PRRCÂ
Medical Device Regulation – MDR (EU 2017/745) and In Vitro Diagnostic Regulation – IVDR (EU 2017/746) require companies to have a Person Responsible for Regulatory Compliance (PRRC) at their permanent disposal, if not employed. A PRRC is a regulatory expert whose responsibility is to ensure that the company is meeting applicable medical device requirements in the EU and must have the required level of qualifications and experience.
JReg Consultancy Ltd’s highly qualified consultants offer a PRRC service in accordance with EU Medical Device Regulations for manufacturers and Authorised Representatives.
