Who Is the PRRC (Person Responsible for Regulatory Compliance) and What Are the Requirements?
Short answer: The PRRC (Person Responsible for Regulatory Compliance) is the competent person that every manufacturer and every authorised representative must have within its organisation under Article 15 of the EU MDR (Regulation (EU) 2017/745). There must be at least one; qualification requires either a degree in law, medicine, pharmacy, engineering or another relevant science plus one year of experience in regulatory affairs or quality management for medical devices, or four years of professional experience in those areas. The PRRC must not be disadvantaged within the organisation for performing the role.
Key takeaways
- Who must appoint one: manufacturer + authorised representative. Importers and distributors have no PRRC obligation.
- Duties (Article 15(3)): checking device conformity before release; keeping the technical documentation and DoC up to date; PMS obligations (Art. 10(10)); vigilance reporting (Arts. 87–91); the statement for investigational devices (Annex XV).
- Micro/small enterprise: need not employ the PRRC on staff but must have one permanently and continuously available (outsourcing is possible).
- Authorised representative: must have a PRRC permanently and continuously at its disposal; may outsource.
- Do not confuse it with national "responsible person" roles for distributors/sales outlets — a different function.
This article is part of the What is the EU MDR? pillar and complements economic operators.
Qualification requirements (Article 15(1))
One of the following:
- A diploma/certificate attesting to at least four years of university study (or equivalent) recognised by a member state in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or quality management systems relating to medical devices; or
- At least four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
For custom-made device manufacturers: at least two years of professional experience in the relevant field of manufacture is sufficient.
Evidence that the PRRC holds the required expertise (diploma, CV, experience records) is kept in the technical/quality documentation.
Duties (Article 15(3))
The PRRC is responsible at least for:
- Ensuring that devices are checked for conformity before release, in line with the manufacturer's quality management system.
- Preparing and keeping up to date the technical documentation and the EU declaration of conformity.
- Compliance with the post-market surveillance obligations (Article 10(10)).
- Fulfilment of the vigilance reporting obligations (Articles 87–91: serious incidents, FSCAs, trend reports).
- Issuing the statement in Annex XV Chapter I Section 4.1 for investigational devices.
Where several people share different areas of responsibility, the split must be defined in writing.
Independence and position
- The PRRC must not suffer disadvantage within the organisation for performing the role (Article 15(4)) — organisational independence is expected; ideally it reports to senior management and is separate from production/sales targets.
- Manufacturer: the PRRC must, as a rule, be within the organisation; only micro and small enterprises may use an external PRRC (still "permanently and continuously" available).
- Authorised representative: the PRRC must be "permanently and continuously at its disposal"; outsourcing is explicitly allowed.
- For how many organisations can one person be PRRC? The MDR gives no number; but the "permanently and continuously available" principle effectively limits one person from being PRRC for an unreasonable number of organisations (MDCG 2019-7).
The PRRC and the quality management system
The PRRC role is made concrete in the QMS through a job description, appointment record and authority matrix. In an audit, the notified body looks for: the appointment letter, evidence of qualification, the definition of tasks and responsibilities, the PRRC's access to decision processes (design review, CAPA, release, vigilance), and the independence arrangement.
How it differs from national "responsible person" roles
Several countries have a national "responsible person" requirement for medical device sales outlets and certain distribution/import activities (for example, in Türkiye, a "sorumlu müdür" under the sales outlet authorisation, with its own regulation and training/exam conditions). That role is not the same as the PRRC in MDR Article 15:
| PRRC (MDR Art. 15) | National responsible person (e.g. TR sales outlet rules) | |
|---|---|---|
| Who it binds | Manufacturer + authorised representative | Medical device sales outlet (retail/distribution) |
| Purpose | Device conformity, technical file, PMS, vigilance | Compliant operation at the point of sale |
| Legal basis | EU regulation | National regulation |
A company can be subject to both; the roles must be met separately.
Frequently asked questions
Must an importer/distributor appoint a PRRC? No. The PRRC is mandatory only for the manufacturer and the authorised representative.
Can the PRRC be outsourced? Yes for the authorised representative and micro/small manufacturers. For medium/large manufacturers the PRRC must be within the organisation.
Can the PRRC and the ISO 13485 management representative be the same person? Yes, if the qualification and independence conditions are met; but the job descriptions must be written separately.
Is the PRRC personally liable? Article 15 protects the PRRC from being disadvantaged within the organisation for performing the role; personal legal liability varies by national law.
What should I keep as evidence? The appointment letter, diploma/certificate, a CV and references showing experience, and the definition of tasks and responsibilities.
How MEGACERT helps
We provide PRRC qualification assessment, job description and QMS integration; and an outsourced PRRC service for authorised representatives and micro/small manufacturers. Let us review your PRRC setup in 30 minutes. → Contact
Sources
- Regulation (EU) 2017/745, Article 15. EUR-Lex.
- MDCG 2019-7 — Guidance on Article 15 of the MDR and IVDR regarding the Person Responsible for Regulatory Compliance (PRRC).
- Republic of Türkiye Official Gazette. Regulation on the Sale, Advertising and Promotion of Medical Devices (responsible person provisions).
- TİTCK. Guidance on medical device sales outlet authorisation and responsible person.
Last updated: 30 August 2026. General information only.