How should incidents be notified?

Various forms are available:

For users (physicians, pharmacists ...):
Incident Reporting Form (DOC, 123 Kb) 
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.
The notifications are handled confidentially.

For manufacturers, authorized representatives and persons who trade in medical devices:

- Incident Report Form (PDF, 522.73 Kb) 
- FSCA (DOC, 105 Kb)  (Field Safety Corrective Action) report form

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

Federal Agency for Medicines and Health Products
DG POST
"Vigilance" division
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
Email: meddev@afmps.be

For further information please refer to the European commission website