PRRC

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.