Author: Suzanne Broussard | September 07, 2020
The newly created Person Responsible for Regulatory Compliance (PRRC) position is a unique regulatory requirement that applies only to the European Union, and is a key area of responsibility for a person or persons under the Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR).
The motivation for creating the PRRC positions is so that there is a qualified regulatory expert directly responsible for the manufacturing and the market surveillance and reporting systems to ensure the company is meeting the European Union requirements.
The Regulations have a clear desire to add an additional level of scrutiny to the supervision and control of the manufacturing of medical devices, as well as relevant post-market surveillance and vigilance activities. Thus, the PRRC role is purposefully a unique position from the European Union Authorized Representative.