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.