Documentation for CE Mark

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CE marking (also known as CE mark) is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The marking certifies that a product has met European Directives regarding consumer safety, health or environmental requirements.

The manufacturer of a product himself affixes the CE marking to it, but has to take certain obligatory steps before he product can bear CE marking. He has to carry out a conformity assessment, set up a technical file and sign an EC declaration of conformity. The documentation has to be made available to authorities on request.

Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Importers should also make sure that contact with the manufacturer can always be established.

Distributors must be able to demonstrate to national authorities that they have acted with due care and must have affirmation from the manufacturer or importer that the necessary measures have been taken.

CE marking does not indicate that a product was made in the EEA,[6] but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant “essential requirements” (e.g. safety, health, environmental protection requirements) of the applicable directive(s) – or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.

Depending on the level of risk of the product, the CE Mark is affixed to a product by the manufacturer or authorised representative who decides whether the product meets all the CE mark requirements. If a product has minimal risk it can be self certified where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product. In doing this the manufacturer has to do several things:

  • Decide whether the product needs to have a CE mark and if the product applies to more than 1 directive it needs to comply with all of them;
  • Choose the conformity assessment procedure from the modules called out by the directive for the product;