What is Person Responsible for Regulatory Compliance PRRC ?

PRRC stands for Person Responsible for Regulatory Compliance. It is one of the requirements of the European Union’s Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). It intends to ensure that your company has a qualified regulatory expert at your disposal.

With this, European regulator aim to ensure you have a EU regulatory expert allocated to make sure that your company is meeting certain specific EU requirements.