Clinical evaluation

The method of clinical evaluation for active implantable medical devices are described in article 8 of the Royal Decree dated 15/07/1997 (French version)  amended by the Royal Decree dated 10/12/2002 (French version) and by the Royal Decree dated 21/01/2009 (French version) (+1 appendix) (DOC, 164 Kb) relating to medical devices (converting the European directive 90/385 (PDF, 157.71 Kb) ) and those concerning the other medical devices in article 9 of the Royal Decree dated 18/03/1999 (French version) converting the European directive 93/42 (PDF, 268.68 Kb).

 Information about the clinical evaluations is available in the following sections:

-         Studies to be notified
-         Contents of the notification file
-         Procedure for notification

Contact :

Carine Bakwa

Federal Agency for Medicines and Health Products 
Health Products Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Email : meddev@afmps.be