CE Mark Overview

The CE Mark or CE Certification is a mandatory conformance mark that certifies that a product has met EU consumer safety, health or environmental requirements. CE originally stood for “Communauté Européenne” or “Conformité Européenne”.

The CE Marking is mandatory for certain product groups in the European Economic Area (EEA), consisting of the 27 Member States of the European Union (EU) and European Free Trade Association (EFTA) countries Iceland, Norway and Liechtenstein. It is also obligatory for all products made in third countries (non-member states) which are sold in the EEA. In that case, the importer has to make sure that the manufacturer outside the EU has taken the necessary steps that allow him to affix the CE Marking.

The CE Mark is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE Marking on a product, a manufacturer is declaring, on its sole responsibility, conformity with all of the legal requirements to achieve CE Marking and therefore ensuring validity for that product to be sold throughout the European Economic Area.

CE Mark impacts manufacturers, importers and distributors as detailed below:

Manufacturers must complete a conformity assessment, set up a technical file and sign an EC declaration of conformity prior to affixing a CE Mark to its product. Products may only be placed on the market if they comply with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly.

Importers must verify that the manufacturer outside the EU has completed the required steps to affix a CE Mark to the product. Importers must also confirm that the CE Mark documentation is available upon request.

Distributors must be able to produce sufficient documentation confirming that the manufacturer and importer have completed all steps necessary to affix a CE Mark to a product.

Keystone Compliance assists manufacturers with CE Mark compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your CE Mark needs.

For more specific information about the CE Mark, please use the following links: