Chair of the Board of Trustees Global Medical Devices Nomenclature
The essence of being is to learn as you move along. So, what have we learned from MDR implementation sofar? What is clear, and where is more clarity needed. Is there anything new ahead, additional legislation, guidance documents etc. And how are we dealing with the complexities of the EUDAMED delay, and with the MDR sections on economic operators and PMS that kick in on 26 May 2020 for all products, including legacy products under MDD/AIMD grace period. The panel will bring several key opinion leaders from various stakeholders to bring the latest interpretations fresh from Brussels. An interactive session to look forward to!
Interpret key elements of EU MDR and EU IVDR.
Describe the latest development in EU regulatory landscape.
Modify MDR / IVDR transition schemes to the latest knowledge on notified body and regulator processes and expectations.