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Reviewed guidance topic

Person responsible for regulatory compliance (PRRC)

Qualifications and responsibilities of the PRRC.

Official catalogue · non-binding

Person responsible for regulatory compliance (PRRC) guidance (1)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2019-7 - rev.1Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)December 2023