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 the federal agency for medicines and health products – Unit materiovigilance

Materiovigilance contact points were set up within the care settings and distributors to facilitate the notification. Specific tasks have been attributed to these contact points  like incident notification.  These are resumed below:

-          Within the care settings

Designation: designation form contact point (in French)

Roles: role contactpoint (in French)

What shall be notified: cfr. ‘What shall be notify’ ?

Notification form: cfr. ‘How should the incidents be notified’?

-          At the distributors

Designation: via SADN - ABGD

Roles: role contact point (in French)

What shall be notified: cfr. ‘What shall be notify’ ?

Notification form: via SADN - ABGD

Contact :

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

 

Last updated on 14/07/2016