The MDCG has just published its guidance on the PRRC, MDCG 2019-7 “Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC)”.
The guidance is largely unsurprising but I would like to highlight some points that are relevant to companies operating internationally and that have structured their PRRC functions by pooling or combining resources, such as combining the manufacturer and authorised representative in a single person or locating the PRRC outside the Union.
Points relevant for extra EU-manufacturers
The guidance clarifies some points relevant to international companies, which are not clearly defined in the MDR/IVDR and which may prompt companies to need to change their current PRRC implementation in an international (extra-Union) context:
- The PRRC for the manufacturer and for the AR cannot be the same person (see p. 5) – although this is not explicit in the MDR and IVDR, it is evident that with the increased supervisory role of the AR combination of these separate roles in one person would create a conflict of interest. For micro and small enterprises (who do not need to employ a PRRC for the manufacturer pursuant to article 15 (2) MDR and IVDR) this translates to the situation that not only can the PRRC for the manufacturer and AR not be the same person, they can also not be provided by the same consultancy organisation (p. 5), which will add to costs and complexity for smaller companies;
- The PRRC for the AR must be located in the EU because the AR is located in the EU – this is not an explicit requirement in the MDR/IVDR but has been clarified now (p. 3). The manufacturer PRRC can however be located outside the EU; and
- The PRRC qualifications must be proven by demonstrated member state equivalency, meaning that the company will need to check the recognition of any non-EU diplomas by member states and document this for the PRRC (p. 1).
What else the guidance clarifies
The guidance provides a level of detail with regard to the cross-links between the manufacturer responsibilities under article 10 MDR/IVDR and the PRRC minimum responsibilities set out in article 15 (3) MDR/IVDR. This is helpful and convenient for drafting QMS procedures for implementing the PRRC function in the manufacturer organisation.
The guidance further clarifies that the manufacturer PRRC must be employed, except when the manufacturer is a micro or small enterprise.
If a company has multiple (“legal”) manufacturers under a single parent company then each of these must appoint its own PRRC. The guidance does not specify if these multiple PRRC functions cannot be combined in the same person or distributed over the same group of people if the manufacturers share a QMS or if this is implemented with quality agreements. I would assume however that this is possible.
What the guidance does not clarify
One of the big questions remains unanswered: the potential liability of the PRRC, which is important with regard to the structuring of the PRRC’s mandate and possible indemnification by the company, as well as how to structure that the PRRC does not suffer disadvantage of proper fulfilment of his/her duties. Since this is not explicitly addressed in the MDR/IVDR, it becomes relevant in the implementation of the MDR and IVDR in national law.
For example, the Dutch legislative proposal for the MDR/IVDR implementation provides without any clarification (that I have been able to find in the legislative history for the implementation act) that infringement of article 15 (3) MDR/IVDR (which sets out the PRRC responsibilities) is subject to competent authority enforcement by means of administrative fines and penalty payments. It is unclear (to me anyway) whether this enforcement may be directed against the company (I would assume so) or also against the PRRC (when not exercising responsibility for the functions that the PRRC should at least assume responsibility for). Hopefully this will be cleared up at some point because under the current circumstances it makes it potentially rather unattractive and risky to be a company’s PRRC in the Netherlands.