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 (article 10 of the Royal Decree dated 18/03/1999 (French version)) (see instructions 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.
The different documents can also be sent in electronic version. Please follow the instruction mentioned in the following document : archivage
Federal Agency for Medicines and Health Products
MedicHealth Products Division
Place Victor Horta, 40 box 40
Fax : +32 (0)2 524 81 20
Email : firstname.lastname@example.org