CE Marking Explained: Requirements, Certification and Process

CE marking is a conformity marking used on products that meet applicable European Union (EU) legislation covering safety, health, environmental protection, and other regulated requirements. It indicates that the manufacturer has assessed the product’s conformity and assumes responsibility for meeting the relevant legal obligations.

CE marking is mandatory for product categories covered by EU legislation that specifically requires the marking. These include many electrical and electronic products, toys, machinery, personal protective equipment, medical devices, and certain construction products.

Before applying the CE mark, the manufacturer must identify applicable legislation, complete the required conformity assessment, prepare technical documentation, and issue the appropriate declaration of conformity.

The conformity assessment process varies by product category. Some products qualify for manufacturer self-assessment, while others require evaluation by an authorized Notified Body.

What is CE Marking?

CE marking is a declaration of product conformity with applicable EU harmonisation legislation. It allows products covered by CE marking requirements to be placed on the European Economic Area (EEA) market when the relevant legal obligations have been fulfilled.

The letters CE are commonly associated with the French expression Conformité Européenne, meaning European conformity.

The European Commission’s CE marking guidance explains that manufacturers are responsible for assessing conformity, preparing technical documentation, issuing the required declaration, and affixing the CE mark.

A CE-marked product indicates that:

• Applicable EU legislation has been identified.
• Relevant product requirements have been evaluated.
• Required conformity assessment procedures have been completed.
• Supporting technical documentation has been prepared.
• The manufacturer assumes responsibility for product conformity.

CE marking does not represent approval by the European Commission or another EU authority. It also does not indicate the product’s country of origin or guarantee that the product is free from defects.

Why Is CE Marking Required?

CE marking provides a common conformity framework for product categories regulated under relevant EU legislation.

Its primary functions include supporting legal market access, communicating regulatory conformity, and enabling market surveillance authorities to verify compliance.

Market Access Within the European Economic Area

Products covered by legislation requiring CE marking generally must bear the marking before being placed on the EEA market.

This applies to relevant products manufactured within Europe and products imported from other countries.

Once the applicable requirements have been fulfilled, CE marking supports the free movement of regulated products within the EEA.

Product Safety and Regulatory Compliance

EU product legislation establishes essential requirements designed to address risks associated with regulated products.

Depending on the product category, these may include:

• Electrical safety
• Mechanical hazards
• Fire and explosion risks
• Chemical exposure
• Electromagnetic compatibility
• Protective performance
• Medical device safety
• Other specified health and environmental requirements

The applicable legislation determines which requirements must be assessed.

Technical Documentation and Traceability

CE marking obligations commonly include maintaining technical documentation demonstrating conformity.

These records support regulatory inspections, product traceability, and investigations by market surveillance authorities.

Which Products Require CE Marking?

CE marking applies to products covered by specific EU harmonisation legislation.

The following table identifies common product categories and their principal legislative frameworks.

Product Category	Relevant EU Legislation	Typical Compliance Areas
Toys	Toy Safety Directive 2009/48/EC	Mechanical, chemical, physical, and flammability safety
Electrical equipment	Low Voltage Directive 2014/35/EU	Electrical safety
Electronic equipment	EMC Directive 2014/30/EU	Electromagnetic emissions and immunity
Radio equipment	Radio Equipment Directive 2014/53/EU	Radio spectrum, EMC, safety, and applicable additional requirements
Machinery	Machinery Directive 2006/42/EC	Mechanical safety and risk assessment
Personal protective equipment	Regulation (EU) 2016/425	Protective performance and safety
Medical devices	Regulation (EU) 2017/745	Safety, performance, and risk management
Construction products	Applicable Construction Products Regulation framework	Assessment and declaration of regulated product performance
Pressure equipment	Pressure Equipment Directive 2014/68/EU	Pressure-related safety
Gas appliances	Regulation (EU) 2016/426	Gas appliance safety and performance

This table provides general examples. Product classification, exclusions, applicable amendments, and specific legislative provisions determine the actual CE marking obligations.

Electrical and Electronic Products

Electrical and electronic equipment may fall under several EU legislative frameworks.

For example, a household electrical appliance may be subject to the Low Voltage Directive and EMC Directive, depending on its characteristics.

Other requirements, including restrictions on hazardous substances, may also apply.

A product must satisfy all applicable legislation before the manufacturer issues its declaration of conformity.

Toys

Toys placed on the EU market must meet applicable toy safety requirements and bear CE marking.

Safety assessment may involve mechanical hazards, flammability, chemical substances, electrical risks, and other relevant characteristics.

The EN 71 series provides technical standards frequently used to support toy safety conformity assessment.

As of November 2026, Directive 2009/48/EC remains applicable during the transition to the new Toy Safety Regulation (EU) 2025/2509, whose main provisions apply from 1 August 2030.

Machinery

Machinery covered by applicable EU machinery legislation must undergo the required conformity assessment before CE marking.

The assessment may involve risk analysis, protective measures, technical documentation, and verification against relevant safety requirements.

The Machinery Directive 2006/42/EC remains the principal framework during the current transition period.

Regulation (EU) 2023/1230 will generally apply from 20 January 2027.

Personal Protective Equipment

Personal protective equipment is regulated under Regulation (EU) 2016/425.

Relevant products include safety gloves, protective footwear, respiratory protective devices, and other equipment designed to protect against specified risks.

Conformity assessment requirements depend on the PPE category and the risks involved.

Medical Devices

Medical devices are regulated under the applicable EU medical device framework, including Regulation (EU) 2017/745.

Requirements vary according to device classification, intended purpose, and relevant conformity assessment procedures.

Many medical devices require Notified Body involvement, while certain lower-risk devices may follow manufacturer self-assessment procedures.

Do All Products Sold in Europe Need CE Marking?

CE marking is required only where the applicable EU legislation provides for it.

Many general consumer products, such as ordinary furniture and clothing, do not require CE marking solely because they are sold in Europe.

These products may still be subject to other mandatory safety, chemical, labeling, or market surveillance requirements.

The CE mark must not be applied to products outside the scope of legislation requiring it.

CE Marking Requirements

CE marking requirements depend on the product category and applicable EU legislation.

However, most conformity assessment processes involve several common obligations.

1. Identify Applicable EU Directives and Regulations

The first requirement is to determine which EU legislative acts apply to the product.

Product characteristics, intended use, technical functions, and foreseeable operating conditions influence the applicable requirements.

A product may fall under more than one regulation or directive.

For example, a wireless electrical device may be subject to the Radio Equipment Directive and other applicable product legislation.

2. Identify Applicable Technical Standards

Relevant harmonised European Standards may provide technical specifications and test methods for demonstrating conformity with particular legal requirements.

When a harmonised standard is cited in the Official Journal of the European Union, applying its relevant provisions may provide a presumption of conformity with the legal requirements covered by the citation.

The applicable edition and any restrictions must be verified.

For a detailed explanation, see our EN Standards Guide.

3. Conduct Product Risk Assessment

Risk assessment identifies hazards associated with a product’s intended and reasonably foreseeable use.

Depending on the product, the assessment may consider:

• Electrical shock
• Mechanical injury
• Fire and overheating
• Chemical exposure
• Electromagnetic disturbances
• Pressure-related hazards
• Other relevant safety risks

The risk assessment should correspond to the requirements of the applicable legislation.

4. Complete Required Testing and Verification

Testing provides evidence that the product satisfies specified technical requirements.

The necessary tests depend on the product category, relevant standards, and applicable conformity assessment procedure.

Testing may be performed internally or by an external laboratory where permitted.

Certain conformity assessment procedures require involvement of a Notified Body.

5. Prepare Technical Documentation

Technical documentation must contain sufficient information to demonstrate conformity with applicable requirements.

The content varies by legislation but commonly includes product specifications, design information, risk assessments, test results, and conformity assessment records.

6. Issue the EU Declaration of Conformity

For products requiring an EU Declaration of Conformity, the manufacturer must prepare and sign the declaration after completing the relevant conformity assessment.

The declaration identifies the product and applicable legislation and confirms the manufacturer’s responsibility for conformity.

7. Apply the CE Mark Correctly

The CE mark must be affixed according to the applicable legislation and marking requirements.

Its placement, dimensions, visibility, and accompanying identification information must meet the relevant provisions.

CE Marking Certification: Is a Certificate Required?

CE marking does not involve a universal certificate issued by the European Union.

The manufacturer is responsible for demonstrating conformity with applicable legislation and completing the prescribed conformity assessment procedure.

Some products can follow a self-assessment route. Others require independent assessment and certificates issued by a Notified Body within its designated scope.

CE Self-Declaration

Manufacturer self-assessment is permitted under certain EU conformity assessment procedures.

Where this route applies, the manufacturer is responsible for:

• Identifying relevant legal requirements
• Evaluating product risks
• Completing the required technical assessment
• Maintaining supporting documentation
• Issuing the EU Declaration of Conformity
• Affixing the CE mark

Independent testing may still be used to support the technical evidence.

Third-Party Conformity Assessment

Some products require assessment by a Notified Body.

The required activities may include product examination, technical documentation review, production quality assessment, or other procedures specified by the relevant legislation.

A certificate issued through a prescribed Notified Body procedure supports the applicable conformity assessment.

The manufacturer remains responsible for the product’s conformity with the relevant legislation.

CE Certificate vs CE Declaration of Conformity

Document	Purpose	Issued By
EU Declaration of Conformity	Declares conformity with applicable EU legislation	Manufacturer or authorized representative acting under the relevant legal provisions
Notified Body certificate	Records the outcome of a prescribed third-party conformity assessment	Designated Notified Body
Laboratory test report	Documents test methods, results, and relevant findings	Testing laboratory
Voluntary certificate	Records an assessment under a voluntary scheme	Relevant certification provider

A voluntary certificate does not replace mandatory conformity assessment or the EU Declaration of Conformity.

The European Commission’s conformity assessment guidance explains the importance of verifying whether independent assessment is legally required.

What Is a Notified Body for CE Marking?

A Notified Body is a conformity assessment organization designated by an EU member state to perform specified activities under relevant EU legislation.

Notified Bodies operate within defined scopes of designation.

Depending on the legislation and assessment procedure, their activities may include:

• EU-type examination
• Technical documentation review
• Product conformity evaluation
• Quality assurance assessment
• Production surveillance
• Other prescribed conformity assessment activities

When Is a Notified Body Required?

The requirement depends on the product category, classification, and conformity assessment procedure.

Examples include certain categories of PPE, medical devices, and other regulated products.

Notified Body involvement must be determined from the applicable legislation.

How to Verify a Notified Body

The European Commission maintains the NANDO database, which identifies organizations notified under relevant EU legislation.

Before engaging a Notified Body, verify:

1. The organization’s identification number.
2. The legislation under which it is notified.
3. Its designated product or assessment scope.
4. The conformity assessment procedures it is authorized to perform.

A laboratory’s ISO/IEC 17025 accreditation alone does not establish Notified Body status.

CE Marking Testing Requirements

CE testing refers to technical testing performed to support conformity with applicable EU product requirements.

There is no single test procedure covering every CE-marked product.

The required testing scope depends on the product, applicable legislation, and relevant technical standards.

Common Types of CE Testing

Testing Area	Typical Evaluation
Electrical safety	Protection against electrical hazards, insulation, temperature, and other specified requirements
EMC testing	Electromagnetic emissions and immunity
Mechanical safety	Stability, strength, moving parts, and relevant mechanical hazards
Chemical testing	Restricted substances and applicable material requirements
Flammability testing	Fire-related performance under specified conditions
PPE testing	Protective performance against identified hazards
Radio testing	Applicable radio spectrum and related technical requirements

Specific methods and acceptance criteria must be established from the applicable legislation and standards.

What Should a CE Testing Report Include?

Depending on the test method and laboratory, a report may contain:

• Product and sample identification
• Applicable test standards and editions
• Testing methods
• Test conditions
• Equipment or sample configuration
• Measured results
• Applicable limits or acceptance criteria
• Statements of conformity where supported
• Observations and limitations

The report should clearly identify the tested product and the scope of evaluation.

Does CE Testing Require an Accredited Laboratory?

Accreditation requirements depend on the applicable legislation and conformity assessment procedure.

ISO/IEC 17025 accreditation demonstrates laboratory competence for activities within the laboratory’s accredited scope.

Where accredited testing is required, the laboratory’s scope should be checked to confirm that it covers the relevant methods.

A laboratory test report alone does not complete every CE marking obligation.

CE Marking Technical Documentation Requirements

Technical documentation provides the evidence supporting a product’s conformity with applicable EU legislation.

The required content varies by product category.

Common documentation includes:

• Product description and intended use
• Model and product identification
• Design drawings and technical specifications
• Materials and component information
• Applicable regulations and directives
• Standards and technical specifications applied
• Risk assessment records
• Test reports and evaluation results
• Manufacturing and quality control information
• Relevant conformity assessment certificates
• Instructions and safety information
• EU Declaration of Conformity

How Long Must CE Technical Documentation Be Retained?

Many EU product frameworks require technical documentation and the declaration of conformity to be retained for 10 years after the product is placed on the market.

The applicable legislation determines the precise retention period, responsible party, and any additional obligations.

Documentation must be made available to competent authorities when required.

When Should Technical Documentation Be Updated?

Documentation should be reviewed when changes may affect conformity.

Examples include:

• Product redesign
• Material substitutions
• Component changes
• Manufacturing process changes
• Changes in intended use
• Updates to relevant legislation
• Revisions to applicable technical standards

Where changes affect the product’s compliance, additional assessment or testing may be necessary.

EU Declaration of Conformity (DoC)

The EU Declaration of Conformity is a legal document through which the manufacturer declares that a product meets the applicable EU requirements.

The declaration must be prepared according to the relevant legislation.

Common information includes:

• Manufacturer’s name and address
• Product model or identification
• Statement of responsibility
• Applicable EU directives or regulations
• Relevant harmonised standards or other technical specifications
• Notified Body details where applicable
• Name and position of the authorized signatory
• Signature and date of issue

The declaration should be updated when relevant changes affect its accuracy.

The European Commission’s EU Declaration of Conformity guidance explains the manufacturer’s responsibilities and typical documentation requirements.

CE Marking Symbol and Labeling Requirements

The CE marking symbol must follow the proportions and placement requirements established by the applicable EU legislation.

General requirements include:

• The marking must be visible and legible.
• It must be affixed indelibly where required.
• The prescribed proportions must be maintained.
• The minimum height is generally 5 mm, unless specific legislation provides otherwise.
• Placement on packaging or accompanying documents may be permitted where the product cannot be marked as required by the applicable rules.

Where the relevant conformity assessment procedure requires it, a Notified Body identification number must accompany the CE marking.

Can CE Marking Appear on Packaging?

The applicable legislation determines the permitted marking location.

CE marking is generally affixed to the product or its data plate.

Where product marking is impracticable or otherwise addressed by the relevant legislation, marking on packaging and accompanying documents may be permitted or required.

Can a Product Carry Multiple Compliance Marks?

A product may carry CE marking alongside other required or permitted markings.

Additional markings must comply with applicable rules and must not mislead users or reduce the visibility, legibility, or meaning of the CE mark.

Who is Responsible for CE Marking Compliance?

Different economic operators have responsibilities under applicable EU product legislation.

Manufacturers

Manufacturers are generally responsible for ensuring product conformity and completing the prescribed conformity assessment.

Their obligations may include technical documentation, testing, declarations, labeling, traceability, and corrective action.

A company selling a product under its own name or trademark may be treated as the manufacturer under applicable legislation, including where production is outsourced.

Importers

Importers placing products from outside the EU on the EU market have specific verification and compliance obligations.

Depending on the legislation, these may include checking that:

• Required conformity assessment has been completed.
• Appropriate technical documentation exists.
• CE marking is correctly applied.
• Required declarations and instructions are available.
• Manufacturer and importer identification requirements are met.

Distributors

Distributors have obligations relating to product conformity, labeling, documentation, and cooperation with market surveillance authorities.

The applicable requirements depend on the product legislation and the distributor’s role.

Authorized Representatives

Manufacturers may appoint an authorized representative to perform specified tasks under a written mandate where permitted.

The scope of responsibility depends on the applicable legislation and the terms of the mandate.

Common CE Marking Compliance Problems

CE marking compliance problems frequently arise from incorrect product classification, incomplete technical evidence, and inconsistencies between assessed products and production units.

Incorrect Identification of Applicable Legislation

A product may fall within the scope of multiple regulations or directives.

Missing one applicable framework can result in an incomplete conformity assessment.

Using Incorrect or Outdated Standards

Testing against an unsuitable standard or edition may leave relevant requirements unaddressed.

Harmonised standard references, amendments, and transition arrangements should be checked before testing.

Incomplete Technical Documentation

Missing drawings, risk assessments, test records, or conformity documentation may create problems during regulatory review.

Documentation should be complete, traceable, and consistent with the product placed on the market.

Unverified Certification Claims

A certificate may have limited relevance if the issuing organization lacks the required designation or the assessment falls outside its authorized scope.

Notified Body status and assessment scope should be verified where mandatory third-party involvement applies.

Product Changes After Testing

Changes to components, materials, suppliers, or manufacturing processes may affect product conformity.

Quality control procedures should identify changes that require technical review or additional testing.

Incorrect CE Marking Placement

Incorrect dimensions, unsuitable placement, missing required identification information, or unauthorized use of the CE mark may create compliance concerns.

CE Marking and Production Quality Control

Product conformity must be maintained throughout production.

A product that passes initial testing may require additional review when its design, materials, components, or manufacturing processes change.

Quality control activities can support production consistency by checking whether manufactured units correspond to approved specifications and assessed product configurations.

Relevant activities may include:

• Supplier and component verification
• Pre-production specification review
• In-process quality inspections
• Finished product inspections
• Product testing
• Packaging and labeling verification
• Documentation review

For products manufactured through multiple suppliers or production locations, consistent specifications and change-control procedures are particularly important.

Inspection findings and laboratory test results can provide supporting evidence for production quality management.

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CE marking requires accurate product classification, compliance with applicable EU legislation, appropriate conformity assessment, and complete technical documentation. Verify the relevant requirements and assessment route before applying the CE mark or placing regulated products on the European market.