EU Authorized Representative vs Importer vs Distributor vs PRRC: Who Does What

The EU Authorized Representative vs importer question comes up because the two roles overlap in time but not in law. Your authorised representative (Article 11) is your legal address in the Union. Your importer (Article 13) first brings the device into the EU. Your distributor (Article 14) supplies it onward. Your PRRC (Article 15) is a qualified person, not a company.

"EU Authorized Representative", "EU authorised representative", "EC REP" and "EU REP" all name the same Article 11 role. Only the label symbol changed, to EU REP under EN ISO 15223-1:2021/A1:2025 (Commission Implementing Decision (EU) 2026/1231).

In brief

Only the authorised representative is a mandated legal stand-in for a non-EU manufacturer.
Importers verify an AR exists (Art. 13(2)(b)); distributors verify CE marking and UDI (Art. 14(2)).
Your PRRC and your AR's PRRC must be two different people (MDCG 2019-07 Rev.1).
Manufacturers, authorised representatives and importers register under Article 31. Distributors do not.
Article 11(5) makes the AR jointly and severally liable in defined circumstances.

The four roles in one table

The economic operators MDR recognises are the manufacturer, the authorised representative, the importer and the distributor. The PRRC is not one of them: it is a natural person with duties under Article 15. Two you appoint; the supply chain creates the rest. Read the table as a duty map, not an org chart.

Role	Legal basis	Who must hold it	Where established	Core duties	EUDAMED registration	Liability position
Authorised representative	MDR Art. 11; MDCG 2022-16	Any manufacturer with no registered place of business in a Member State. One sole AR, accepted in writing (Art. 11(1)-(2))	Within the Union (MDCG 2022-16); the MDR names no particular Member State	The Art. 11(3) list: verification, document retention, Art. 31 registration, information and samples, corrective action, complaints, termination on breach	Yes — Art. 31; receives an SRN	Art. 11(5): jointly and severally liable with the manufacturer for defective devices where the manufacturer has not complied with Art. 10
Importer	MDR Art. 13; MDCG 2021-27 Rev.1	The operator placing a third-country device on the Union market	Union-based; defined in MDR Art. 2, not Art. 13	13(2)(b) AR check; 13(3) own details; 13(4) registration; 13(5) storage and transport; 13(6) complaints register; 13(9) DoC copy	Yes — Art. 13(4) and Art. 31	Duty-based; becomes a manufacturer under Art. 16(1) on own-branding or modification
Distributor	MDR Art. 14; MDCG 2021-27 Rev.1	Anyone making a device available who is neither manufacturer nor importer	In the Union supply chain; defined in MDR Art. 2	Art. 14(2) pre-supply checks: CE marking, DoC, Art. 10(11) information, the importer's 13(3) details, UDI. Sampling permitted for points (a), (b) and (d) only	No. Art. 31 names manufacturers, ARs and importers only	Duty-based; same Art. 16(1) escalation
PRRC	MDR Art. 15; MDCG 2019-07 Rev.1	A natural person. ARs need one "permanently and continuously at their disposal" (Art. 15(6)); manufacturers hold their own	Art. 15 governs qualification and availability, not residence	Regulatory compliance oversight. Relevant degree plus one year in regulatory affairs or QMS, or four years' experience	No. Not an economic operator; no SRN	Not an Art. 11(5) or Art. 16(1) holder; the duty sits with the organisation

Authorised representative: MDR Article 11

Without a registered place of business in a Member State, you may place a device on the Union market only if you designate an authorised representative (Art. 11(1)). "Sole" is the operative word: one AR per manufacturer, not one per country.

What the mandate must do

The designation is valid only once the representative accepts it in writing, and covers at least all devices of the same generic device group (Art. 11(2)). Article 11(3) fixes the minimum tasks: verify the EU declaration of conformity and technical documentation have been drawn up and the conformity assessment carried out; keep copies of the documentation, DoC and certificates at the disposal of competent authorities; comply with its own Article 31 registration obligations and verify that you complied with Articles 27 and 29, because device registration itself is your duty under Article 29 and Annex VI Part A Section 2; provide information and samples on request and forward requests to you; cooperate on corrective action; pass on complaints from healthcare professionals, patients and users; and terminate the mandate if you act contrary to your obligations. Retention is 10 years, 15 for implantables (MDCG 2022-16).

What the mandate cannot do

Article 11(4) is the ceiling: a mandate cannot transfer the manufacturer's obligations under Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). Design, the quality management system, technical documentation, UDI assignment, labelling and language compliance stay with you.

Two more provisions matter. Under Article 11(6) an AR terminating a mandate must immediately inform its competent authority and, where relevant, the notified body. Under Article 11(7) the competent authority of the manufacturer's Member State is the AR's — choosing an AR chooses your regulator. Article 12 and a tripartite agreement (MDCG 2022-16) govern changing your EU authorized representative; see also MDR Article 11 explained and the EU authorized representative service.

Importer: MDR Article 13

The importer's first duty is a check on you: before placing a device on the market it must verify that the manufacturer is identified and an AR designated under Article 11 (Art. 13(2)(b)).

Importer obligations under Article 13

13(3) — name, registered trade name or trademark, registered place of business and contact address on the device, its packaging or an accompanying document.
13(4) — register in the electronic system and add its details.
13(5) — storage and transport conditions.
13(6) — a register of complaints, non-conforming devices, recalls and withdrawals.
13(9) — keep a copy of the EU declaration of conformity.

MDCG 2021-27 Rev.1 (December 2023) is the Q&A. Point 13(3) is one to design for: change importer and the artwork changes with it. Detail in importer obligations under Article 13.

Distributor: MDR Article 14

A distributor makes a device available without being the manufacturer or the importer, and its duties are verification duties. Under Article 14(2) it must verify, before supplying, the CE marking, that the EU declaration of conformity has been drawn up, that the Article 10(11) information is supplied, that the importer complied with Article 13(3), and that a UDI has been assigned.

Distributor obligations under Article 14

Nobody has to open every carton, but read the sampling allowance narrowly. Article 14(2) permits a representative sampling method for points (a), (b) and (d) only: CE marking and the declaration of conformity, the Article 10(11) information, and the UDI. Point (c), that the importer complied with Article 13(3), is excluded, so a missing importer block is caught on every consignment rather than on a sample. Sampling only helps if the plan is written down, because the plan is the evidence that verification happened. Note the omissions too: no duty to review your technical documentation, and none to check that you appointed an AR, which belongs to the importer under 13(2)(b) (distributor obligations under Article 14).

PRRC: MDR Article 15

The PRRC is a person, not a company or a subscription. Article 15(6) requires authorised representatives to have "permanently and continuously at their disposal at least one person responsible for regulatory compliance". Manufacturers carry their own Article 15 duty in parallel.

PRRC Article 15 qualification

MDCG 2019-07 Rev.1 (December 2023) gives two routes: a university-level diploma in law, medicine, pharmacy, engineering or another relevant scientific discipline plus at least one year in regulatory affairs or quality management systems; or four years of such experience. An AR's PRRC may be subcontracted if those criteria are met and a contract secures permanent and continuous availability.

The rule most often missed: the AR's PRRC and the non-EU manufacturer's PRRC cannot be the same person, even where manufacturer and AR belong to one organisation. At Medex the PRRC is a partner of the firm, with a deputy for continuity.

One caveat, clearly labelled. COM(2025) 1023 final, adopted by the Commission on 16 December 2025, proposes amending Article 15: it would remove the detailed PRRC qualification requirements and the "permanently and continuously" availability requirement for SMEs using an external PRRC. As of 20 August 2026 it is a proposal awaiting committee decision, so plan against Article 15 as it stands: PRRC under Article 15.

Can one company be both your AR and your importer?

On the EU Authorized Representative vs importer overlap, the rules neither prohibit nor endorse it. Nothing in Article 11, Article 13 or MDCG 2022-16 says one legal person cannot hold both roles, and nothing in the MDR requires the AR to be in the same Member State as the importer or the place of first placing. That presupposes two separately identified roles, not separate ownership.

EU Authorized Representative vs importer: two questions to keep apart

The first question is whether it is lawful; on the face of Articles 11 and 13, it is not forbidden. The second is whether it works. Two provisions create friction.

Article 13(2)(b) verification. The importer must verify that an AR has been designated. Where the importer is the AR, that becomes self-verification: not prohibited, but a competent authority may fairly ask how it was performed and recorded.
Article 11(3) termination. The AR must terminate the mandate if the manufacturer acts contrary to its obligations — an operator with a commercial interest in importing your product is being asked to end its own supply. Manage that conflict in writing.

Article 11(5) adds the commercial point: combining both roles concentrates the joint and several liability exposure on one balance sheet.

Medex holds two separate EUDAMED actor registrations, authorised representative SRN TR-AR-000057550 and importer SRN TR-IM-000056252, both publicly searchable. That is a statement of registration, not a bundled offer; our AR service excludes importing and distributing. Selection criteria are in our comparison of EU authorized representative companies.

What happens when a distributor relabels: Article 16

Article 16(1) is the trapdoor. A distributor, importer or other person assumes the obligations of a manufacturer if it markets a device under its own name or trademark, changes the intended purpose, or modifies the device so that compliance may be affected.

Article 16(2) carves out two activities that are not modifications: translating the information supplied with the device, and changing the outer packaging including pack size, provided the original condition is not affected. Conditions still attach: Article 16(3) requires the activity and the operator's details to be indicated and a QMS operated, and Article 16(4) requires 28 days' prior notice to the manufacturer and the competent authority plus a notified body certificate covering that QMS.

MDCG 2021-26 (October 2021) is the Q&A; the walkthrough is in MDR Article 16 relabelling and repackaging. COM(2025) 1023 proposes removing the certificate and the 28-day notice, but is not adopted: both apply today.

Which roles must register in EUDAMED

Three of the four. Under Article 31, manufacturers, authorised representatives and importers submit the Annex VI Part A Section 1 information before a device is placed on the market, custom-made devices aside. The competent authority verifies the data, obtains a Single Registration Number and issues it. Distributors are not in that list, and a PRRC is not an economic operator, so neither receives an SRN.

This stopped being optional. Commission Decision (EU) 2025/2371 (OJ 27 November 2025) declared four systems functional: economic operator registration; the UDI database and device registration; notified bodies and certificates; and market surveillance. Under Regulation (EU) 2024/1860 obligations apply six months after the notice, making those four modules mandatory on 28 May 2026. The vigilance and clinical investigation modules are not yet mandatory; the November 2025 roadmap points to an OJ notice for vigilance in Q4 2026, subject to audit results. Expected, not confirmed.

Sequence matters: you cannot register without an active authorised representative and a mandate summary document: the operator submits the request, the competent authority approves it, and EUDAMED generates the Actor ID and SRN, which you then use with a notified body. Our EUDAMED actor registration and SRN guide has the steps.

Nor is it a one-off filing. Data must be updated within one week of any change, and accuracy confirmed no later than one year after submission and every second year thereafter; failure to act within six months allows Member States to take corrective measures. The public database also lets you check any provider before signing.

Which roles carry liability, and how much

The manufacturer carries the most, the AR a defined joint and several exposure, and importers and distributors duty-based obligations that can escalate under Article 16(1).

Article 11(5) is the provision. Where the manufacturer is not established in a Member State and has not complied with its Article 10 obligations, the AR is "legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer". Both conditions matter: the exposure is triggered by your non-compliance, and it is joint and several, so a claimant need not exhaust remedies against you first. It does not move your obligations — Article 11(4) keeps those with you.

"How much" has no answer in the Regulation: the MDR sets no liability cap and no minimum insurance figure. Before signing, ask three things in writing: the representative's professional indemnity position, what happens to your technical documentation if it ceases trading, and which competent authority holds your file under Article 11(7). Rates by class are on our pricing page, with the reasoning in EU authorized representative cost. We are not a law firm and do not give legal advice.

A decision flowchart for non-EU manufacturers

These steps settle the EU Authorized Representative vs importer questions in order. Stop when the answer settles.

Are you established in an EU Member State, or selling only outside the EU? Either way Article 11 does not bite. Otherwise continue.
Designate one authorised representative established within the Union (Art. 11(1)), with written acceptance covering the whole generic device group (Art. 11(2)).
Draft the mandate against the Article 11(3) list, then check Article 11(4) for what stays with you. If a provider offers to take over Article 10 duties, ask on what basis.
Confirm you have your own PRRC and that your AR has a different one (Art. 15(6)).
Identify the importer on each route into the Union. It must verify your AR designation (Art. 13(2)(b)) and add its own details (Art. 13(3)).
Register in EUDAMED: active AR plus mandate summary, submit, await approval, collect the Actor ID and SRN (Art. 31). Your importer registers separately (Art. 13(4)).
Check whether anyone downstream will relabel, repackage or own-brand. If so, Article 16 binds them: 28 days' notice, a QMS and a notified body certificate, or they become the manufacturer.
Diarise maintenance: EUDAMED data updated within one week of a change, accuracy confirmed within one year and every second year after (Art. 31).
If you change representative, re-run steps 2 to 6 under Article 12, with an agreement covering termination and commencement dates, use of the outgoing AR's details, and document transfer.

Sources and further reading

Regulation (EU) 2017/745 (MDR), consolidated text of 10 January 2025, Articles 10 to 16, 30 and 31.
MDCG 2022-16, Guidance on Authorised Representatives, October 2022 (no revision as of August 2026).
MDCG 2021-27 Rev.1 on Articles 13 and 14, December 2023; MDCG 2021-26 on Article 16 repackaging and relabelling, October 2021.
MDCG 2019-07 Rev.1 on Article 15 PRRC, December 2023. MDCG 2021-13 Rev.1, July 2021, covers registration of actors other than manufacturers, authorised representatives and importers, so it does not govern the registrations on this page.
Commission Decision (EU) 2025/2371, OJ 27 November 2025; Regulation (EU) 2024/1860; Commission Implementing Decision (EU) 2026/1231, OJ 17 June 2026.
COM(2025) 1023 final, 16 December 2025, procedure 2025/0404(COD). Not adopted.

Frequently asked questions

Can my authorised representative also be my importer?

Nothing in Article 11, Article 13 or MDCG 2022-16 prohibits it, and MDCG 2022-16 confirms the AR need not sit in the importer's Member State. Two frictions remain: Article 13(2)(b) turns the importer's AR check into self-verification, and Article 11(3) obliges the AR to end the mandate for your non-compliance.

Do I need an importer if I ship direct to hospitals?

It depends whether a Union-based operator sits between you and the hospital. Article 13 duties attach to whoever is the importer, so if nobody performs that role, nobody holds them. The definition sits in MDR Article 2, not Article 13: read it against your shipping route.

Does a distributor need to register in EUDAMED?

Not under Article 31, which names manufacturers, authorised representatives and importers as the operators that submit Annex VI Part A Section 1 data and receive a Single Registration Number. Distributors obtain no SRN, but still carry Article 14(2) verification duties. National requirements are a separate question.

Do I need a PRRC if I already have an AR?

Yes. The duties are separate. You hold your own PRRC obligation under Article 15; Article 15(6) requires your authorised representative to have at least one PRRC permanently and continuously at its disposal. MDCG 2019-07 Rev.1 states they cannot be the same person, even within one organisation. COM(2025) 1023 proposes amending Article 15, but is not adopted.

Who is liable if a device is defective?

The manufacturer first: Article 11(4) keeps your Article 10 obligations with you whatever the mandate says. Article 11(5) adds that where a manufacturer is not established in a Member State and has not complied with Article 10, the authorised representative is legally liable for defective devices jointly and severally with it.

Get a fixed-price EU REP quote (reply within 1 business day). Send a device list with classifications through our contact page and you will receive a written proposal. Class-based rates are published, the setup fee is €0, and the fee is fixed for three years from signature.