CE Marking - Rules Underlying CE Marking

Rules Underlying CE Marking

Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer.

The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must 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 they must have affirmation from the manufacturer or importer that the necessary measures have been taken.

If importers or distributors market the products under their own name, they take over the manufacturer's responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking.

There are certain rules underlying the procedure to affix the marking:

• Products subject to certain EC directives providing for CE marking have to be affixed with the CE marking before they can be placed on the market.
• Manufacturers have to check, on their sole responsibility, which EU directives they need to apply for their products.
• The product may be placed on the market only if it complies with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly.
• The manufacturer draws up an EC declaration of conformity and affixes the CE marking on the product.
• If stipulated in the directive(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure.
• If the CE marking is affixed on a product, it can bear additional markings only if they are of different significance, do not overlap with the CE marking and are not confusing and do not impair the legibility and visibility of the CE marking.