Sterilizers

Sterilisers : any physical or moral person who sterilises in order to market systems or kits aimed at § 2 of article 7 of the Royal Decree dated 18/03/1999 (French version) or other devices with a CE marking designed by their manufacturer to be sterilised before being used.

These manufacturers must make themselves known by means of the notification form (XLS, 35 Kb) and contact beforehand a notified body in accordance with article 7 of the Royal Decree dated 18/03/1999 (French version) .

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