September 7, 2020

The Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) Mandate that Device Manufacturers Have a Person Responsible for Regulatory Compliance (PRRC): Guidelines and Support

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.  

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