MedTech Terms
    The authoritative reference
    All terms

    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 May 5, 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.

    What this means in practice

    Small manufacturers can engage an external PRRC; importers and authorized representatives also have PRRC obligations under specific conditions.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    MDCG·1RAPS·1FDA·1
    1. 1
      MDCG 2019-7 PRRC
      Verified
      MDCGhealth.ec.europa.eu
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.