Classification

Medical devices are listed according to four product categories (class I, IIa, IIb and III) according to the degree of risk when used. The classification rules are described in appendix IX of the Royal Decree dated 18th March 1999 (French version) relating to medical devices. European guidelines for classification are also available (document MEDDEV 2.4/1 part 1 and part 2).

Contact :

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

Fax : +32 (0)2 524 81 20

Email : meddev@afmps.be

Last updated on 28/02/2014