Guidance on "person responsible for regulatory compliance" (PRRC).

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 representative?


At the same time it indicates the need for further guidance on the roles and responsibilities of the PRRC that should be given in further guidance documents on post-market surveillance, vigilance, clinical investigations and performance studies, created at a European level.