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Person Responsible for Regulatory Compliance - PRRC

We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.

PRRC – Person Responsible for Regulatory Compliance

MDR introduces a new role – Person Responsible for Regulatory Compliance or PRRC.
The primary responsibilities of PRRC are those mentioned in Article 15 of the EU MDR 2017/745 and IVDR 2017/746 and include ensuring:

  • Conformity of the product device to the Medical Device Regulation and
  • Quality Management System
  • Conformity of the Technical Documentation and EU Declaration of conformity
  • Compliance with Post-Market Surveillance (PMS) following Article 10(10)
  • Compliance with the Vigilance Reporting obligations (Article 87 to 91)

See also MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC).

BioReg Experts could provide full PRRC service to your company.

PRRC could be a full-time employee or an external consultant, permanently and continuously at the disposal to Micro and Small enterprises.
The required education and work experience for the PRRC include the following:

  • Diploma in law, medicine, pharmacy, engineering, or another scientific discipline and one year of experience in Regulatory Affairs or Quality Management Systems on medical devices or
  • Four years of experience in Regulatory Affairs or Quality Management Systems on medical devices

Our firm provides EU MDR & IVDR Consulting for medical devices of all types.

  • Medical device classification
  • Verification of applicable standards and testing requirements
  • Writing MDR or IVDR Technical Documentation or review
  • Review of Labeling & UDI
  • Verification of compliance with General Safety and Performance Requirements (GSPR)
  • Writing Post Market Surveillance (PMS) Plan & Reports (including PDUR)
  • Writing Post Market Clinical Follow-up (PMCF) Plan & Report
  • Writing Literature Search Plan (Protocol) & Report
  • Writing Clinical Evaluation Plan & Report
  • EUDAMED Actors and Products registration
  • Building and maintenance of a Quality Management system (ISO 13485)
  • Risk assessment and management (ISO 14971:2019) Plan & Report
  • Development of Risk, Clinical Evaluation, Vigilance, and PMS procedures

See more about our EU MDR & IVDR services

For more information, please get in touch with the BioReg team.

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In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

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