Who should notify?
Not only the manufacturers or their representatives but also persons distributing devices, notified bodies, practitioners and people responsible for receiving and/or delivering devices should all signal incidents to : Federal Agency for Medicines and Health Products – Department Medical Devices.
Contact :
Federal Agency for Medicines and Health Products
Department « Medical Devices »
Eurostation II
Place Victor Horta 40, box 40
B-1060 Brussels
Tel. :+32 (0)2 524 82 20/ 81 78
Fax : +32 (0)2 524 81 20
E-mail : meddev@afmps.be