CE marking of medical devices

The letters CE stand for Conformité Européenne which means 'in accordance with the European regulatory requirements’. The CE marking on a product indicates that it meets the rules within the European economic area (EEA: the European Union plus Iceland, Norway, and Liechtenstein).

 

The CE marking is not a quality mark. The procedures for affixing the CE marking are based on EU-Council directive 93/465/EEC. The reason for this decision is "Europe 1992" in which the free movement of persons and goods are being pursued. The different national requirements that were in effect until then were void. The aim of the CE marking is the promotion of free trade within the Member States and to increase safety in the use of the product.

 

Through treaties such as the convention of Rome, most recently and the Treaty of Lisbon, it was agreed that the Member States translate and implement the European regulations, within the time limit laid down in the Treaty, into their national legislation. This is why we speak in practice of "European law".

 

With the affixing of the CE marking, the manufacturer declares that the product meets all applicable European rules and that compliance or conformity assessment procedures have been completed. In addition, he must have drawn up a declaration of conformity for these products. In this declaration of conformity, the manufacturer indicates that the product complies with all applicable European directives. Therefore the manufacturer is liable for its product.

 

The examination of the conformity with the regulations for low-risk products is based on self-certification. In that case, the manufacturer shall affix the CE logo on the product, or if this is not possible, on the immediately enclosing packaging. For higher-risk products, the manufacturer must first approve of a notified body. The notified body verifies that the product meets the requirements of the European directive. After approval by the notified body, the manufacturer must indicate this by the CE logo with the number of the notified body.