CE marking of the medical devices

europe map with CE marking logo

CE Marking and Compliance

The CE marking is an indicator signifying that the product complies with EU legislation and enables the free movement of products within the European market. When a manufacturer to affix the CE marking on a product, he declares on his sole responsibility, conformity with all legal requirements of CE marking. Thus, product can be sold in the economic area Europe, Switzerland and Turkey.

This also applies to products manufactured in third countries which are sold in the European Economic Area (EEA), Switzerland and Turkey. The CE marking doesn’t indicate that the product is manufactured in the EEA but indicates the product is assessed before being placed on the market and meets the security requirements, health and environmental protection of the European Union. This means that the manufacturer has verified that the product complies with essential requirements of the applicable Directives.

It is the manufacturer’s responsibility to carry out the conformity assessment, to establish the technical file, to issue the CE declaration of conformity and to affix the CE marking to that product. Distributors must verify the presence of both the CE marking and supporting documentation.

The products subject to specific Directives must affix the CE marking. There are more than 20 Directives on categories requiring CE marking. The essential requirements of products are harmonized  in the European Union and are defined in general terms in the Guidelines.

The harmonized European standards are issued with reference to the applied directives and express in terms of the essential requirements. Full compliance of a product with harmonized standards gives the “presumption of conformity” of this product with essential requirements. While the CE marking is mandatory, the use of harmonized standards is voluntary. Other ways to meet these essential requirements can be chosen.

Evaluation of compliance

All conformity assessment activities aim to test or prove that the product complies with the essential legal requirements. Manufacturers must indicate the conformity assessment procedure to be followed; this can be a self-declaration, involve testing inspection or assessment of the quality system with a notified body or a combination of both. The global approach was specified by the modular approach for the assessment of compliance with the Guidelines. There are independent modules, indivisible and complementary.

Notified bodies

Each directive covering a product indicates whether an authorized third party (notified body) must be involved in the evaluation procedure of conformity required for CE marking. These agencies are authorized by the national authorities and officially “notified” to the European Commission.

Technical documentation

The manufacturer shall establish the technical documentation required by the Guidelines for the assessment of conformity of the product with the appropriate requirements, and risk assessment. With the declaration of conformity of the European Commission, the technical documentation must be presented on request to the competent national authorities.

Product importers must verify that the manufacturer outside the EU has taken the necessary steps and that the documentation is available on request. If importers or distributors market the products under their own name, they support the manufacturer’s responsibility. In this case, they must have sufficient information on the design and manufacture of the product, as they will assume legal responsibility when they affix the CE marking.

Affix the CE marking

The CE marking must be affixed by the manufacturer or his authorized agent. If a notified body has been involved in the production control phase, its identification number must be displayed. The CE marking on a product indicates to state officials that the product may be legally placed on the market in their country. Where products are subject to several Directives, which are all related to the CE marking, the marking indicates that the products are presumed to comply with these Guidelines.

Declaration of conformity

It is the manufacturer’s responsibility to draw up and sign a “declaration of conformity of the European Commission” proving that the product meets the requirements. Once the CE marking on a product, it must be supported by a formal statement of compliance : the manufacturer declares that the product complies with the essential requirements outside European Directives in force. Before that, the product can not be sold on the European market.