EU Regulation 2017/745 on medical devices (MD Regulation, MDR) is nearing the end of its transitional period. The Europe-wide application of the MD Regulation will begin on 26 May 2021. One of the most significant new regulatory provisions is related to the increased requirements for internal monitoring by companies, namely the designation of a Person Responsible for Regulatory Compliance (PRRC). Below, we provide brief answers to some key questions pertaining to the PRRC requirements:
What kinds of companies are required to have a designated PRRC?
All manufacturers of medical devices or IVD devices are required to have a PRRC either within their organisation or otherwise continuously at their disposal.
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 an expert’s educational qualifications and expertise relating to medical devices. If you are uncertain about the exact interpretation of these criteria and where to draw the line, you should consult a regulatory specialist.
What are the responsibilities of a PRRC?
Article 15(3) of the MDR sets out five key responsibilities for PRRCs. In sum, the key task of a PRRC is to ensure regulatory compliance in a company. PRRCs are advised to carefully familiarise themselves with their responsibilities as set out in the Regulation.
By when do manufacturers need to designate a PRRC?
For manufacturers of medical devices, the deadline for designating a PRRC is 26 May 2021. For manufacturers of in vitro diagnostic medical devices, the requirements are the same, but they will enter into force exactly one year later, on 26 May 2022. Companies are required to submit information on their PRRC to the Eudamed database.
What kinds of companies have the option of designating a PRRC outside their organisation?
As a rule, manufacturers are required to have a PRRC within their organisation. As an exemption, the EU has given micro and small enterprises the option to outsource their PRRC expert services, but 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.
DRA has comprehensive expertise in the new MD Regulation as well as the requirements and qualifications of PRRCs. We are happy to advise you on matters related to the Regulation and you can also find a small enterprise’s PRRC through us if necessary. Please don’t hesitate to contact us!
Tel: +358 9 825 64 217