European Medical Device Directives

Gain market access in Europe by complying with the Medical Device Directives

European Directives medical devices BSIThe 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 relevant Directive have to be met and a CE mark applied.

As a Notified Body for CE Marking, our certificates are acknowledged as trusted certificates by authorities, suppliers, and manufacturers around the world. Because of this recognition, certification through us can help you obtain approval in global markets.