MDCG 2019-07 Guidance on Article 15 on the PRRC revised
9 January 2024
The Revision 1 of “Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) ” of the Medical Device Coordination Group (MDCG) was published in December 2023.
The revised guideline on the tasks and responsibilities of the PRRC intended for manufacturers, authorised representatives and PRRCs, contains some corrections and additions (see page 2 of the document). Manufacturers (and authorised representatives) are obliged to appoint a PRRC that meets the qualifications of Article 15. Both manufacturers and PRRCs are obliged to register with EUDAMED. Manufacturers must employ a PRRC on a permanent basis (with exception of small and medium-sized enterprises), whereas authorized representatives must only have permanent access to a PRRC.
The guideline specifies the necessary qualifications of PRRCs and the requirements for custom-made medical devices. It also addresses the location of the PRRC (inside or outside the EU) and the number of PRRCs in organisations consisting of parent companies and subsidiaries. Authorised persons and the role of the PPRC are not to be filled by a single person. The obligation to appoint a PRRC also applies to importers, distributors or other legal entities assuming the obligations of a manufacturer (Article 16(1)).
Most importantly, the MDCG 2019-07 document breaks down the responsibilities of the PRRC, mentioned in Article 15.3, by comparing them with the obligations of manufacturers in Article 10. It also provides guidance on the fulfillment of the PRRC’s obligations emphasizing that PRRCs must not be disadvantaged by the dutiful fulfillment of their tasks within the company.
