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