The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices.
Article 15 of MDR 2017/745 sets out the detail of the person responsible for regulatory compliance. It requires that manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. Similar authorised representatives are required to have permanently and continuously at their disposal at least one person responsible for regulatory compliance. The requisite expertise is also detailed in Article 15 and involves either:
- a formal qualification such as a degree in law, medicine, pharmacy, engineering or other relevant scientific discipline and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices or
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
The five main responsibilities of the person responsible for regulatory compliance are to ensure that:
- The device conforms to the manufacturers quality system prior to release
- The technical documentation and EU declaration of conformity are properly maintained
- The post-market surveillance obligations are complied with including post market surveillance plan, post-market report and periodic safety update report as applicable
- The reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting
- The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices
There is a provision within MDR that allows micro and small enterprises to outsource the PRRC role and to have an appropriately qualified person permanently and continuously at their disposal rather than having that person within their organisation. The definition of micro and small enterprises comes from Commission Recommendation 2003/361/EC and relates to number of employees and turnover/balance sheet figures. A small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million. A micro enterprise is defined as an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million. The outsourced PRRC must then be listed as a critical supplier on the manufacturers quality system and an agreement must be in place between both parties.
Has your organisation considered how you will manage the role of person responsible for regulatory compliance? Are you a small or micro enterprise looking to appoint someone external to your organisation to fulfil this role? Acorn Regulatory’s team of experts are now assisting medical device companies of all sizes with their MDR readiness. If you would like to talk to us today about how we might be able to assist you with getting ready for the MDR or if you would like us to act as your PRRC, then please do contact us today. Call us on 00353 52 61 76 706 or complete the webform below.