1st revision of the guidance MDCG 2019-07 on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) regarding the ‘person responsible for regulatory compliance’ (PRRC)

The Medical Device Coordination Group (MDCG) has made several additions throughout the MDCG 2019-7 guidance, including on the qualifications, professional experience, roles, and responsibilities of the PRRC, as well as references to ‘in vitro diagnostic medical devices’ document.

DOWNLOAD THE GUIDE MDCG 2019-7 Rev.1