- 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.
Please refer to the following decision tree to determine if an incident is reportable. :
Federal agency for medicines and health products
Place Victor Horta 40, box 40
Tel. :+32 (0)2 528 40 00
Fax : +32 (0)2 528 41 20
E-mail : firstname.lastname@example.org