Medical device CE marking

MDCG 2019-7 Rev.1 published on the PRRC

2023-12

MDCG 2019-07, on the Person Responsible for Regulatory Compliance (PRRC, Article 15 of the MDR/IVDR), was originally published in June 2019 and has now been revised.

There are updates on:

  • Qualifications needed to hold the role of the PRRC
  • PRRC requirements for Micro and Small Manufacturers
  • Roles and responsibilities of the PRRC of a manufacturer (Article 15(3))
  • Entities assuming the obligations of a manufacturer
  • Registration of the PRRC in EUDAMED

The guidance can be downloaded in our library

Source: European Commission