document the evidence. Control changes.

The manufacturer must first understand the actual product and its intended use, identify all applicable EU legislation and requirements, and determine the appropriate conformity assessment procedure.

Only then can the relevant standards, tests, technical assessments and other evidence be selected.

The result should be a clear and traceable chain:

Product → Legislation → Requirements → Assessment → Evidence → Documentation → Declaration → CE Marking

But compliance does not end there.

Products change. Components become obsolete. Software and firmware are updated. Suppliers change. New standards and regulatory requirements emerge. Problems can also become visible only after a product is already in the field.

A mature compliance process therefore continues throughout the entire product lifecycle.

The goal is not more paperwork

Effective CE compliance is not about collecting as many test reports, certificates or documents as possible.

The real objective is to be able to answer a much more important question:

Why is this specific product compliant?

And to answer that question with evidence.

Every important requirement should be connected to an appropriate assessment or technical justification. The resulting evidence should correspond to the actual product configuration and be documented in a way that remains understandable and traceable.

That is what makes a CE compliance process defensible, maintainable and repeatable.

From Compliance at the End to Compliance by Design

The strongest approach is to integrate compliance into product development from the beginning rather than treating it as a final gate before market launch.

Early regulatory scoping can prevent inappropriate design decisions.
Early risk assessment can identify safety issues before they become expensive to fix.
Early standards selection can define the right testing strategy.
Structured technical documentation can prevent gaps later.
Change impact assessment can protect the conformity of subsequent product versions.

In other words:

CE compliance should not be something you do to a finished product. It should be something you manage throughout the development and lifecycle of the product.

And that is ultimately what makes the difference between simply putting a CE mark on a product and having a compliance process that you can genuinely stand behind.