PRRC | Person Responsible for Regulatory Compliance

PRRC

Person Responsible for Regulatory Compliance 

Article 15(c) of the European MDR (2017/745) and the IVDR (2017/746), requires that the manufacturer shall have a person that will be responsible for regulatory compliance (PRRC) also has the requirement and the explicit responsibility to ensure that all postmarket surveillance and obligations are met in accordance with Article 10(10). The recent June 2019 EU PRRC Guidance Document (MDCG 2019-7)4 further expands on the required education and experience the PRRC should have – with the two optional requirements being: 

• A diploma or certificate or other types of evidence of formal qualification awarded by a university in law, medicine, pharmacy, engineering or other relevant fields, plus one year experience in medical devices or quality management systems for medical devices and if this certificate or diploma is from a non-EU institution, further verification of acceptance by an EU member state in regard to equivalence to the EU qualification is required OR

• Four years of professional experience in regulatory or quality management systems for medical devices, with specific regard to European requirements/regulations.