CE Marking Services

CE marking is mandatory to be able to sell many products in the EU. The requirements are driven by directives or regulations - legislation drafted and approved by the European Commission that must be integrated into the legal systems of all Member States. Most directives or regulations are intentionally vague about specific requirements for testing and compliance and focus on two key elements:

1. Essential requirements: Core safety and performance requirements that must be met for CE marking
2. Minimum requirements: Technical details contained in harmonized standards that can be updated without changing the legal text

Determining which directive(s) or regulation(s) applies to your product can be challenging, considering that most  are written in a legal form rather than for laypersons, and the necessary detail is often buried in the directive or regulation itself.

An essential step in compliance with a directive or regulation is performing a risk assessment. This is the process where a manufacturer identifies all the hazards covered by the directive or regulation and then mitigates these hazards through a test assessment (typically using a harmonized standard(s)) or through a modification to the design, labelling, or instructions  

For most products, CE marking follows an 8-step process to certification.

Although it may seem like a complicated process, obtaining a CE Mark can be reduced to a relatively simple set of steps. Our experts can assist in every stage of this journey, from determining the appropriate requirements to maintenance testing.

The CE marking process includes:

• Determining the applicability and requirements of the directive(s) and regulation(s)
• Identifying the appropriate standard (includes involving a Notified Body as needed and creating a test plan)
• Performing the testing / applying the standards
• Compiling technical information (includes completing a Notified Body review if needed and issuing a Notified Body Type Examination certificate or Statement of Opinion (SoO) if required)
• Generating a Declaration of Conformity (DoC)
• CE Marking equipment
• Placing equipment on the market (putting the product into service)
• Maintaining compliance through regular testing and auditing

Three key risks exist: (1) self-declaring without sufficient evidence to support the essential requirements; (2) lack of expert knowledge of the test standards, and (3) ensuring product safety beyond functional acceptability. Third-party testing helps mitigate these risks and prevent costly recalls.  

Third-party testing from an accredited laboratory ensures products meet fire safety requirements, have suitable electrical isolation, prevent shock hazards, and include clear safety instructions. A third-party report differentiates the CE marking from self-declaration which increases credibility with retailers and consumers while enabling access to global markets. While self-declaration is possible for some product categories, third-party testing provides crucial evidence to support your declaration and protect against costly recalls or legal issues.  

Element provides access to major international electrical safety certification schemes, including the IECEE CB Scheme (operating in 50+ countries), IECEx Scheme (operating in 50+ countries), CE marking (Europe and United Kingdom), and NRTL/SCC certification (United States and Canada).  

CE marking is a mandatory requirement for EU market access. While the 8-step CE marking process may seem complex, our experts bridge the knowledge gap, guiding you at every stage from identifying requirements to maintenance testing. The process is as follows:

• Determining the requirements
• Identifying the appropriate standards (includes involving a Notified Body as needed and creating a test plan)
• Performing the testing / applying the standards
• Compiling technical information (includes completing a Notified Body review, if needed, and issuing a Statement of Opinion (SoO) if required)
• Generating a Declaration of Conformity (DoC)
• Affixing the CE Marking on products/equipment
• Placing equipment on the market (putting the product into service)
• Maintaining compliance through regular testing and auditing

If you need guidance tailored to your business, Element’s CE Marking Training courses, led by seasoned experts, offer flexible packages to address your questions and provide best practice guidance.

If you require guidance on the CE Marking process and how it applies to you and your products, Element’s CE Marking training courses are delivered by seasoned subject experts. They can address your questions and provide best practice guidance with flexible standard and bespoke packages to meet your business and staff needs.