| Theme | Person responsible for regulatory compliance – PRRC |
| Target Audience | Manufacturers and Authorised representative |
| Products Concerned | MD, IVD |
| Regulatory reference |
MDR (EU) 2017/745 and IVDR (EU) 2017/746 Article 15 |
| Documents mentioned | Commission Recommendation 2003/361/ΕC of 6 May 2003 |
This document provides details on the person responsible for regulatory compliance (PRRC), which must be available to the manufacturer and the authorized representative. In particular, it contains 2 important clarifications, which complement the Regulations
- The location and identity of the PRRC: If the manufacturer is based in the EU, the PRRC must also be based in the EU. If the manufacturer is based outside of the EU, the PRRC must be based outside of the EU. Since the Authorized Representative is necessarily based in the EU, his PRRC must also be based in the EU. As a result, the PRRC cannot be the same person for a manufacturer located outside the EU and its authorized representative.
- The roles and responsibilities of the PRRC of an Authorized Representative: The Authorized Representative is responsible for ensuring that all the tasks mentioned in the mandate are fulfilled.