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Industry Outlook & Insights
Special Program
International
Regulatory, Quality and Good Manufacturing Practices
Erik Vollebregt
Partner
Axon Lawyers
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 as implementing acts, harmonized standards and guidance have not been issued, 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 hands on practical workshop 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, the economic operator regime and its influence on the company's supply chain as well as what medical devices companies still can do and should be doing in light of the 26 May 2020 date of application in order to minimize disruption of market access.
