MDR additional authority consultation procedures 

Medical Device Regulation 2017/745 (MDR) updates the legal framework for all medical devices intended to be placed on the European Single Market. The MDR includes new or extended provisions requiring Notified Bodies to enter into additional consultation procedures with relevant competent EU authorities. The involved authorities can have a scope outside the medical devices area (e.g. pharmaceuticals, tissues and cells) or can be part of the new MDR legal framework (e.g. clinical expert panels).

This webinar provides a condensed overview of the various MDR consultation procedures and explains which medical devices will be subject to which consultation procedure. It also highlights the timelines for these consultations, as stipulated by the MDR. Advance knowledge whether your medical device falls under the scope of these consultations is valuable information for planning your market access under the MDR.

Date and time: Wednesday, 4 November 2020, 7:30 pm (CET)

Your speaker: Dr. Sabina Hoekstra, Regulatory Strategy Principal


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