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Transition to European Medical Device Regulation – Ongoing Challenges
July 15, 2020 9:00 AM - 10:00 AM
(EDT)
Description
Join MassMEDIC and Boston MedTech Advisors for a discussion on potential opportunities and challenges to certification under the new MDR.
About this Event
Sweeping changes to the regulation of medical devices in Europe went into effect in May 2017, with a 3-year transition period from MDD to MDR. However, due to coronavirus, the transition has been extended until May 2021, giving companies more time to implement the new regulations.
In this webinar, some key issues related to the new MDR will be addressed, including:
Current status of notified body accreditation;
Clinical evaluations, clinical data, equivalence;
Changes in classification;
and Non-clinical challenges –
Authorized Representative (AR), Person Responsible for Regulatory Compliance (PRRC), Post Market Surveillance (PMS).
