You are searching for keyword: {{ keyword }}

The CE Marking Process (6 Simple Steps)

01/06/2021 Ferry Vermeulen Law and Legislation

Step 4 of the CE Marking Process: Test the Product and Check its Conformity

How do you know that your product complies with the essential requirements in the applicable directives? 

You will have to test and document that your product actually conforms. Each directive outlines which conformity assessment procedures – also referred to as modules – a manufacturer can undertake.

There are 8 conformity assessment modules. The applicable directives outline which module(s) apply to a particular product category.

  • Module A: Internal production control
  • Module B: EC type examination
  • Module C: Conformity to type
  • Module D: Production quality assurance
  • Module E: Product quality assurance
  • Module F: Product verification
  • Module G: Unit verification
  • Module H: Full quality assurance (EN ISO 9001)

Step 5 of the CE Marking Process: Draw up and Keep Available the Required Technical File

All CE marking directives impose an obligation for the manufacturer to create and make available a technical file (or technical documentation) containing information which demonstrates that the product conforms to the requirements of the directive.

A technical file relevant to a CE-marked product must be kept for at least 10 years from the last date the product was manufactured, unless the directive provides for a later date.

The technical file must be provided to enforcement authorities on demand, often within short timelines. The technical file needs to be kept up to date, especially when the product is modified or is subject to updated conformity assessment procedures.

Each directive has different requirements on what should be in the technical file. As an example, the technical file for Low Voltage products should contain:

  • a general description of the electrical equipment;
  • conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.;
  • descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the electrical equipment;
  • a list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union or international or national standards referred to in Articles 13 and 14 and, where those harmonised standards or international or national standards have not been applied, descriptions of the solutions adopted to meet the safety objectives of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards or international or national standards referred to in Articles 13 and 14, the technical documentation shall specify the parts which have been applied;
  • results of design calculations made, examinations carried out, etc.
  • test reports

Step 6 of the CE Marking Process: Affix the CE Marking and Draw up the EU Declaration of Conformity

Once the technical file has been completed, as a manufacturer you can declare compliance with the directives by drafting and signing the Declaration of Conformity (see here for DoC templates).

The Declaration of Conformity is an acknowledgement by the manufacturer that they are responsible for the compliance of their products with the applicable directives.

The declaration should be available to authorities at the EU point of entry. The Declaration of Conformity generally includes the following:

  • who you are
  • what product it refers to
  • what directives are involved
  • which standards have been used
  • where test results can be found
  • who is responsible in your company