During the development of certain medical devices and in vitro diagnostic medical devices (IVDs), notified bodies (NBs) are required to seek a scientific opinion from a national competent authority (NCA) in order to issue an EU technical documentation assessment certificate for a product. The FAMHP’s directorate general (DG) PRE authorisation offers notified bodies the option to consult the FAMHP as the national competent authority.
For this purpose the National Innovation Office and Scientific-Technical Advice unit of the DG PRE authorisation offers a centralised and transparent service within the FAMHP which should ensure the processing of consultation requests in a timely fashion while assuring full confidentiality and potential conflict of interest of the involved experts.
Any general or specific inquiries regarding the FAMHP's "Consultation procedure by a notified body" can be sent to the email address sta.meddev@fagg-afmps.be.
However, applicants are invited to consult the guidance documents (see Regulations), before sending any questions to the above-mentioned email address.
1. Consultation procedures
The general objective of the consultation procedures with notified bodies, as stipulated in Annex IX of Regulation (EU) 2017/745 of 5 April 2017 on medical devices and in Annex IX of Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices, is to verify the safety and quality of medicinal substances and/or health products used in combination with medical devices or in IVDs or of the compounds of the medical device that are absorbed or locally dispersed in the human body. In this context, the FAMHP guarantees the following procedures:
- consultation procedure for a notified body concerning a medical device incorporating a medicinal substance as an accessory (notice referred to in Annex IX, Section 5.2 of Regulation 2017/745);
- consultation procedure for a notified body concerning devices manufactured using or incorporating tissues or cells of human origin, or their derivatives, which are non-viable or are rendered non-viable (notice referred to in Annex IX, Section 5.3.1 of Regulation 2017/745);
- consultation procedure for a notified body concerning devices composed of substances or combinations of substances that are absorbed or locally dispersed in the human body (notice referred to in Annex IX, Section 5.4 of Regulation 2017/745);
- consultation procedure for a notified body concerning the assessment of the technical documentation of companion diagnostics (notice referred to in Annex IX, Section 5.2 of Regulation 2017/746).