This revised article concentrates on 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.
Understanding the Role of The PRRC
Article 15 of MDR 2017/745 explicitly details the responsibilities of the PRRC. It stipulates 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.”
Similarly, Authorised representatives are required to have “permanently and continuously at their disposal at least one person responsible for regulatory compliance.” (Ref. Article 15 Person responsible for regulatory compliance (6)) . Article 15, section 6 outlines the requisite expertise which include:
- 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
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
Responsibilities of the Person Responsible for Regulatory Compliance
- Confirming that the device conforms to the manufacturers quality system prior to release
- Ensuring that the technical documentation and EU declaration of conformity are properly maintained
- Ensuring that the post-market surveillance obligations are complied with including post market surveillance plan, post-market report and periodic safety update report as applicable
- Ensuring that the reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting
- Confirming the statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices
The Provision to Outsource PRRC
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.
Commission Recommendation 2003/361/EC defines micro and small enterprises:
- 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.
Managing the PRRC
Has your organisation considered how you will manage the role of the Person Responsible for Regulatory Compliance?
Are you a small or micro-enterprise looking to appoint someone external to your organisation to fulfil this role?
Our medical device regulatory affairs experts are now assisting medical device companies of all sizes with their MDR readiness.
If you would like to talk to us today or if you would like us to act as your PRRC, call us on 00353 52 61 76 706 or complete the form on our Contact Us page.
