Medical devices

The distribution of medical devices is regulated by article 10bis of the Royal Decree dated 18/03/1999 (PDF, 1.04 MB) relating to be medical devices modified by the Royal Decree dated 02/05/2005 (PDF, 99.55 Kb) and by the Royal Decree dated 18/05/2005 (PDF, 52.72 Kb). 

The distribution of medical devices in category 1 of annex X111 in the Royal Decree dated 18/03/1999 must be notified beforehand by means of ad hoc forms: notification form (MDD) (XLS, 33.5 Kb) and the list of products (MDD) (XLS, 18.5 Kb).

If the file is complete a registration number is communicated to the applicant as proof of his notification.

The list of the distributors and exporters recognised for their medical devices in category I of annex XIII of the Royal Decree dated 18/03/1999 (MDD) AR 18/03/1999. (XLS, 149.5 Kb)

Contact :

Nathalie Demaret, Eddy Buys

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 81 18 / 81 17
Fax : +32 (0)2 524 81 20

Email : meddev@afmps.be