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
Email : meddev@afmps.be