Person Responsible for Regulatory Compliance. A star is born!

When the EU commission came up a few years ago with the concept of Person Responsible for Regulatory Compliance (PRRC), the regulators’ aim was to reinforce the professionalism of both manufacturers and authorised representatives. No doubt member-states’ Competent Authorities were pretty fed up with the so-called “cow-boys selling medical devices as if they were selling socks” and the “brother of my brother living in the EU” authorised representatives not knowing what exactly their role and responsibility was.

Although the Medical Device Regulation (MDR) unveiled the requirements on qualification and role of such a person for the manufacturer, it remained silent on the PRRC role at the CE authorised representative. Some unclarities also remained regarding the qualification, and other practical details. In substance, the MDR added a new requirement for any manufacturer and authorized representative to designate a PRRC. The Person Responsible for Regulatory Compliance shall have a university degree or equivalent in a relevant course of study and 1 year relevant experience, or 4 years relevant experience. It also allowed that “Person” to be subcontracted for manufacturers in case of small and medium sized companies.

Less than one year from the applicability of the PRRC, the Medical Device Coordination Group (MDCG) has published today a Guidance document: “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)”.

Interesting to note that whilst Implementing acts, delegated acts and other legal instruments are far from being ready, the EU member-states decided to address the PRRC as a priority. Probably because it was considered as an “easy piece”… well not so sure about it.

The document addresses certain “grey zones”, regarding for example the PRRC qualification. On that aspect, it says that any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognised by an EU Member State! This means that if you are a non-EU manufacturer, your PRRC should have a degree recognised by an EU member-state. You will probably prefer to use the “experience” criteria of 4 years if you would know how painful this equivalence recognition procedure can be, in certain member-states.

Another interesting aspect in this guidance document is to consider that this “person” designated by the manufacturer should not be the same as the PRRC of the CE authorised representative (AR). First of all, the reason is to maintain a second degree of scrutiny (which is not existing for EU manufacturers by the way), secondly because of the geographical proximity to permit the permanence and continuity of availability. As such, it even mentions that the authorized representative and EU manufacturer PRRC should be located in the EU, and the non-EU manufacturer PRRC should not be located in the EU! Not so sure a physical presence is nowadays still a relevant criteria considering the hyper-connectivity we all live in, as well as one can travel in less than 24h anywhere in the world. Not sure an east coast US manufacturer with a Chinese PRRC would be more efficient than a French PRRC for the same manufacturer, but still.

Finally, not much more is described than what is already in the Medical Device regarding the job description of the manufacturer PRRC, while the AR PRRC should make sure the mandate is fulfilled by the CE authorized representative, but what does it mean in practice?

If this document has now the merit to exist, no doubt it will raise some additional questions/concerns from the industry. One thing is sure now: a star is born – the PRRC!

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