PRRC: The Person Responsible for Regulatory Compliance under Article 15, Qualifications and the Micro-Enterprise Rule

The PRRC is a named individual, not a department, and Article 15(3) gives that person five minimum tasks.

Article 15 has applied since 26 May 2021 under the MDR (Regulation (EU) 2017/745, Article 123(2) as amended by Regulation (EU) 2020/561) and since 26 May 2022 under the IVDR (Regulation (EU) 2017/746, Article 113(2)). Both acts are regulations, directly applicable in every member state without transposition, so Article 15 of each regulation binds every manufacturer that places devices on the market under the EU MDR and IVDR without a national version in between.

The sections below follow Article 15 paragraph by paragraph: which operators need a PRRC, who qualifies, the five responsibilities, the micro and small enterprise rule, the authorised representative's PRRC, the protection against disadvantage, the PRRC data in actor registration, what MDCG 2019-7 rev.1 explains, how to appoint the person, and what the pending revision COM(2025) 1023 would change.

What Is a PRRC?

A PRRC, the person responsible for regulatory compliance, is the individual whom MDR Article 15 and IVDR Article 15 require each manufacturer and each authorised representative to have, with proven expertise and at least five defined responsibilities for the regulatory compliance of its devices. The same article number carries the same role in both regulations, so a manufacturer of medical devices and a manufacturer of in vitro diagnostic devices read parallel rules; the custom-made route described below is set by MDR Article 15(1).

The PRRC sits next to the duties of the economic operators, but the role does not replace them. The manufacturer remains the legal addressee of Article 10 of both regulations, and the authorised representative of Article 11; the PRRC is the person inside, or at the disposal of, that operator who makes sure the Article 15(3) checks happen. The wider allocation of duties is set out under economic operators under the MDR and IVDR.

Which Operators Need Their Own PRRC

Five groups of operators need a PRRC under Article 15 and MDCG 2019-7 rev.1. The five groups are listed below.

• Manufacturers of medical devices and of in vitro diagnostic devices, as part of the manufacturer obligations under MDR and IVDR Article 10 (Article 15(1)).
• Authorised representatives of manufacturers established outside the Union (Article 15(6), set out in the authorised representative section below).
• Distributors, importers and other persons who take on the obligations of a manufacturer under Article 16(1), as explained under Article 16 MDR.
• Reprocessors of single-use devices, under reprocessing single-use devices under MDR Article 17.
• Producers of systems and procedure packs under MDR Article 22 whose pack becomes a device in its own right under Article 22(4).

MDCG 2019-7 rev.1 adds a group position: it expects each legal manufacturer within a group of companies to have its own PRRC, so one group-level person does not cover several legal entities.

Who Qualifies as a PRRC: The Two Routes of Article 15(1)

A PRRC qualifies under Article 15(1) of the MDR and the IVDR through one of two routes: a university degree 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, or four years of such experience. The MDR adds a third, narrower route for manufacturers of custom-made devices. The full wording sits in the consolidated MDR text on EUR-Lex; competent authorities may ask for the evidence behind each route, as the evidence section below explains.

The three routes compare as follows.

Route (a): A Degree Plus One Year of Experience

Route (a) combines a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or a course of study recognised as equivalent, in law, medicine, pharmacy, engineering or another relevant scientific discipline, with at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices (MDR Article 15(1)(a)). The list of disciplines ends with an open category, "another relevant scientific discipline", so the four named fields are not exhaustive. A degree obtained outside the Union counts too: MDCG 2019-7 rev.1 explains that it is sufficient for one member state to have recognised the qualification as equivalent.

Route (b): Four Years of Experience

Route (b) requires no degree, only four years of professional experience in regulatory affairs or in quality management systems relating to medical devices (MDR Article 15(1)(b)). The four years replace the formal education entirely, which opens the role to quality engineers and regulatory specialists who entered the field without a university degree. On this route the nature of the experience carries the whole qualification, so the experience test in the evidence section below matters more than on route (a).

The Two-Year Manufacturing Route under MDR Article 15(1)

Manufacturers of custom-made devices may meet the MDR Article 15(1) requirement with a PRRC who has at least two years of professional experience within a relevant field of manufacturing. No degree and no regulatory-affairs experience is required on this route; manufacturing experience takes their place. The route is available only for custom-made devices; what counts as custom-made is set out under custom-made devices under the MDR.

What Counts as Experience and How to Evidence It

MDCG 2019-7 rev.1 takes the view that administrative handling of documents and shadowing do not count as professional experience in regulatory affairs or quality management systems.

The guidance names three kinds of evidence a manufacturer keeps for its PRRC: a curriculum vitae, copies of the relevant certificates (degree diplomas, for example), and evidence of the professional experience. These records belong in the personnel file of the PRRC from the day of appointment.

Competent authorities may request this evidence during inspections under MDR Article 93(3)(b) and IVDR Article 88(3)(b). MDCG 2019-7 rev.1 cites "Article 83(3)(b) IVDR" for the IVDR power, which is an error in the guidance; the correct IVDR reference is Article 88(3)(b). The inspection powers themselves are part of market surveillance of medical devices.

The Five Minimum Responsibilities of Article 15(3)

Article 15(3) of the MDR and of the IVDR makes the PRRC responsible at least for five things: the conformity check before release, the technical documentation and the EU declaration of conformity, post-market surveillance, vigilance reporting, and the statement for investigational or performance-study devices. The five tasks and their references in each regulation are shown in the table below, with the article text available in the consolidated IVDR text on EUR-Lex.

The five tasks are a minimum, set by the words "at least" in Article 15(3); a manufacturer may give its PRRC further duties. The PRRC "ensures" each task rather than doing every step alone, and the manufacturer keeps its own obligations under Article 10 of each regulation. A release check, for example, can be performed by quality staff while the PRRC makes sure it happens before each device leaves the manufacturer.

Several PRRCs and Written Areas of Responsibility

A manufacturer may appoint several PRRCs who jointly carry the Article 15(3) tasks, but their areas of responsibility must then be stipulated in writing (MDR and IVDR Article 15(4)). For example, one PRRC may hold tasks (a) and (b) and a second PRRC tasks (c) to (e), provided the split is written down. The written split also shows a competent authority which PRRC answers for which task, so no task falls between two people.

The Micro and Small Enterprise Rule of Article 15(2)

Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC are not required to have the PRRC within their organisation, but they must have such a person permanently and continuously at their disposal (MDR and IVDR Article 15(2)). The size categories come from Article 2 of the Annex to Commission Recommendation 2003/361/EC, which Article 15(2) cites; the two thresholds are shown below.

Thresholds of Commission Recommendation 2003/361/EC, Article 2, as cited in MDCG 2019-7 rev.1.

Medium-sized and larger manufacturers have no such option. For them the PRRC must be "within their organisation", which MDCG 2019-7 rev.1 reads as an employee of the manufacturer. A manufacturer with 60 staff therefore cannot rely on an external PRRC, whatever its turnover, because it exceeds the small-enterprise headcount.

What "Permanently and Continuously at Their Disposal" Means

MDCG 2019-7 rev.1 reads "permanently and continuously at their disposal" as timely availability, which does not necessarily mean availability 24 hours a day. The external PRRC must be reachable when a task arises, such as a release decision, a serious incident report or an authority request, and must be able to act in time. The phrase "permanently and continuously" is also the wording the pending revision would delete for micro and small enterprises, as the revision section below shows.

Contracting an External PRRC

A micro or small enterprise may subcontract the PRRC function to a third party by contract, and MDCG 2019-7 rev.1 expects the contract to state the person's qualifications. The contract names the individual, not only the service company, because Article 15 attaches the qualification to a person; external PRRC services are among the services covered under MDR and IVDR consultants.

The external person still needs route (a), route (b) or the custom-made route of Article 15(1), with the same evidence as an employee. The protection of Article 15(5) also covers a contracted PRRC, because the article protects the person "whether or not" an employee of the organisation.

The Authorised Representative's PRRC under Article 15(6)

An authorised representative must have permanently and continuously at its disposal at least one PRRC with expertise regarding the regulatory requirements for medical devices in the Union (MDR and IVDR Article 15(6)), and this obligation does not depend on the size of the authorised representative. Unlike a manufacturer, an authorised representative has no in-house requirement: the person must be at its disposal, permanently and continuously, whether employed or contracted.

MDCG 2019-7 rev.1 presumes that this person is located in the Union, which is a guidance presumption and not an express requirement of Article 15(6). MDCG 2022-16 adds that an authorised representative whose mandates cover only legacy devices needs no PRRC. Mandates, duties and joint liability are set out under EU authorised representative for medical devices.

Non-EU Manufacturers: Two Separate PRRCs

A manufacturer established outside the Union needs its own PRRC, located according to MDCG 2019-7 rev.1 outside the Union near manufacturing, and its authorised representative needs a second, different PRRC. Two people therefore carry the Article 15 role for one device portfolio: one at the manufacturer and one at the authorised representative.

The authorised representative's PRRC cannot be the same person as the non-EU manufacturer's PRRC, according to MDCG 2019-7 rev.1, even when both entities belong to the same large organisation.

The whole set-up, from the mandate to registration, is covered under non-EU manufacturers under the MDR and IVDR.

No Disadvantage: The Protection of Article 15(5)

The PRRC shall suffer no disadvantage within the manufacturer's organisation for the proper performance of the Article 15 duties, whether or not the person is an employee (MDR and IVDR Article 15(5)). The protection covers the PRRC who, for example, stops the release of a device or reports an incident against the wishes of colleagues or management.

MDCG 2019-7 rev.1 counts dismissal and penalties among the disadvantages that MDR and IVDR Article 15(5) rule out. The protection attaches to the proper performance of the Article 15(3) tasks, so it covers the refusal to release a device as much as the reporting of an incident.

PRRC Details in the Actor Registration

The name, address and contact details of the PRRC are part of the data a manufacturer or authorised representative enters in EUDAMED actor registration under MDR Annex VI Part A Section 1.4, and actor registration has been mandatory since 28 May 2026. The process, roles and periods of that registration are explained under EUDAMED actor registration.

A change of PRRC is therefore also a change of actor data. The manufacturer or authorised representative updates the registration under the rules of the actor module whenever the person changes, alongside the internal appointment file.

What MDCG 2019-7 Rev.1 Adds to Article 15

MDCG 2019-7 rev.1, published by the MDCG in December 2023 to replace the June 2019 original, is the current guidance on Article 15 of the MDR and the IVDR on the Commission's MDCG list as of 6 November 2026, and it is not legally binding. Among the positions of the MDCG 2019-7 rev.1 document used on this page are these: "within their organisation" means an employee; each legal manufacturer in a group has its own PRRC; an external PRRC is engaged by a contract naming the qualifications; availability is timely, not necessarily 24-hour; shadowing and document handling are not experience; a non-EU degree counts when one member state recognises it; and Article 16(1) persons, MDR Article 17 reprocessors and MDR Article 22(4) pack producers also need a PRRC.

The legal force of these positions is limited. The MDCG acts under MDR Articles 103 and 105 and IVDR Articles 98 and 99; notified bodies take MDCG guidance into consideration under Annex VII Section 1.6.2 of both regulations. The full register by topic is kept under MDCG guidance.

How to Appoint and Document a PRRC

Appoint the PRRC in six documented steps before the first device is placed on the market, and keep the file ready for an authority inspection. The six steps are listed below in order.

1. Check the company size against Commission Recommendation 2003/361/EC to decide between an in-house and a contracted PRRC (MDR and IVDR Article 15(2)).
2. Check the candidate against route (a), route (b) or the MDR custom-made route, and file the CV, certificates and evidence of experience (MDR and IVDR Article 15(1)).
3. Assign the five Article 15(3) tasks, in writing where several PRRCs share them (MDR and IVDR Article 15(4)).
4. Sign a contract naming the person's qualifications where the PRRC is external, as MDCG 2019-7 rev.1 expects.
5. Enter the PRRC's name, address and contact details in EUDAMED actor registration (MDR Annex VI Part A Section 1.4).
6. Add the authorised representative's own PRRC where the manufacturer is established outside the Union (MDR and IVDR Article 15(6)).

The Commission's 12-step Implementation Model for the MDR, dated 1 August 2020, places this appointment in step 3, which tells manufacturers to "identify/hire the person(s) responsible for regulatory compliance within your organisation (Article 15) and be sure they are adequately qualified and trained". The model is Commission guidance, not law.

Training and Certificates: What Article 15 Recognises

Article 15(1) of the MDR and the IVDR recognises degrees, courses of study recognised as equivalent and professional experience, and no PRRC training certificate is required or recognised by either regulation. A course certificate therefore does not make a person a PRRC, and the lack of one does not disqualify a candidate who meets route (a) or (b).

Training still has a place: it supports the regulatory or quality-management experience a PRRC builds up, but it does not replace route (a) or route (b). The course types and who needs which are covered under MDR and IVDR training.

How the Pending Revision Would Change Article 15

The Commission's proposal for a targeted revision of the MDR and IVDR, COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), would simplify Article 15, but it is pending: as of 6 November 2026 the European Parliament lists it as "Awaiting committee decision" in its health committee (SANT). The procedure file on OEIL records the appointment of the rapporteur on 13 February 2026, a draft report of 30 June 2026 and amendments of 28 July 2026.

The proposal would replace the qualification list of Article 15(1) with "requisite expertise", and it would drop "permanently and continuously" from Article 15(2), so micro and small enterprises would only need the PRRC "at their disposal". Authorised representatives would keep the PRRC "permanently and continuously at their disposal" under Article 15(6), with requisite expertise and without the qualification list. Until an amending regulation is adopted and published, the current Article 15 applies in full.

The Commission calls the qualification requirements and the permanent and continuous availability "overly prescriptive" in recital (20) of the proposal. Every other change of the proposal is set out under MDR and IVDR amendments.

PRRC Questions

Five questions come up about the PRRC beyond the rules above.

What does PRRC stand for?

PRRC stands for person responsible for regulatory compliance, the role set by Article 15 of the MDR and of the IVDR.

Does a legacy device need a PRRC?

No: MDCG 2021-25 rev.1 lists MDR Article 15 among the MDR provisions that do not apply to legacy devices, so a manufacturer with only legacy devices needs no PRRC for them. The provisions that do apply are listed under legacy devices under the MDR.

Can several companies in one group share a PRRC?

No: MDCG 2019-7 rev.1 expects each legal manufacturer within a group to have its own PRRC.

Must the PRRC be located in the EU?

Not by express rule: MDR and IVDR Article 15(6) contain no express location requirement for the authorised representative's PRRC, but MDCG 2019-7 rev.1 presumes that this person is located in the Union and places a non-EU manufacturer's PRRC near manufacturing outside the Union.

Is a missing PRRC an offence?

In Germany, failing to have a PRRC under MDR Article 15 is an administrative offence (§ 94(3) Nos. 5 and 6 and § 94(4) Nos. 2 and 3 of the Medical Devices Implementation Act, Medizinprodukterecht-Durchführungsgesetz, MPDG). National penalties and authorities are covered under MDR and IVDR in Germany.