Devices class I

These devices belong to the class covering the lowest risk. The manufacturer must notify the launch beforehand by means of a notification form (XLS, 33 Kb) (article 10 of the Royal Decree dated 18/03/1999 (French version)) (see instructions (DOC, 47 Kb) to be followed when filling in the form) and he must make available to the authorities a full technical document showing that it conforms to the main demands  (directives relating to class I ).

Manufacturers of sterile medical devices in class I and/or with a measuring function must contact a notified body (WEB) whose involvement will only be with the measuring function and/or the sterility.

Companies outside the European Union must have an authorised representative in the EU who will proceed in notifying the Member State where he is located.

Contact :

Lida De Boeck

Federal Agency for Medicines and Health Products

MedicHealth Products Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Tel. : +32 (0)2 524 81 12
Fax : +32 (0)2 524 81 20

Email : meddev@afmps.be