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.
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
For more information, please contact the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.