Clinical evaluation

The method of clinical investigation 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) relating to medical devices (converting the European directive 90/385 ) 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.

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

-         Studies to be notified
-         Contents of the notification file
-         Procedure for notification
-         Adverse events 
 
Contact : 

Federal Agency for Medicines and Health Products 

R&D Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Email : meddev@afmps.be

Last updated on 15/12/2015