Who is the Person Responsible for Regulatory Compliance (PRRC) under MDR and IVDR?

The Person Responsible for Regulatory Compliance (PRRC) is a designated expert overseeing the compliance of a medical device with MDR 2017/745 and IVDR 2017/746. According to Article 15 of both regulations, every manufacturer and EU authorised representative must appoint a PRRC. This role covers the entire product lifecycle—from design and preparation of the technical documentation to post-market surveillance.

PRRC competence requirements

The PRRC must meet the criteria set out in MDR and IVDR:

  • A degree in technical or medical disciplines and at least one year of experience in regulatory affairs or ISO 13485 quality systems,
  • or at least four years of professional experience in MDR/IVDR, QMS, or regulatory oversight.

Familiarity with ISO 14971 (risk management), clinical evaluation, and market surveillance processes is essential. In practice, documentation proving PRRC qualifications should be part of the QMS and include CVs, role descriptions, contracts, and evidence of regulatory competence per MDCG 2019-7.

PRRC-related requirements under MDR and IVDR

  • All medical device and IVD manufacturers must have a designated PRRC.
  • Micro and small enterprises may outsource PRRC responsibilities, ensuring constant availability.
  • The authorised representative must appoint their own PRRC, independent of the manufacturer.

The PRRC is also responsible for correct EUDAMED data entries related to compliance and post-market surveillance under Articles 29 and 31 of MDR and IVDR. Failure to appoint a PRRC can result in certification loss, market access denial, or administrative penalties.

Key responsibilities of the PRRC

  • Ensuring device compliance with MDR and IVDR,
  • Verifying technical documentation, declarations of conformity, and clinical evaluations,
  • Reporting incidents and FSCA actions,
  • Maintaining communication with notified bodies and competent authorities,
  • Reviewing post-market surveillance plans and reports, including adverse trend analysis.

When and how to appoint a PRRC

All manufacturers are required to appoint a PRRC:

  • Large companies must appoint an internal PRRC.
  • Micro and small enterprises may outsource, ensuring continuous availability.

The PRRC’s role must be documented in the QMS through RACI matrices, SOPs, and relevant operational instructions. Not having a PRRC is a direct violation of MDR and IVDR.

Does the EU authorised representative need their own PRRC?

Yes. Under MDR and IVDR, each EU authorised representative must designate their own PRRC. This person must be independent of the manufacturer to avoid conflicts of interest.

How Pure Clinical supports manufacturers with PRRC compliance

Pure Clinical supports medical device and IVD manufacturers by offering:

  • PRRC outsourcing services – experts compliant with MDR and IVDR,
  • Comprehensive PRRC and RA/QA team training,
  • Preparation of QMS documents confirming PRRC qualifications (CVs, contracts, role descriptions),
  • Support during notified body audits and inspections by competent authorities,
  • Development and validation of PMS and vigilance procedures, in line with MDCG 2023-3 and 2023-4.

PRRC services from Pure Clinical help manufacturers maintain compliance and avoid regulatory and operational risks.

FAQ

What are the most common mistakes companies make when appointing a PRRC?

Typical mistakes include failing to document the PRRC's qualifications properly, assigning the role to underqualified staff, or overloading the PRRC with non-regulatory tasks, which may lead to compliance failures during audits.

Can the PRRC also serve as the company’s RA/QA Manager?

Yes, provided that this dual role does not create a conflict of interest and that the individual has sufficient time and resources to fulfill their regulatory responsibilities in line with MDR and IVDR requirements.

What digital tools are available to support the PRRC’s daily responsibilities?

PRRCs often use integrated QMS platforms connected to EUDAMED, vigilance management tools, PMS/CAPA software, and document control systems like MasterControl, Veeva, or Greenlight Guru to ensure compliance and operational traceability.

What penalties can a company face for failing to appoint a qualified PRRC?

Non-compliance may result in certification denial, administrative fines, suspension of market access in the EU, or legal consequences from competent authorities, making the proper appointment of a PRRC mission-critical.