Why do I need a PRRC?
It's a legal requirement laid down in MDR and IVDR. Medical device and IVD companies operating in the EU are mandated to have a PRRC within their organization. Small and micro manufacturers may not necessarily have a PRRC within their organization but must ensure the availability of such an individual permanently and continuously. Authorized Representatives (AR) are also required to have a PRRC available permanently and continuously. The PRRC must possess appropriate expertise and qualifications in the field of medical devices or IVDs, as applicable.
What my PRRC should be like?
Articles 15 of the MDR and IVDR outline the necessary qualifications and professional experience expected of a PRRC. These include:
- Attainment of a diploma, certificate, or equivalent evidence of formal qualification, granted upon completion of a university degree or a recognized course of study in law, medicine, pharmacy, engineering, or another relevant science, along with a minimum of one year of professional experience in regulatory affairs or quality management systems pertaining to medical devices.
OR
- Accumulation of four years of professional experience in regulatory affairs or quality management systems concerning medical devices and compliance with EU regulations in the field.
Any qualifications acquired outside the EU, including university diplomas or certificates, must be recognized by an EU Member State as equivalent to their EU counterparts.
Who is responsible for appointing a PRRC?
Manufacturers
Manufacturers are required to have at least one PRRC within their organization with appropriate expertise in the field of medical devices in the EU. This requirement applies when the organization has a workforce of at least 50 employees. The PRRC appointed by large manufacturers should be an employee of the company.
Assembler of systems and procedure packs
Companies that assemble devices into systems or procedure packs using devices without the CE marking, or where sterilization is not performed according to protocols, or where the combination of devices is not demonstrated to be compatible, are considered manufacturers of medical devices and must appoint a PRRC.
Authorized representatives
Authorized representatives must have a PRRC permanently and continuously available who possesses the necessary expertise.
Where should the PRRC be located?
Maintaining close proximity between the manufacturer and the PRRC is a requirement. Consequently, it is presumed that for a manufacturer situated outside the EU, the PRRC will also be located outside the EU, and for a manufacturer within the EU, the PRRC will be situated within the EU. Additionally, for micro and small manufacturers operating within the EU, the PRRC should be permanently and continuously available at their disposal, necessitating the PRRC to be located within the EU. Given that the authorized representative is based within the EU, it is assumed that the PRRC should be continuously available to them and therefore should also be located within the EU.
What role does the PRRC play?
In accordance with the MDR or IVDR, the primary responsibilities of a PRRC include ensuring that:
- Device conformity is verified and aligns with the Quality Management System (QMS).
- Technical documentation and the Declaration of Conformity are consistently kept up-to-date.
- Post-market surveillance obligations are met.
- Reporting requirements are fulfilled.
It's important to note that the PRRC is not tasked with directly performing all these functions, but rather ensuring that the company's personnel carry out these tasks effectively.
Is it possible for a company to appoint multiple PRRCs?
Yes, companies have the flexibility to appoint more than one PRRC, allowing for the division of responsibilities among them, provided that each PRRC meets the qualification requirements and that the allocation of responsibilities is clearly documented in writing.
Can an individual serve as the PRRC for both a manufacturer and its authorized representative?
No, the same individual cannot act as the PRRC for both an authorized representative and a manufacturer based outside the EU. The regulations stipulate that the PRRC serves as an additional level of scrutiny. Therefore, if one person were to fulfill both roles, it would compromise the additional level of scrutiny required by the authorized representative.
