All I can add is that the EU has implemented a bureaucratic nightmare, and the whole MDR should at most apply to Class IIb and Class III devices. My firm is pulling our Class Is device from the market because the margins don't bear the increased costs. And yes, the period between the 2017 adoption of the MDR and the Date of Application was largely meaningless, as implementation guidances were not forthcoming for the most part until 2020, and many are still lacking. Plus, there is the NB nightmare. We could blame all of this on COVID, but I don't think the EU had it in one bag to start with and hastily (don't confuse that with quick, they aren't quick with anything) foisted a stifling regulation on the industry that will be detrimental to the healthcare of the people under their dominion. Hate to say it, but at least FDA thinks things through a bit better.
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James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
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Original Message:
Sent: 26-May-2021 05:00
From: Richard Vincins
Subject: Happy EU MDR Compliance Day !
Hope you are all ahead of schedule, getting QMS reviewed happily, and Technical Documentation reviews complete ! Should be a fun few years moving through the transition grace period !
Corrected from Erik, absolutely right we are in the grace period now - good luck with legacy devices !
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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