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Person Responsible for Regulatory Compliance
Named individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026
Definition
PRRCs must possess defined qualifications and experience and are personally responsible for conformity checks, technical documentation maintenance, post-market surveillance, vigilance, and clinical investigation reporting. Under MDR and IVDR Article 15, the PRRC must have documented expertise, through a relevant degree plus at least one year of regulatory or quality experience, or four years of experience. They are responsible for checking conformity before release, technical documentation, post-market surveillance, vigilance reporting and investigational device statements. Micro and small enterprises may use an external PRRC who is permanently available. What the regulation says
The EU Medical Device Regulation (MDR) 2017/745, specifically Article 15, mandates the appointment of a Person Responsible for Regulatory Compliance (PRRC) for manufacturers and authorized representatives. This individual ensures compliance with the regulation, overseeing aspects like conformity assessment procedures, technical documentation, and post-market surveillance. Similarly, the EU In Vitro Diagnostic Regulation (IVDR) 2017/746 also includes provisions for a PRRC, mirroring the MDR requirements.What this means in practice
Small manufacturers can engage an external PRRC; importers and authorized representatives also have PRRC obligations under specific conditions.Examples
- A medical device manufacturer appoints an internal employee with a master’s degree in biomedical engineering and two years of experience in quality assurance as their PRRC, documenting their qualifications and responsibilities in the quality management system.
- A small start-up company developing an innovative diagnostic software engages an external consulting firm to provide PRRC services, ensuring that the consultant meets the experience and qualification criteria outlined in EU MDR Article 15.
- During an audit, an notified body reviews the PRRC’s job description, curriculum vitae, and evidence of continuous professional development to verify compliance with regulatory requirements.
Common pitfalls
- •A common pitfall is misunderstanding that the PRRC’s personal liability extends to criminal charges in certain jurisdictions for non-compliance.
- •Companies often fail to adequately define the PRRC’s direct access to management and resources, hindering their effectiveness.
- •Organizations may mistakenly believe that appointing an external PRRC absolves them of their own regulatory compliance responsibilities.
- •Inadequate documentation of the PRRC’s qualifications and experience can lead to non-conformities during audits.
- •Manufacturers sometimes neglect to update the PRRC’s responsibilities and training as regulations evolve or product portfolios change, leading to compliance gaps.
Frequently asked questions
The primary role of a PRRC is to ensure that medical devices consistently meet the requirements of the EU MDR, covering areas such as conformity assessment, technical documentation, and post-market obligations.
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 2Regulator guidance and consensus· 2Tier 4Trade press and expert commentary· 1
Link health: 3 verified· last checked 2026-06-20
MDCG·1RAPS·1FDA·1
- 1MDCG 2019-7 PRRCTier 2 VerifiedMDCGhealth.ec.europa.eu
- 2RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
- 3FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
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