Guidance on Person Responsible for Regulatory Compliance

The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the “Person Responsible for Regulatory Compliance” (PRRC) according to article 15 of the MDR and IVDR. There are no big surprises, but it still answers some questions that are not directly answered in the corresponding Regulations.

More specifically, the document clarifies that:

  • in terms of qualification evidence “any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognized by an EU Member State”, 
  • professional experience should be “related to the EU requirements in the field”,
  • the PRRC must be an employee of the company (except for small and micro manufacturers),
  • entities with several legal manufacturers must have a PRRC for each legal manufacturer,
  • an individual may not be the PRRC for  a manufacturer and its authorized representative at the same time.

There are more specifics, for example how to interpret the roles and responsibilities of the PRRC as stated in the MDR and IVDR. Please click here to download the original guidance document.

Source: MDCG guidance on the person responsible for regulatory compliance

We provide additional information and downloads on this subject:

Guidance Documents in our Complete Download Section regarding MDR
Guidance Documents in our Complete Download Section regarding IVDR

If you require further information on this topic, please don’t hesitate to get in touch with our team.