Studies to notify

The following clinical evaluations must be notified :

-Clinical studies conducted with medical devices that do not bear the CE marking

-Clinical studies conducted with medical devices that bear the CE marking but are used for another indication than the one for which it has been accepted

Contact :

Carine Bakwa

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

Tel. : +32 (0)2 524 83 39
Fax : +32 (0)2 524 81 20

Email : meddev@afmps.be