What shall be notify?

- any dysfunction or any change of the characteristics and/or performance of a device, and any inadequacy in the labelling or instructions, which might lead to or have led to death or serious relapse in the state of health of a patient, a user or a third party.

- any technical or medical reason related to the characteristics or performance of a device for reasons shown in the previous paragraph and having led to the systematic withdrawal from the market by a manufacturer of devices of the same type.

Note: this relates to all medical devices that are marketed and also those that are intended for clinical investigations.

Not only must one notify serious incidents which have actually taken place but also the cases where there was a risk of a serious incident but that incident was avoided thanks to the attention and action of the relevant people.

An incident is considered serious if it has one of the following consequences or could have had such a consequence:

-         death, an illness or a handicap
-         a permanent lesion of a function or structure
-         the need for a medical or surgical operation
-         for a prolongation of a surgical operation
-         incorrect results of examinations leading to an incorrect diagnostic or treatment

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