Person Responsible for Regulatory Compliance FAQ

Q: What is a PRRC?

A: The PRRC stands for Person Responsible for Regulatory Compliance. It is a new requirement under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The role ensures that medical device manufacturers have a qualified regulatory expert responsible for compliance.

Q: Who needs a PRRC?

A: All medical device manufacturers and authorized representatives require a PRRC to comply with Article 15 of the EU MDR/IVDR. Each legal manufacturer must appoint its own PRRC if a company has more than one legal manufacturer.

Q: Who can be a PRRC?

A: A PRRC must possess expertise in medical devices and can qualify through either a formal qualification (diploma or certificate) in relevant disciplines with one year of professional experience or four years of professional experience in regulatory affairs or quality management systems relating to medical devices.

Q: What are the responsibilities of a PRRC under the MDR?

A: The PRRC is responsible for ensuring conformity checks before device release, maintaining, and updating technical documentation and the EU declaration of conformity, compliance with post-market surveillance obligations, fulfilling reporting obligations (vigilance reporting), and issuing statements for investigational devices.

Q: What are the responsibilities of a PRRC under the IVDR?

A: The PRRC responsibilities under the IVDR are similar to the MDR, including conformity checks, technical documentation, post-market surveillance obligations, reporting obligations (vigilance reporting), and issuing statements for devices used in performance studies.

Q: Does the PRRC need to be a company employee?

A: Companies with more than 50 employees and EUR 10 million in revenue must have a compliant PRRC. Smaller companies can outsource the PRRC position to an external specialist, provided they meet certain criteria and remain accessible to the company.

Q: Where does the PRRC need to be located?

A: For a manufacturer based in the EU, the PRRC must also be in the EU. For manufacturers outside the EU, the PRRC must be located outside the EU, but there must be a continuous link between the PRRC and manufacturing activities.

Q: What are the liability implications for the PRRC?

A: The liability implications for the PRRC are still unclear. The MDR/IVDR do not explicitly mention the PRRC’s liability, and national legislation may be used to explain some features until an EU-wide rule is in place.

Q: How can PRRC professionals be protected?

A: Non-profit organizations like TEAM-PRRC aim to represent PRRC professionals and advocate for their protection before regulatory authorities. Employment contracts can also include details such as limitation of liability to ensure PRRCs are not penalized for fulfilling their obligations.

Q: Why is the PRRC role essential for manufacturers?

A: The PRRC role is vital for ensuring compliance with EU MDR and IVDR regulations, maintaining the quality and safety of medical devices, and meeting post-market surveillance obligations. Having a qualified PRRC helps manufacturers navigate the complex regulatory landscape and ensures a smooth approval and certification process.