PRRC: The 5 Essential Duties of the MDR Article 15 Role

The PRRC — the person responsible for regulatory compliance — is the one named individual Regulation (EU) 2017/745 requires every medical device manufacturer to have, and the role is defined more tightly than most organisations realise. Article 15 fixes who qualifies (a relevant degree plus one year’s regulatory or quality experience, or four years’ experience), where the person must sit (within the organisation, except for micro and small enterprises), what the person is responsible for (five duties, from release checks to vigilance reporting), and how the person is protected (no disadvantage for doing the job). The IVDR carries an identical Article 15, and MDCG 2019-7 rev.1 of December 2023 interprets both. This guide sets out the qualification routes, the five responsibilities as the Regulation words them, the rules for small companies, authorised representatives and shared roles, and the four ways manufacturers get the appointment wrong.

Who qualifies as a PRRC

Article 15(1) 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”, demonstrated by one of two routes.

Two readings matter in practice. The experience in both routes is “relating to medical devices” — four years in pharmaceutical quality is not route (b) — and MDCG 2019-7 rev.1 adds that it should relate to the EU requirements and be “substantive, and recent”. And the qualification is personal: the Regulation names a person, not a department, and the notified body will ask for that person’s CV and evidence of the degree or the years.

The five PRRC responsibilities

Article 15(3) states that the person “shall at least be responsible for ensuring that” five things happen. The verb is ensuring, not performing — the person need not write the technical documentation, but is accountable for its existence and currency.

Where more than one person shares the role, Article 15(4) requires “their respective areas of responsibility” to be “stipulated in writing”. A company with a regulatory lead for (b) and (d) and a quality lead for (a) and (c) is compliant only if the split is documented. Our guide to MDR technical documentation covers what duty (b) actually maintains.

Where the PRRC must sit: three cases

MDCG 2019-7 rev.1 reads “permanently and continuously at their disposal” as permitting a micro or small enterprise to subcontract the role to an external organisation, “so long as the qualification criteria are met and the manufacturer can demonstrate and document how they can meet their legal obligations” — a contract that ensures the person’s permanent and continuous availability, not a name on a retainer. It adds two constraints the Regulation leaves implicit: a manufacturer located in the Union should have its PRRC located in the Union, and a corporate group with more than one legal manufacturer needs one for each legal manufacturer. On authorised representatives it is categorical: the person appointed by an authorised representative and by its non-EU manufacturer “cannot be the same person”, even within the same large organisation, and for a micro or small enterprise the two appointees may not belong to the same external organisation either, because the representative exists to add a level of scrutiny the manufacturer’s own person cannot supply.

Protection and independence

Article 15(5) is the provision most often left out of the job description: the person “shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation”. A person who blocks a release under 15(3)(a), or who reports a serious incident the commercial team would rather not report under 15(3)(d), is protected by the Regulation from the consequences. Notified bodies read this as requiring a reporting line that lets the person escalate to top management, and a written appointment that records it.

Four ways the appointment goes wrong

1. The named person does not qualify. A quality manager with three years in devices and a business degree meets neither route; the appointment is void from the start and every DoC since is exposed.
2. A medium-sized company uses a consultant. Article 15(2) permits an external person only for micro and small enterprises. At 50 employees or EUR 10 million, the person must be within the organisation.
3. The role is shared with nothing in writing. Article 15(4) requires the split to be stipulated in writing; two people who both assume the other handles vigilance is how an Article 87 deadline is missed.
4. The person is not registered. Annex VI Part A requires the name, address and contact details of the person responsible for regulatory compliance in the actor registration in EUDAMED, and a change is a registration update. Our guide to EUDAMED registration covers what became mandatory in May 2026.

Appointing the PRRC properly

1. Verify the route. Collect the degree certificate and a dated CV showing the device-related regulatory or quality experience; record which of 15(1)(a) or (b) applies.
2. Issue a written charter. The five 15(3) duties, the reporting line to top management, the 15(5) protection, and — where shared — the 15(4) split.
3. Wire the duties into the QMS. The release procedure, the technical documentation procedure, the PMS procedure and the vigilance procedure each name the person’s oversight step.
4. Register and keep registered. EUDAMED actor registration and the notified body’s records; update both on any change.
5. Cover absence. A deputy who also qualifies, or a written arrangement for the 15(3)(d) clock, which does not stop for holidays.

Frequently asked questions

What is a PRRC?
The person responsible for regulatory compliance required by Article 15 of the EU MDR (and the identical Article 15 of the IVDR): a named individual, qualified by a relevant degree plus one year of device regulatory or quality experience or by four years of such experience, who ensures release checks, technical documentation and the declaration of conformity, post-market surveillance, vigilance reporting and investigational-device statements.

Can the person be an external consultant?
Only for micro and small enterprises under Recommendation 2003/361/EC, which must have the person permanently and continuously at their disposal rather than within the organisation. Larger manufacturers must have the person within the organisation.

Can two people share the role?
Yes. Article 15(4) permits several persons to be jointly responsible, provided their respective areas of responsibility are stipulated in writing.

Does an authorised representative need one?
Yes. Article 15(6) requires the authorised representative to have at least one qualified person permanently and continuously at its disposal, and MDCG 2019-7 rev.1 treats it as a separate role from the manufacturer’s.

Is the person personally liable?
Article 15 makes the person responsible for ensuring the five duties are met and protects them from disadvantage for doing so; it does not create a personal liability regime. National law and the manufacturer’s own governance determine consequences.

Where this leaves you

Appoint the person as the Regulation describes the role: a person who qualifies by one of the two routes, sits within the organisation unless the company is micro or small, holds a written charter for the five Article 15(3) duties with any split stipulated, reports to top management under Article 15(5) protection, and is registered in EUDAMED. Then treat their duties as the spine of the QMS rather than a name on the org chart.

References

• Regulation (EU) 2017/745, consolidated text of 19 July 2026 — Article 15, Article 10(10), Articles 87 to 91, Annex VI Part A.
• MDCG guidance documents (European Commission) — MDCG 2019-7 rev.1 (December 2023), guidance on Article 15 of the MDR and IVDR.

More on the EU MDR

• PRRC: the Article 15 role — you are here
• EU MDR: Regulation (EU) 2017/745 explained
• MDR technical documentation: Annex II and III
• EUDAMED registration
• EU MDR transition deadlines
• Notified body fees under the MDR

The Person Responsible for Regulatory Compliance Charter, the Manufacturer Obligations Procedure, the Technical Documentation Procedure and the Vigilance and Serious Incident Reporting Procedure are in the EU MDR Toolkit, or start with the free templates.