Tailor-made medical devices
« Tailor-made devices » : any device that is specifically manufactured according to the written instructions of a suitably qualified practitioner indicating, under his responsibility, the specific characteristics of the design and if it is intended only for being used on one particular patient. The manufacturer of such devices must notify that they are marketing the devices by means of a notification form (article 10 of the Royal Decree dated 18/03/1999 (French version) ).
Dental devices manufactured by dental technicians according to instructions by dentists clearly fall within the definition of tailor-made medical devices. Additional information can be found in circular 405 .The notification form must be completed taking into account the check-list and returned together with the required documents :
- List of manufactured products
- Model of declaration of conformity
- Proof of payment of the fee
- Copy of the legal statute (copy of the “Moniteur” or the registration at the “Registre de Commerce”)
Additional information can be found under guidelines for dental technicians .
Federal Agency for Medicines and Health Products
Health Products Division
Place Victor Horta, 40 box 40
Fax : +32 (0)2 524 81 20
Email : firstname.lastname@example.org