Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
Article 15 of the MDR and IVDR requires manufacturers to have at least one Person Responsible for Regulatory Compliance (PRRC) with defined qualifications. We help scope the role, and - for micro and small manufacturers outside the EU - can make a qualified PRRC permanently available through our Authorised Representative service.
Article 15(1) requires the PRRC to hold either a diploma, certificate or other evidence of formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline plus at least one year of professional experience in regulatory affairs or quality management systems relating to medical devices, or four years of professional experience in regulatory affairs or quality management systems relating to medical devices without such a qualification.
The PRRC is responsible for tasks including conformity checking before release, technical documentation and declaration of conformity maintenance, post-market surveillance obligations, and vigilance reporting (Article 15(3)).
Article 15(2) exempts micro and small enterprises from having the PRRC within their own organisation, provided such a person is permanently and continuously at their disposal. For manufacturers established outside the EU that qualify as micro or small enterprises, Article 15(6) goes further: the Authorised Representative itself must have a qualified PRRC permanently and continuously available. This is the combination we offer - appointment as your Authorised Representative plus PRRC coverage as a priced add-on, from one provider with one relationship, rather than two separate contracts with two separate providers.
Note: Exact PRRC requirements depend on your company size and product classification. We confirm scope before quoting.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.