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The Person Responsible for Regulatory Compliance (PRRC) is a position that was introduced with the MDR and should not be confused with quality assurance managers, directors, or quality management representatives. However, they can still be assigned as PRRC if they hold the required qualifications.
The qualifications of PRRC are regulated by the MDR and provide two options: a university diploma in law, medicine, pharmacy, engineering, or another relevant scientific discipline, and a year of professional experience in medical device quality assurance and quality management; or just four years of professional experience in medical device quality assurance and quality management.
Even though there can be more than one PRRC, their combined responsibilities should at least cover the control of the suitability of the product release process with the QMS, control of suitability of post-market surveillance and vigilance activities, and control of the suitability of technical documentation and Declaration of Conformity with the MDR. These responsibilities must be documented with job descriptions, organizational flow charts, and procedures, as PRRC-related processes must be implemented into the QMS.
The responsibilities of the PRRC naturally come with liability. However, the potential liabilities of the PRRC are not clearly addressed in the MDR, which creates some uncertainties regarding personal liabilities. Therefore, negligence of the PRRC’s responsibilities can be subjected to national civil, criminal, and labor laws.
The PRRC requirement will enforce organizations to have at least one regulatory expert who will be responsible for the very critical process, which will naturally increase the safety of medical devices in the market.