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 act as external PRRC for micro and small manufacturers represented by another Authorised Representative.
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)).
Manufacturers of custom-made devices may instead demonstrate the expertise with at least two years of professional experience within a relevant field of manufacturing (Article 15(1) MDR).
Article 15 of the IVDR sets the same PRRC requirement for IVD manufacturers: a relevant university-level qualification plus at least one year of professional experience, or four years of professional experience, in each case in regulatory affairs or quality management systems relating to in vitro diagnostic medical devices. The micro and small enterprise rule and the Authorised Representative's own PRRC apply in the same way as under the MDR.
The PRRC must at least ensure that:
Where several persons share the role, their areas of responsibility must be set out in writing (Article 15(4)), and the PRRC must suffer no disadvantage in the organisation for properly carrying out these duties (Article 15(5)).
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 - which can be an external PRRC. The Authorised Representative must separately have its own PRRC (Article 15(6)), and MDCG 2019-7 states that the PRRC of a micro or small enterprise and the PRRC of its Authorised Representative shall not belong to the same external organisation. We therefore act as external PRRC only for manufacturers represented by another Authorised Representative. If we are your Authorised Representative, your PRRC must come from a different provider.
A university-level 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 such experience (Article 15(1)). Custom-made device manufacturers may rely on two years of experience within a relevant field of manufacturing.
Yes. Article 15 IVDR follows the same structure, with experience relating to in vitro diagnostic medical devices.
Only for micro and small enterprises within the meaning of Recommendation 2003/361/EC: they do not need the PRRC within their organisation but must have one permanently and continuously at their disposal (Article 15(2)). Other manufacturers must have the PRRC available within their own organisation (Article 15(1)).
No. According to MDCG 2019-7, the PRRC of the manufacturer and the PRRC of its Authorised Representative cannot be the same person, and for micro and small enterprises they shall not belong to the same external organisation. That is why we act as external PRRC only for manufacturers whose Authorised Representative is another company.
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. Before you sign a mandate, we tell you what the next step is.