PRRC stands for ‘Person Responsible for Regulatory Compliance’. This is a new mandatory role required by EU Regulations 2017/745 on medical devices (MD Regulation, MDR) and 2017/746 on In vitro diagnostic medical devices (IVD Regulation, IVDR) from medical device manufacturers and authorized representatives.
What kind of companies are required to have a designated PRRC?
Medical device or IVD device manufacturers and authorized representatives are required to have a PRRC within their organization.
Can PRRC be outsourced by the organization?
As a rule, manufacturers are required to have a PRRC within their organization. As an exemption, the EU has given micro and small enterprises the option to outsource their PRRC. The external party is required to ensure that the PRRC is permanently and continuously at the company’s disposal. A small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover does not exceed EUR 10 million.
Can anyone serve as a PRRC?
No. The criteria for a PRRC’s expertise are clearly defined in the Regulation. Article 15 sets out requirements for a PRRC’s educational qualifications and expertise relating to medical devices.
What are the responsibilities of a PRRC?
Article 15(3) of the MDR sets out five key responsibilities for PRRCs. As a summary, the key task of a PRRC is to ensure regulatory compliance in the company. PRRCs are advised to carefully familiarize themselves with their responsibilities as set out in the Regulation.
If you are uncertain about the exact interpretation of these criteria and where to draw the line, please contact our MDS team at PharmaLex Nordics. We provide high quality PRRC services to small and micro sized companies.