7 October 2020 - A short conversation with the European Commission provides details on when we can expect access to their expert panels.
The European Union's Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") require the establishment of expert panels to provide stricter control for high-risk devices. The European Commission expert panels have the following tasks, depending on needs, as summarized on their website here and provided below:
- "providing an opinion on the notified bodies’ assessments of clinical evaluation of certain high-risk medical devices and the performance evaluation of certain in vitro diagnostic medical devices
- providing advice to the Medical Device Coordination Group (MDCG) and the European Commission concerning safety and performance of medical devices and in vitro diagnostic medical devices
- providing advice to manufacturers on their clinical development strategy and proposals for clinical investigations
- providing advice to EU countries, manufacturers and notified bodies on various scientific and technical matters
- contributing to the development and maintenance of relevant guidance documents, common specifications and international standards
- providing opinions in response to consultations from manufacturers, EU countries and notified bodies"
The European Commission provides a Secretariat for the expert panels to support the efficient functioning of the expert panels, with the following mailbox: SANTE-EXPAMED@ec.europa.eu
Recently, Nancy Morrison, R&Q's Executive Regulatory Director, reached out to the Secretariat with the following question:
R&Q has a client that manufactures a class III device and is interested in gaining an opinion of the expert panel before conducting their clinical trials consistent with EU MDR 2017/745 Article 61(2):
2. For all class III devices and for the class IIb devices referred to in point (b) of Article 54(1), the manufacturer may, prior to its clinical evaluation and/or investigation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer's intended clinical development strategy and proposals for clinical investigation. The manufacturer shall give due consideration to the views expressed by the expert panel. Such consideration shall be documented in the clinical evaluation report referred to in paragraph 12 of this Article.
Could you please advise when this process will be available and provide guidance on how to initiate such a consultation?
She was pleased to have received the following response within three days:
"Thank you for your question.
I am afraid that the service foreseen under Article 61(2) will not be available for the moment, that is for the next 2 years. We are focusing now on setting-up the panels and making available the mandatory functions of the panels, which are the Clinical Evaluation Consultation Procedure and the Performance Evaluation Consultation Procedure.
When available, the service will be announced on the site of the panels.
Scientific Policy Officer"
Ibim Tariah, R&Q's Vice President of EU MDR and IVDR Consulting Services and former BSI Technical Director of Medical Devices, provided this interpretation of the EC response:
“It should still be possible to seek “Scientific Advice” from a Competent Authority, if necessary. I do not believe the intent by the EU authorities is to ‘pause’ device innovation until the expert panels are ready. Until expert panels become operational, seeking scientific advice from a Competent Authority is a pragmatic pathway forward.”
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