European market access

CE marking approval and certification

European market accessA medical device can only be sold in Europe with a CE mark. By placing the CE mark on a product, the manufacturer declares that their product complies with all applicable European Medical Device Directives. As a full scope Notified Body for medical device CE marking, we can issue device-specific CE certificates and Declarations of Conformity for your Class I sterile or measuring, Class IIa, Class IIb, or Class III device.

Class I devices that are not sterile or complete a measuring function do not require a certificate from a Notified Body, these products are self-certified by the manufacturer.


How are medical devices regulated in the European Union?

The Medical Device Directives are 'New Approach' directives relating to the safety and performance of medical devices which were harmonized in the EU in the 1990s. For a manufacturer to legally place a medical device on the European market the requirements of the Directive have to be met. Manufacturers' products meeting 'harmonized standards' have a presumption of conformity to the Directive. Products conforming with the Directive must have a CE mark applied. Without the CE mark, the marketing or distribution of the product within the European market is not allowed. The core legal framework consists of three directives:

They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.


Revision of the Medical Device Directives

On 26 September 2012, the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices which will, once adopted by the European Parliament and by the Council, replace the existing three Medical Device Directives. Read the proposals and other related documents.


How can BSI help you achieve compliance with the European Medical Device Directives?

BSI employs over 100 medical device experts with experience in all aspects of the product lifecycle including research and development, manufacturing, and quality assurance. We offer specialized in-house expertise in areas ranging from sterilization processes, and animal tissue utilization to combination medical device products.

A product may be within the scope of one or more EU Medical Device Directives, and the manufacturer can usually choose under different conformity assessment procedures. Some of them require a Notified Body to be involved.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: