MDR at a New Standstill: COVID-19 Distancing Defers Certification Audits

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ARTICLE SUMMARY:

The one-year postponement of the European Medical Device Regulation is being whittled away by travel and social distancing restrictions and the EU’s current refusal to allow remote audits for initial MDR certifications. Industry is pushing for greater acceptance of virtual visits as a necessity in this time.

Device firms face a catch-22 in Europe—they have been given an extra year to get ready for the Medical Device Regulation, but, since that postponement was handed down in April, it has not been possible for a company to complete the MDR certification process. The reason for both the MDR delay and the current inability for companies to take advantage of the extra time is the same: COVID-19.

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