New legislation relating to active implantable medical devices

Directive 2007/47/EC and the Royal Decree of 21.01.2009 include a revision of the provisions applicable to active implantable medical devices. The main changes relate to clinical investigations, essential requirements, definitions and vigilance, whose rules have been refined, improved and completed. The coherence between the various directives on medical devices has also been restored. These provisions come into force on 21.03.2010.

At the national level the Royal Decree of 21.01.2009 provides for a merger of the Evaluation Commission for active implantable medical devices and the Evaluation Commission for medical devices. This is to better utilize the available expertise. The Commission will respond quickly, efficiently and with all the expertise necessary to dossiers submitted to it. These provisions at the national level come into force on 30.04.2009.

The Royal Decree transposing the Directive 2007/47/EC concerning medical devices is expected soon.