26 May 2020, the date of application of the Medical Devices Regulation (MDR) is seven months away at the date of this seminar. Yet, the MDR regulatory system is still not finished (implementing acts and guidance), essential infrastructure is still not on line (Eudamed) and conformity assessment capacity (notified bodies) is lacking. Industry and even several non-EU countries are more and more concerned about what the effect will be on the EU medical devices market. And then there is Brexit, to complicate matters even more.
This seminar will take stock of where we are with the roll-out of the MDR, what we know and what we do not know yet, what to expect and how to develop scenarios for the coming months that may make the difference between staying on the market or seeing cash flow collapse. Topics include the state of play of EU level implementation, what companies still can do and should be doing in light of the 26 May 2020 date of application as well as what the Eudamed database will look like, how to work with it and how to implement it in your organisation.