Content tagged with CER

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By when do I need to update the Clinical Evaluation Report?

By when do I need to update the Clinical Evaluation Report?


KPMG, RAPS survey finds many device makers ill-prepared for 2020’s EU MDR

An industry survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found little familiarity with the European Union’s new Medical Device Regulation and its requirements that take full effect in May 2020.