MDCG releases guidance on Person Responsible for Regulatory Compliance

On July 1st 2019, a MDCG guidance has been published to better clarify the role of PRRC.

The main clarifications focused on qualification of the PRRC, that should always be a Manufacturer’s employee (if the Manufacturer employs more than 50 persons and if its annual turnover/annual balance sheet total exceeds 10 million Euros, as specified in this Commission Recommendation).

PRRC should possess professional experience in regulatory affairs or in quality management systems relating to medical devices . . .


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