Definition

The purpose of materiovigilance is to study and follow incidents that might result from using medical devices. It enables dangerous devices to be withdrawn from the market and to eliminate faults in medical devices with the intention of constantly improving the quality of devices and providing patients and users with increased safety.

Article 11 of the Royal decree dated 18/03/1999 (French version) concerning medical devices and  Article 12 of the Royal decree dated 15/07/1997 (French version) concerning active implantable medical devices describe the measures to be taken in the event of accidents taking place on Belgian territory. You can find further information in circular 421 .  However the address, telephone number, fax number, and e-mail address shown in this circular (which dates back to 25/02/2003) are no longer correct. The new details are as follows:

Federal agency for medicines and health products
"Vigilance" division
Eurostation II
Place Victor Horta 40, box 40
B-1060 Brussels
Tel. :+32 (0)2 528 40 00
Fax : +32 (0)2 528 41 20
E-mail : meddev@afmps.be

Materiovigilance only refers to medical devices whereas pharmacovigilance refers to medicines.

Last updated on 14/07/2016