01. July 2019

The MDCG is giving further guidance concerning the ‘person responsible for regulatory compliance’ (PRRC) The document MDCG 2019-7 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) explains several specific questions around the PRRC, such as: Can the PRRC be located outside the EU? Can one individual be the PRRC for a manufacturer and its authorised...