Does your person responsible for regulatory compliance meet the required criteria?”

Article 15 of both the Medical Device Regulations and the In Vitro Medical Device (IVD) Regulations have requirements for appointing a ‘person responsible for regulatory compliance’ (PRRC). Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one PRRC.  The Medical Device Coordination Group has recently endorsed and made available guidance on this topic. It should be noted […]