PRRC Obligations -Clause 15° of MDR and IVDR

All medical device manufacturers and EU authorised representatives must have appointed at least one Person Responsible for Regulatory Compliance (PRRC), with the required expertise and qualifications. If you are not familiar with the PRRC role or have doubts about the related requirements, read on

Article 15 in both the EU MDR (Regulation (EU) 2017/745 on medical devices) and the IVDR (Regulation (EU) 2017/746 on in-vitro diagnostic devices) requires manufacturers and, for manufacturers based outside of the EEA, their EU authorised representatives to have at least one PRRC in their organization.

Guidance document MDCG 2019-7 explains that the role of the PRRC adds an additional level of scrutiny and ensures that the mandatory activities related to the supervision and control of the manufacturing and post-market surveillance and vigilances are carried out appropriately. To achieve this additional level effectively, a same person cannot endorse the role of PRRC for a manufacturer located outside the EU as well as for the manufacturer’s EU authorised representative.