Regulatory
Person Responsible for Regulatory Compliance(PRRC)
In one line
Named individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer.
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.
Why it matters
Small manufacturers can engage an external PRRC; importers and authorized representatives also have PRRC obligations under specific conditions.
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.
Sources
- MDCG 2019-7 PRRC · MDCG
- RAPS Regulatory Focus · RAPS
- FDA - Medical Devices · FDA