Competences and role of authorities

There are three main European directives about the different categories of medical devices. They have been integrated into Belgian law.

- Directive 90/385/EEC (PDF, 157.71 Kb) concerning active implantable medical devices.

- Directive 93/42/EEC (PDF, 268.68 Kb) concerning medical devices.

- Directive 98/79/EEC (PDF, 188.44 Kb) concerning in vitro diagnostic medical devices. 

Each Member State designates the competent authority for each directive. The department of medical devices is the competent authority for Belgium concerning  directives 90/385/EEC and 93/42/EEC (medical equipment that can be actively implanted and medical equipment).

The competent authority for  in vitro diagnostic medical devices  (Directive 98/79/EEC) is the Scientific Institute for Public Health – l’Institut scientifique de santé publique (WEB), section Biologie Clinique.

The role of the competent authority

The main task of the competent authority is to watch over the market. In particular it must check the following operations :

- advise about the market launch of medical equipment.

- advise about exporters and distributors

- advise about clinical studies with medical equipment that are conducted on Belgian territory

- advise about incidents that occurred with medical equipment when on Belgian territory

- advise about and watch over Belgian identified organisms.

Contact :

Frédérique Meulders

Federal Agency for Medicines and Health Products 
Health Products Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Tel. : +32 (0)2 524 83 22
Fax : +32 (0)2 524 81 20

Email : meddev@afmps.be