Medical device and IVD regulations have specific responsibilities for this new role at manufacturers and Authorised Representatives
Article 15 of both the Medical Device Regulations and the In Vitro Medical Device Regulations have significant new requirements for appointing a ‘person responsible for regulatory compliance’. Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one such person. This person responsible for regulatory compliance has to meet minimum requirements for qualification and experience.
