Dossier content

Notification is made by using a form (investigation). Be careful, a new application form has to be used.

3 copies of the investigation file must be sent as appendices to the completed form. A fee also has to be paid.

The fee for medical device is Euros 2333.84 and for active implantable medical device the fee is Euros 2443.61.

The submitted file must include the following items:

- data enabling one to identify the equipment  (description, instructions for use, brochure of the investigator…) ;

- the programme of investigation, indicating in particular the objective, the technical and scientific justifications, the scope of the study and the number of items of devices ;

- the opinion of the Ethical Committee and the aspects considered in that opinion ;

- the name of the doctor or qualified person conducting the study ;

- the place and probable duration of the study ;

- the declaration showing that the device meets the essential requirements except for those aspects covered by the clinical study, and showing that, concerning those aspects, every precaution has been taken to protect the health and safety of the patients.

- the document for patient consent. This document must be written in the language of the patients (French, Dutch or German).

-it would be appreciated if you could send a CD-ROM of the file.

The notification form and the 3 copies of the file must be sent to the following address :  

Federal Agency for Medicines and Health Products  
R&D Division 
Eurostation bloc II, 8th floor
Place Victor Horta, 40 box 40
1060 Brussel

Contact :

Federal Agency for Medicines and Health Products 
R&D Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Email : ct.rd@afmps.be

Last updated on 08/05/2017