Medical Device Regulation
Are you prepared for the changes??

The European Union (EU) regulatory framework for medical devices consists of the Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC.

In the interest of simplification, both directives are combined under the MDR, which is introduced as a regulation instead of a directive, following a proposed revision by the European Commission on 26 September 2012.

A regulation was deemed the appropriate legal instrument as it imposes clear and detailed rules which do not give room for different interpretations by member states.

More information is in this guide.