The European Commission MDCG 2019-7 provides guidance on "Persons Responsible for Regulatory Compliance’ (PRRC).
The European Commission (EC) has recently published 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).
Meeting the requirements here will be a challenge for SMEs and start-ups but the guidance offers practical assistance.
Requirements for Persons Responsible for Regulatory Compliance (PRRCs).
The prerequisite expertise for a PRRC, as set out in the new regulations, must fulfil either of the following criteria:
- a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
The MDCG Guidance offers a flexible interpretation, especially for SMEs. But every EU manufacturer and distributor needs to read it carefully to determine if the PRRC requirements will be fulfilled.
1. The Medical Device Coordination Group (MDCG) Series of Guidelines is a very useful and readily understandable set of publications, which are continuously expanding. If EU Regulatory Affairs for medical devices is of interest their website is well worth monitoring.
2. All EU Manufacturers and Authorised Representatives need to comply with PRRC requirements – don’t ignore either the regulations or the guidance.
3. In the UK (Great Britain) there is currently no requirement for a person equivalent to the PRRC under EU Regulations.
Note: First published Jul 2019; updated and revised in Aug 2021.