What Is a PRRC? EU MDR Article 15 Explained for Medical Device Companies
Quick answer: A PRRC — Person Responsible for Regulatory Compliance — is a named individual that every medical device manufacturer selling in the EU must have available under Article 15 of the Medical Device Regulation (EU) 2017/745. The PRRC personally verifies device conformity, technical documentation, post-market surveillance obligations, and vigilance reporting before products reach the market. Micro and small enterprises don't need to employ one in-house, but must have a qualified PRRC "permanently and continuously at their disposal" — which is why many SMEs contract an external PRRC, such as QLE Group in Brussels.
What the law actually requires
Article 15(1) of EU MDR requires manufacturers to have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. That expertise must be demonstrated by either:
a diploma, certificate or other 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.
This is not a ceremonial role. The PRRC's name appears in your quality management system, and competent authorities and notified bodies will ask who holds it — and whether that person's qualifications survive scrutiny.
What a PRRC is responsible for
Under Article 15(3), the PRRC is at minimum responsible for ensuring that:
Conformity of devices is appropriately checked against the QMS before release.
Technical documentation and the EU declaration of conformity are drawn up and kept up to date.
Post-market surveillance obligations (Article 10(10)) are complied with.
Vigilance reporting obligations (Articles 87–91) — serious incident reports and field safety corrective actions — are met.
For investigational devices, the required clinical investigation statement is issued.
Each of these is a personal verification duty. When a notified body auditor asks "who signed off on this PSUR?", the answer is the PRRC.
The SME exemption — and what it really means
Article 15(2) allows micro and small enterprises (as defined in Commission Recommendation 2003/361/EC) to not employ a PRRC within their organisation — provided they have such a person permanently and continuously at their disposal.
In practice, this means an SME can contract an external PRRC under a written mandate. What it does not mean is that the role can be nominal. "Permanently and continuously at their disposal" requires a real working relationship: access to your technical documentation, involvement in release decisions, and availability when a vigilance deadline lands.
What happens without a valid PRRC
A missing or unqualified PRRC is a direct nonconformity against EU MDR. Consequences include notified body findings during certification or surveillance audits, competent authority enforcement, and — commercially — a blocked or delayed CE certificate. It is one of the first things checked because it is one of the easiest things to check.
In-house hire vs. external mandate
Hiring a qualified full-time PRRC is expensive for a company with one or two devices, and the role rarely fills a full week. An external PRRC mandate gives you a named, qualified individual at a fraction of the cost — but only works if the provider accepts genuine legal responsibility, carries professional indemnity insurance, and actually runs (not just reviews) your compliance infrastructure.
Frequently asked questions
Does a Class I manufacturer need a PRRC? Yes. Article 15 applies to all manufacturers regardless of device class, including Class I self-certified devices.
Can one person be PRRC for multiple companies? Yes, an external PRRC may serve several manufacturers under separate mandates, provided they can genuinely discharge the duties for each.
Can the PRRC be held personally liable? The PRRC carries personal regulatory responsibility for the Article 15(3) duties. Serious providers back this with professional indemnity insurance — QLE Group's named-representative mandates are PI-insured to €1M.
Do authorised representatives also need a PRRC? Yes — Article 15(6) requires authorised representatives to have a PRRC permanently and continuously at their disposal as well.
About QLE Group
QLE Group is a Brussels-based regulatory practice providing outsourced PRRC mandates, ISO 13485:2016 quality management systems, and EU MDR compliance infrastructure for MedTech companies. Every mandate is delivered by Radoslav Milkov — qualified PRRC, ISO 13485 / 21 CFR 820 Lead Auditor, LL.M. in EU Law, and active European Commission external expert. Pricing is indexed to regulatory complexity and published transparently.
Need a PRRC? Book a 30-minute scoping call or write to info@qle.be.
