The new regulations, i.e., EU MDR (2017/745) and EU IVDR (2017/746) have made regulatory requirements for medical device manufacturers more stringent. It is now mandatory for medical device manufacturing companies to ensure that they have a qualified and competent Regulatory Expert who can help them become compliant with the new regulations. To cope with it, Article 15 of EU MDR and IVDR have introduced a new role known as Person Responsible for Regulatory Compliance (PRRC).
In June 2019, a document providing guidance on PRRC was released. This guidance document proves greater insight within the PRRC requirements. It must be noted here, however, that the role of PRRC is different from that of European Authorized Representative (E.A.R.).
Comparison between Responsibilities of EAR & PRRC
Qualifications of PRRC
According to the guidance document on PRRC, the PRRC must:
- Be proficient in the field of medical devices
- Have a formal qualification such as a university diploma or a degree
- Minimum one-year experience in European regulatory affairs or QMS concerned with medical devices
- If the PRRC does not have any university diploma, degree, or any other acceptable qualification, they must have experience of four years in either the field of QMS, European regulatory affairs, or medical devices.
Facilities Given in EU MDR for PRRC
EU MDR provides many facilities and permissions to PRRCs such as:
- Service outsourcing
- Having a mulitple or single PRRC.
Service Outsourcing
EU MDR allows micro and small enterprises to hire a PRRC on contract instead of placing him permanently within their organization.