PRRC under Article 15 MDR: the medtech appointment with a qualification test written into law

Medtech has a named seat that most people in the industry can describe only vaguely, even though it now sits in every manufacturer in Europe. The PRRC. It arrived with the Medical Device Regulation, it replaced a German role that a generation of quality people had built careers on, and unlike almost anything else in the MDR it comes with a written qualification test you can check yourself against in two minutes.

For regulatory affairs and quality professionals in medtech, that written test is the opportunity. I write this from 16 years recruiting in pharma and medtech, where a named statutory function on a CV was reliably the line that moved a profile from the pile to the shortlist.

What the role actually owns

Article 15(3) lists the responsibilities, and they are narrower than the title suggests, which is what makes them enforceable. The PRRC has to ensure that device conformity is properly checked under the quality management system before a device is released. That the technical documentation and the EU declaration of conformity are drawn up and kept up to date. That post-market surveillance duties under Article 10(10) are met. That the reporting obligations in Articles 87 to 91 are fulfilled, which is the vigilance side, serious incidents and field safety corrective actions. And for investigational devices, that the statement required by Annex XV is issued.

Translated into a working week: release decisions cross this desk, the technical files have to be current rather than nearly current, complaints and trend data have to be looked at rather than filed, and when something goes wrong in the field the clock in Articles 87 to 91 starts running. Where several people share the function, Article 15(4) requires their areas of responsibility to be set out in writing, which in practice is the document you should ask to see before accepting the role.

The qualification test, written into law

Article 15(1) accepts two routes. Either a diploma, certificate or other evidence of formal qualification from a university degree, or a course a Member State recognises as equivalent, in law, medicine, pharmacy, engineering or another relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. Or four years of that professional experience without the degree. Manufacturers of custom-made devices have a third option, at least two years of professional experience in a relevant field of manufacturing.

Two details in that wording repay careful reading. The experience has to relate to medical devices, so time spent in pharmaceutical regulatory affairs does not automatically count, and I have seen candidates lose an appointment on exactly that point. And the degree list is broader than people assume. Law qualifies. Engineering qualifies. Another relevant scientific discipline covers a wide field, and the assessment of what counts sits with the manufacturer and, when it is checked, the notified body or the authority.

The German angle: a role that replaced a role

Until the MDR became applicable, German medtech ran on § 30 MPG and the Sicherheitsbeauftragter für Medizinprodukte. That appointment no longer exists in national law. The MPDG did not carry it over, and the tasks were restructured into Article 15 of the MDR.

If you built a career on the old title, this matters for how you write your CV. Recruiters searching German medtech still type Sicherheitsbeauftragter into the search bar, and hiring managers under thirty may not recognise it at all. Name both, and show which of the Article 15 duties you have actually carried since the change. The overlap is real but not complete, because the MDR pushed technical documentation and post-market surveillance further into the seat than the German provision ever did.

The small company clause, and why it created a market

Article 15(2) is the paragraph with the career consequences. Micro and small enterprises, defined by Commission Recommendation 2003/361/EC, do not need the PRRC inside the organisation, but they must have such a person permanently and continuously at their disposal. Authorised representatives fall under Article 15(6) and face the same requirement.

Europe has a very large number of small device manufacturers, and a great many of them read that paragraph and went looking for someone external. That is why an external PRRC market exists at all, with consultancies and independent professionals holding several mandates in parallel. It is real work with real exposure, and it is one of the few genuine self-employment routes in medtech regulatory affairs. Before you go there, be clear about what permanently and continuously at their disposal means for your availability and for how many mandates you can defend.

The protection clause nobody mentions in interviews

Article 15(5) says the PRRC shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of their duties, whether or not they are employees. That sentence exists because the regulator anticipated the obvious conflict, the release date against the release evidence.

What the MDR does not do is spell out a personal liability regime for the PRRC. How far national law, employment law and company law reach into that question is something to put to a lawyer rather than to a recruiter, and I would not accept a confident answer from either without reading the contract. What I will say from the hiring side: candidates who raise the topic calmly in the interview, ask how release conflicts have been handled in the past and ask to see the Article 15(4) split of duties, come across as more senior, not more difficult.

Who is hiring, and the routes in

Every device manufacturer placing product on the EU market needs the function, from a two-person orthopaedic implant company to a diagnostics group. The IVDR carries a mirror provision for in vitro diagnostics, so the same seat exists on the diagnostics side. Authorised representatives need one available. Distributors and importers, as such, do not carry the Article 15 duty, which candidates often get wrong when they describe their own employer.

The usual route in runs through regulatory affairs: RA specialist, RA manager, then the appointment, often held alongside the day job in a smaller company. The second route runs through quality management, where a quality management representative with technical documentation and vigilance exposure moves across. Clinical evaluation and post-market surveillance authors sit close to the seat as well, closer than they usually realise, because the Article 15(3) duties are mostly their output. If you are in pharma regulatory affairs and want to cross into devices, the honest path is to get device experience on your record first; my guide on regulatory affairs careers covers how those moves are read.

What a CV has to evidence for this role

Write the qualification route you meet, explicitly, in the words the regulation uses. If it is the degree plus one year, name the degree and the device experience. If it is the four-year route, make the four years unmistakable and device-specific. Then show the duties: which device classes and risk classes, which conformity assessment routes, which notified body, how many technical files you have maintained, what your part was in an audit or an unannounced inspection, how many vigilance cases and field safety corrective actions you have run. If you hold or held the appointment, or the old Sicherheitsbeauftragter appointment, put it in with dates. Applicant tracking systems filter on precisely those strings, which I cover in the guide on the ATS in pharma.

A note on salary

I will not quote a band. Pay in this seat depends on company size, on whether the appointment sits on top of an RA or QM leadership role, on device risk class, and on whether you hold it internally or as an external mandate. A single number without those variables would mislead you. The direction is reliable: the appointment sits above comparable RA work without it, and holding several external mandates changes the economics entirely.

Frequently asked questions

What qualifications does the MDR require for the PRRC?

Article 15(1) accepts either a university degree, or an equivalent recognised course, in law, medicine, pharmacy, engineering or another relevant scientific discipline plus at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, or four years of that professional experience without the degree. Manufacturers of custom-made devices may instead rely on at least two years of professional experience in a relevant field of manufacturing.

Can the PRRC be external?

For micro and small enterprises under Commission Recommendation 2003/361/EC, yes: Article 15(2) allows the person to sit outside the organisation as long as they are permanently and continuously at the company's disposal. Larger manufacturers must have the person available within the organisation. Authorised representatives may also use an externally available person under Article 15(6).

Did the PRRC replace the German Sicherheitsbeauftragter für Medizinprodukte?

In effect, yes. The appointment under § 30 of the old MPG was not carried over into the MPDG, and the duties were restructured into Article 15 of the MDR. The two are not identical in scope, because Article 15 reaches further into technical documentation and post-market surveillance.

Is the PRRC personally liable?

The MDR does not set out a personal liability regime for the PRRC, and Article 15(5) protects the person from disadvantage inside the organisation for doing the job properly. How far national employment, criminal and company law reach is a legal question that depends on the country and the contract, so take it to a lawyer rather than to a recruiter.

Sources

Regulation (EU) 2017/745 (MDR), Article 15 (EUR-Lex)
Regulation (EU) 2017/746 (IVDR) (EUR-Lex)
Medizinprodukterecht-Durchführungsgesetz, MPDG (gesetze-im-internet.de, German)
Commission Recommendation 2003/361/EC on the definition of micro, small and medium-sized enterprises (EUR-Lex)

© 28 July 2026 Andreas Schulz. All rights reserved. This article is career guidance, not legal advice; the regulatory text prevails.