Regulatory background on PRRC requirements
The designation of a Person Responsible for Regulatory Compliance (PRRC) in most EU Member States is a new requirement under Article 15 of the European Union’s Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). The PRRC is responsible for ensuring that the manufacturer and the EU Authorized Representative (EU REP) maintain conformity with MDR and IVDR requirements throughout the complete device life cycle.
All manufacturers placing devices on the EU market, including those based outside the EU, must employ a PRRC within their organization (detailed information on these topics are addressed in MDCG 2019-07 Rev.1); however, the regulations allow for small- and medium-size manufacturers to outsource this function. PRRCs must be qualified and meet specific qualifications addressed in MDR/IVDR Article 15 to perform the tasks and duties related to this role.
Responsibilities of the PRRC
As the job title implies, the PRRC’s primary responsibility is to make sure the manufacturer maintains compliance with all MDR or IVDR requirements before the device is placed on the market and throughout the device life cycle. This includes verifying the following obligations and activities are fulfilled:
- A quality management system (QMS) appropriate for the device type and risk class is maintained and kept up to date.
- Technical Documentation and the EU Declaration of Conformity are correctly prepared and maintained.
- Post-market obligations are carried out in accordance with Article 83.
- Incident reporting and field safety corrective actions (FSCAs) are conducted in accordance with Article 87.
It is important to define PRRC activities clearly in the Quality Manual or related QMS procedures and explain how these are done. For example, how will the Technical Documentation be kept current, controlled by the PRRC, and verified to an auditor? As stated in MDCG 2019-07 Rev.1:
”[T]he PRRC [...] is expected to ensure that devices for release by the manufacturer have followed procedures established in its quality management system before being placed on the market. The PRRC may carry out this activity for example, by means of auditing or sampling[.]”
"Control” of the Technical Documentation does not necessarily require the release of every produced batch through the PRRC (this may be done solely by the head of production). However, including the PRRC in the final release process demonstrates the PRRC’s involvement in production activities and how the PRRC verifies that the final Technical Documentation is correctly prepared and maintained. Whatever process you choose to verify PRRC activities, it will require an update of your QMS procedures to define the changed responsibilities and description of the involvement of the PRRC.
Mandatory qualifications of a PRRC
The MDR and IVDR require all PRRCs to meet these minimum qualifications:
A degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline and at least one year of professional experience in regulatory affairs or quality management systems related to medical devices or IVDs;
or
at least four years of professional experience in regulatory affairs or quality management related to medical devices or IVDs.
Even if your PRRC meets these qualifications, it is important to verify and document that any PRRC candidate has deep familiarity with the MDR or IVDR, as well as post-market surveillance activities and reporting requirements. It is helpful to keep records for verification of these activities as part of the Technical Documentation or at least on file in case manufacturers are audited (unannounced or announced).
