CE Mark requirement identification 

Determining the specific EU directives and standards applicable to your product for CE marking.

Essential Requirements Assessment 

Evaluating your product design and technical features against mandated EU safety and performance criteria.

Tailored Testing Programs 

Conducting relevant electrical, EMC, and radio testing to demonstrate product conformity with the essential requirements of relevant CE Directives. 

Technical File Compilation* 

Assisting in creating accurate and complete technical documentation required to support your CE Declaration of Conformity. 

Declaration of Conformity Guidance* 

Supporting you in drafting and verifying your CE Declaration of Conformity for accuracy and legal compliance.  

Compliance Strategy Support* 

Offering comprehensive guidance from product design through market placement to achieve and maintain CE marking.  

Regulatory Updates & Training*

Keeping you informed on evolving CE marking requirements and providing relevant training workshops. 

Notified Body Conformity Assessment* 

Providing mandatory third-party assessment and certification for products requiring Notified Body involvement for CE Marking 

*Please note that some services are not available when third-party conformity assessment services are provided from our EU Notified Bodies. 

We go beyond testing, ensuring that your product is not only technically compliant but that the administrative compliance for your product is correct, allowing you to use a CE mark to demonstrate compliance with the essential requirements of all relevant EU Directives.

We help with:

• Identifying Applicable Directives and Regulations: 
• Meeting Essential Requirements with compliance strategies and test plans
• Performing Conformity Assessments
• Using a Notified Body (if required)
• Compilation and checking of Technical Documentation including the Declaration of Conformity (DoC) and the Technical File
• Correct labelling including the CE mark and other key markings needed to place a product onto the EU market
• Maintaining Compliance with on-going reviews, updates and support

CE Marking Requirements

CE marking is a mandatory conformity marking for many products placed on the single market in the European Economic Area (EEA). It signifies that a product meets the essential requirements of all relevant European directives and regulations.

Key requirements for CE marking include:

• Identifying Applicable Directives and Regulations: Determine which specific EU directives and regulations apply to your product. The requirements vary significantly depending on the product category (e.g. electrical equipment, medical devices, machinery, personal protective equipment).
• Meeting Essential Requirements: Ensure your product technically complies with the essential requirements outlined in the applicable directives. These requirements cover aspects such as safety, health, and environmental protection.   
• Performing Conformity Assessment: Carry out the necessary conformity assessment procedures. This may involve self-declaration by the manufacturer or require involvement from a Notified Body, depending on the risk level of the product and the requirements of the directives.
• Using a Notified Body (if required): For certain products, independent testing, certification, or inspection by a Notified Body is mandatory. A Notified Body is an organization designated by an EU Member State to assess the conformity of products before they are placed on the market.   
• Technical Documentation: Compile a technical file containing all relevant information demonstrating the product's conformity with the applicable directives and regulations. This documentation must be kept for a specified period and made available to market surveillance authorities if requested.
• Declaration of Conformity (DoC): Issue a Declaration of Conformity, a legal document signed by the manufacturer (or authorized representative) stating that the product meets all relevant requirements.
• Affixing the CE Mark: Once conformity is demonstrated and the necessary documentation is in place, the CE mark must be affixed to the product, its packaging, or accompanying documents. The marking must be visible, legible, and indelible.
• Maintaining Compliance: Ongoing compliance is crucial. Manufacturers must ensure that products continue to meet the requirements as long as they are placed on the market, including accounting for any changes in design or regulations.

Global Expertise and Network 

With a worldwide presence and a network of accredited laboratories, we offer extensive knowledge of EU Directives and the requirements of those Directives, providing local support with global reach. 

Integrated Testing and Certification

We provide a comprehensive suite of testing, certification and compliance services under one roof, simplifying the CE marking process and reducing time to market for your products. 

Notified and Approved Body Status*

As EU Notified and UK Approved Bodies for numerous directives and regulations, we can provide mandatory third-party conformity assessments required for market entry where self-declaration is not sufficient.

Tailored Solutions and Technical Guidance*

The team of compliance experts at Eurofins Electrical & Electronics offers customised testing plans, assists with technical documentation, and provides expert guidance throughout the entire product compliance lifecycle, addressing your specific needs and building confidence.

*Please note that some services are not available when third-party conformity assessment services are provided from our EU Notified Bodies.