Following the introduction of the Medical Device Regulation, MDR (EU) 2017/745, and In Vitro Diagnostic Regulation, IVDR (EU) 2017/746, comes a new requirement that medical device companies have a regulatory expert at their disposal. It is the responsibility of this expert, or Person Responsible for Regulatory Compliance (PRRC), to ensure the company is adhering to the requirements of the relevant regulation.
This designated person may be a suitably qualified member of the organisation or, for micro and small enterprises an external individual with the necessary qualifications that is continuously and permanently at their disposal. The necessary qualifications for this role are either:
|Option 1||A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline||At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.|
|Option 2||No formal qualifications||Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.|
The responsibilities included in the PRRC service are as follows:
- Ensuring adequate quality management system is in place and audits are regularly carried out.
- Review of the technical documentation and identification of any gaps or updates required
- Ensure EU declaration of conformity has been drawn up and is up to date
- The post-market surveillance obligations details in Article 10 of MDR 2017/745 and IVDR 2017/746 are complied with.
- Report any serious incidents to the EU competent authority in accordance with article 87 and 91 of MDR 2017/745 and IVDR 2017/746.
Patient Guard consultants have the necessary qualifications and experience to act as PRRC for our clients and are available to offer regulatory advice as part of this service. If you would like to discuss this service with us, then please contact us for more information.