What Is The Role of The PRRC -The Person Responsible for Regulatory Compliance?
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 o
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
What are the responsibilities of the Person Responsible for Regulatory Compliance?
- 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