1. Submission
Pre-submission
The notified body (NB) must announce their request for a consultation procedure by sending a Letter of intent to submit (LIS) in writing. This announcement should preferably be made electronically, at least six months before the formal submission and must be addressed to the FAMHP's National Innovation Office and Scientific-Technical Advice unit (sta.meddev@fagg-afmps.be).
Ideally, the LIS should be accompanied by the documents set out in the guidance document corresponding to the consultation procedure (see Regulations).
If necessary, for example when large electronic files (≥ 10 MB) need to be submitted, electronic consultation requests can also be submitted via EudraLink or sent on a USB stick to:
Federal Agency for Medicines and Health Products
Directorate-General PRE authorisation
National Innovation Office and Scientific-Technical Advice Unit
Avenue Galilée 5/03
1210 BRUSSELS
Belgium
The FAMHP strongly recommends a pre-submission meeting with the NB concerned and the medical device manufacturer. This meeting should ideally take place at least two months before the planned date for the formal submission of the consultation request. The aim of the meeting is to help the notified body and the device manufacturer to prepare their formal consultation request.
Submission
The formal consultation request should be submitted via the corresponding application form:
- Application form – Drug-device combinations
- Application form – Tissues or cells
- Application form – Absorbed or dispersed
- Application form – Companion diagnostics
A single electronic copy of the documentation should be provided via EudraLink or email (see above). References to published literature should be accompanied by the full text of the article/study published.
Detailed information on the documentation required to support an advice request can be found in the corresponding guidance document (see Regulations).
Once a formal consultation request has been submitted, the FAMHP will normally not accept any additional details or amendments to the consultation file, unless these have been requested by the FAMHP or agreed at the meeting prior to the submission of the request with the NB and the device manufacturer.
2. Payment of fees
- Please find the applicable rates for consultation procedures with NBs at STA fees
For more information, you can consult the Fees page.
3. Procedure
All consultation requests are submitted for a validation stage to verify whether the request complies with all the requirements set out in paragraph 1.
Following the formal validation, consultation requests are processed by the FAMHP in writing and the final scientific advice will by default be communicated to the NB within the following deadlines, in accordance with Regulation (EU) 2017/745 of 5 April 2017 on medical devices and Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices.
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Advice request concerning a medical device incorporating a medicinal substance as an accessory (see MDR Annex IX, Section 5.2)
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210 days |
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Advice request concerning devices manufactured utilising or incorporating issues or cells of human origin or their derivatives, that are non-viable or are rendered non-viable (see MDR Annex IX, Section 5.3.1)
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120 days |
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Advice request concerning devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body (see MDR Annex IX, Section 5.4) |
150 days |
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Advice request concerning the assessment of the technical documentation of companion diagnostics (see IVDR Annex IX, Section 5.2)
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60 days |
More detailed information, including the legal scope of the request, procedures and deadlines, can be found in the guidance documents (see Regulations).
4. Notifications by the notified body
At the end of the consultation procedure, the NB sends its final decision to the FAMHP. The NB shall duly take into account the advice expressed during the consultation with the FAMHP in making this decision. In accordance with Regulation (EU) 2017/745, Annex IX, Section 5.2, paragraphs (e) and (f), and Section 5.3.1, paragraphs (c) and (d), the NB shall not issue the certificate if it has received unfavourable advice from the FAMHP and the NB is expected to send its final decision to the FAMHP. In all other cases, the NB is requested to inform the FAMHP before issuing the certificate if the NB is not in favour of following some of the FAMHP's scientific advice shared during the consultation.
If the NB requests a new consultation with a competent authority other than the FAMHP after the FAMHP has shared its advice, the FAMHP must be informed of the result of this consultation. Furthermore, the NB may withdraw its request from the FAMHP during the consultation and may request a consultation with another competent authority, in which case it must inform the FAMHP.