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Under Article 15 of MDR and IVDR, companies are required to have at least one employee responsible for regulatory compliance with a degree in law, medicine, pharmacy, engineering or another relevant scientific discipline and four years of relevant professional experience in quality management systems relating to medical devices.


Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC)