External PRRC Services — Person Responsible for Regulatory Compliance
Article 15 of MDR 2017/745 requires a Person Responsible for Regulatory Compliance (PRRC) who is permanently and continuously at your disposal. For a manufacturer with twelve employees, hiring one is rarely realistic — and for micro and small enterprises, the regulation doesn’t require it.
The role
What Is a PRRC?
Every manufacturer placing medical devices on the EU market must have at least one Person Responsible for Regulatory Compliance: a named person, with verified regulatory expertise, accountable for the compliance duties that Article 15 of MDR 2017/745 defines.
Article 15(3) makes the PRRC responsible for ensuring that:
- the conformity of devices is appropriately checked before release;
- the technical documentation and the EU Declaration of Conformity are drawn up and kept up to date;
- post-market surveillance obligations are complied with;
- vigilance reporting obligations are fulfilled.
Obligations
Who Needs One?
Manufacturers
Every manufacturer placing devices on the EU market must have at least one PRRC — regardless of device class and of where the company is based. Micro and small enterprises — fewer than 50 employees and annual turnover or balance sheet total not exceeding €10 million (Recommendation 2003/361/EC) — may appoint an external PRRC instead of employing one. Medium and large manufacturers must have the role within their organisation.
Authorised Representatives
An authorised representative must have its own PRRC, permanently and continuously at its disposal — and guidance MDCG 2019-7 makes clear this cannot be the same person as the manufacturer’s PRRC. The two roles stay separate to preserve independence.
Importers and distributors have their own obligations under Articles 13 and 14 of MDR 2017/745, but no PRRC requirement.
The case
Why External?
1 · Impartiality
An in-house PRRC reviews the work of colleagues, often reporting to the person with the strongest interest in releasing the product. An external PRRC has no such conflict: the verification Article 15 asks for is independent by construction.
2 · Guaranteed qualification
The Article 15 requirements are met and documented from day one: degree, experience and supporting evidence, ready for any Notified Body or authority question.
3 · Immediate availability
No three-to-six-month recruitment process in a market short of qualified candidates. The role is covered from the day the appointment letter is signed.
4 · Cost
A monthly retainer instead of a full-time salary, employer costs, recruitment fees and a workstation — and it scales with your portfolio, not with a headcount decision.
Article 15
Qualifications
Article 15 accepts two alternative routes to qualification:
- 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.
My qualification follows both routes: Physics graduate with 14 years of professional experience, specialising in medical device regulatory affairs and quality management systems — qualified to serve as Person Responsible for Regulatory Compliance under Article 15 of MDR 2017/745. The full qualification pack — degree, CV and evidence of experience — is provided with the appointment letter.
Pricing model
Service Models
Three service models, monthly retainer, no hourly billing, no hidden fees. The exact figure depends on your device portfolio — request a quote and you’ll have it within 24 hours.
Essential
For Class I devices with established quality systems.
- Appointment letter and full qualification pack
- Semi-annual compliance reviews
- Email and phone support
- Vigilance support when cases arise
Standard — recommended
For growing companies with several devices.
- Everything in Essential
- Portfolio-wide coverage
- Quarterly compliance reviews
- Ad-hoc support with agreed response times
Dedicated
For complex portfolios and Class IIa/IIb devices.
- Everything in Standard
- Monthly alignment meetings
- Defined availability hours
- Priority response for urgent matters
- Annual compliance report to management
Additional services — devices beyond those included, urgent reviews, meetings with authorities, team training — are quoted separately.
Scope and limits
What a PRRC Does Not Do
The PRRC appointment does not transfer the manufacturer’s legal responsibility. The manufacturer remains solely responsible for the conformity of its devices.
What the role does is give you the qualified oversight Article 15 requires: verification, monitoring and attestation by a named, qualified person. The following are not part of the PRRC role:
- Day-to-day quality management
- Supervision of production processes
- Design and development work
- Customer support
- Legal representation before authorities
Each of these is available as a separate engagement — see Compliance Projects.
Questions
Frequently Asked Questions
Can the same external PRRC serve both a manufacturer and its authorised representative?
No. Guidance MDCG 2019-7 requires the authorised representative’s PRRC to be a different person from the manufacturer’s: the two roles must remain independent. I can serve either role — not both for the same device chain.
We are based outside the EU. Do we need a PRRC?
Yes. The Article 15 obligation applies to every manufacturer placing devices on the EU market, wherever the company is based. Your EU authorised representative also needs its own, separate PRRC.
What does “permanently and continuously at their disposal” mean in practice?
An ongoing arrangement with defined availability and response times — not a one-off consultancy. The service models above exist to give that phrase contractual substance: a named contact, agreed response times, scheduled reviews.
Our company has more than 50 employees. Can we still outsource the PRRC role?
No. Outsourcing is reserved for micro and small enterprises under Recommendation 2003/361/EC. Medium and large manufacturers must have the PRRC within their organisation — what I can offer is support in qualifying and coaching an internal candidate.
How quickly can coverage start?
After the free initial assessment and a short due-diligence review of your documentation, coverage starts with the signed appointment letter — typically a matter of days rather than months, depending on how ready your documentation is.
Ready to Talk About Your Article 15 Obligation?
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Regulatory information last reviewed: 10 August 2026