How should incidents be notified?

For users out of the care settings (doctors, pharmacists ...):

Please provide all available data and at least the data concerning the headings in bold type on the form. If you do not have all the other requested data, do not wait till you have that information but send the form without delay to the address given below.

Notification form (in French)

The notifications are handled confidentially.

 

For the care settings (hospital, rest home,...)

The notification will be done principally via the materiovigilance contact point (link vers ' who should notify? ') of your care setting or via his/her substitute.

Please provide all available data and at least the data concerning the headings in bold type on the form. If you do not have all the other requested data, do not wait till you have that information but send the form without delay to the address given below.

Notification form (in French)

The notifications are handled confidentially.

 

For the distributors:

The notification will be done principally via the materiovigilance contact point (link vers ' who should notify? ') of your company or via his/her substitute.

Please provide all available data and at least the data concerning the headings in bold type on the form. If you do not have all the other requested data, do not wait till you have that information but send the form without delay to the address given below.

Notification form (in French)


For manufacturers and  authorised representatives

Incident notification form
FSCA notification form  (Field Safety Corrective Action)

These forms, having been duly completed, should be sent to the following address:

Federal agency for medicines and health products
"Vigilance" division
Eurostation II
Place Victor Horta 40, Box 40
B-1060 Brussels
Tel. : +32 (0) 2 524 80 00
Fax: +32 (0) 2 524 81 20
Email: meddev@afmps.be

For further information please refer to the European commission website (http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm)

Last updated on 09/11/2017