How to Choose an EU Authorized Representative: A Buyer's Checklist for 2026

How to choose an EU Authorized Representative comes down to four checks you can verify yourself: an SRN you can look up in EUDAMED, a PRRC arrangement that is permanently and continuously available, written limits on what the mandate transfers under Article 11(3) and what it cannot under Article 11(4), and an exit clause that releases your documents. Price ranks last.

One point of vocabulary. "EU Authorized Representative", "EU authorised representative", "EC REP" and "EU REP" describe the same Article 11 role under the MDR, Regulation (EU) 2017/745, and the IVDR, Regulation (EU) 2017/746. "EU REP" is simply the newer label symbol.

In brief

• Verify the provider's SRN in the EUDAMED public actor database first.
• Article 11(4) caps what any mandate can transfer. Get the limits in writing.
• The AR's PRRC cannot be your PRRC (MDCG 2019-07 Rev.1).
• Exit terms decide your real cost: document release and Article 12 handover fees.

What an AR is actually selling you

Before working out how to choose an EU Authorized Representative, be clear what the product is. An AR sells legal presence and availability, not approval: an address inside the Union for competent authorities, a person permanently and continuously available (MDR Art. 15(6)), a custodian for your declaration of conformity, technical documentation and certificates, and an EUDAMED entry linking your devices to an economic operator (MDR Art. 31).

The Article 11(3) list is a minimum, not a menu, and Article 11(2) makes the designation valid only when the representative accepts it in writing, for the whole generic device group. See our EU Authorized Representative service page and the guide to MDR Article 11 authorised representative obligations.

Task	Who carries it	Reference
Verify the DoC and technical documentation exist	AR	Art. 11(3)
Hold documentation, DoC and certificates for authorities	AR	Art. 11(3)
Register as an economic operator, keep the registration current	AR	Art. 11(3)(c), 31
Register the device and assign the Basic UDI-DI	Manufacturer; the AR verifies it was done	Art. 29, 27; Art. 11(3)(c)
Pass on complaints, cooperate on corrective action	AR	Art. 11(3)
Terminate for breach, notify the authority	AR	Art. 11(3), 11(6)
The Article 10 duties listed in Article 11(4)	Manufacturer, not delegable	Art. 11(4)
Translating labels and IFU	Manufacturer	Art. 10(11), Annex I s.23
Answer an authority in that Member State's official language	AR	Art. 11(3)(d)

The 18 questions to ask any provider before you sign

Send these in one email and score the replies. A firm that answers eighteen specific questions in writing will answer a regulator the same way.

1. What is your SRN, and in which actor role? One number, in the authorised representative role, that you can find yourself in the EUDAMED actor database. Registration promised after signature is not registration.
2. Will you send the mandate template before I pay? It should arrive unredacted within days. A contract released only after an invoice usually holds something the provider would rather you read late.
3. Which Article 11(3) tasks are in the mandate, and at which clause? Good answers map each task to a clause number. "We cover everything in Article 11" is impossible, because Article 11(4) forbids part of it.
4. Which obligations does the mandate expressly leave with me? It should name Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12) as non-delegable under Article 11(4). Anyone offering to assume them is misdescribing the law.
5. Which generic device groups does the designation cover? Article 11(2) makes it effective for at least all devices of the same generic device group. A per-device quote that never mentions groups is a warning.
6. Is your PRRC also PRRC for a manufacturer you represent? The only acceptable answer is no. MDCG 2019-07 Rev.1 bars one person from both roles, even inside a single organisation.
7. Who covers the PRRC role during holiday, illness or resignation? Article 15(6) requires a PRRC permanently and continuously at the AR's disposal, so look for a documented deputy. "Always reachable" is not an arrangement.
8. Is the PRRC employed or subcontracted? Subcontracting is allowed where the qualification criteria are met and a contract secures permanent and continuous availability (MDCG 2019-07 Rev.1). Avoiding the word hides the arrangement.
9. Do you review my technical documentation before signing, or afterwards? A provider that reviews it in due diligence and lists the gaps has priced your risk. One that signs first reads the file under regulator pressure.
10. Where is my documentation held, and how fast can you produce it? MDR sets no number, so any commitment is voluntary. The Swiss CH-REP rule of seven days (MedDO/ODim Art. 51 to 52) is a fair benchmark.
11. How long do you retain documents after the mandate ends? Ten years, fifteen for implantable devices, matching MDCG 2022-16, with storage inside the fee. Silence becomes a retention invoice the day you leave.
12. What is your response time to an authority request, and is it contractual? A number plus the clause containing it is a service level. A number that appears only on a website is marketing.
13. What insurance do you carry, and what does it exclude? Article 11(5) makes an AR jointly and severally liable for defective devices where the manufacturer has not complied with Article 10, so refusal to answer in writing is itself an answer.
14. On what grounds would you terminate, and who do you tell? Termination is for acting contrary to your obligations, hits the whole generic device group (MDCG 2022-16), and requires notice to the AR's competent authority (Art. 11(6)).
15. What does an Article 12 handover cost, and are documents released before payment? Article 12 requires it to be agreed between you, the outgoing AR where practicable, and the incoming AR. Look for a fixed fee and unconditional release.
16. What is included in EUDAMED registration, and what costs extra? A good answer states how Basic UDI-DI and UDI-DI records are counted and how many are covered, rather than letting per-record charges surface later.
17. Who pays for the EC REP to EU REP label change? The change is purely editorial and needs no notified body approval, with coexistence running 17 June 2026 to 17 June 2031 (Commission Implementing Decision (EU) 2026/1231).
18. Give me the three-year total, itemised, and what can raise it. One page with the annual fee, handover fee, registration scope and every per-item charge. A number that exists only after a sales call is not a quotation.

Establishment: which Member State, and why it matters

The AR must be established within the Union (MDCG 2022-16). The guidance stops there, and so does the Regulation: no particular Member State is required, and nothing obliges the AR to sit in the same one as the importer or the place of first placing. The Commission's Notice to Stakeholders on the EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) completes the rule: a manufacturer established outside both the EU and Türkiye designates a single authorised representative, in Turkey or in the Community, and one mandate reaches both markets.

Location still matters. Under Article 11(7), the competent authority of the manufacturer's Member State means the State where the AR is established, so your AR selects the regulator that handles your correspondence and Article 10a notices. Two things follow: establishment decides your regulator, and a Türkiye-established representative is inside that arrangement.

Ask every provider to state its establishment in writing, then verify it. Medex is established in Türkiye, with its head office in Ankara, a second office in İstanbul and an office in Gdańsk, Poland. The March 2022 notice recognises that establishment for the Union market. Medex is registered in EUDAMED as an authorised representative under SRN TR-AR-000057550, publicly searchable, and the mandate is stated on our site to cover the EU and Türkiye. Check every provider you shortlist in the EUDAMED public actor database.

Does the AR hold its own SRN and is it publicly verifiable?

Yes, and it is the fastest way to separate real eu authorised representative companies from resellers. Under Article 31 the competent authority verifies the submitted data and issues a Single Registration Number, so an SRN shows a regulator looked. The first four EUDAMED modules have been mandatory to use since 28 May 2026 (Commission Decision (EU) 2025/2371). Actor registration has been mandatory from that date; device data entry has a later backstop of 27 November 2026 under MDR Article 123(3)(e), inserted by Regulation (EU) 2024/1860, expressly covering legacy devices.

1. Open the EUDAMED public site and go to the actor search.
2. Search by SRN, or by company name if you have not been given one.
3. Check the role. A manufacturer or importer registration is not an AR registration.
4. Check the legal name and address against the entity named in the draft mandate.

Medex publishes its three registrations: authorised representative TR-AR-000057550, manufacturer TR-MF-000057496, importer TR-IM-000056252. The manufacturer registration is active in EUDAMED Production with UDI records for our own devices, and the importer registration is an active actor there. See the EUDAMED actor registration and SRN guide.

Is the AR's own quality system certified?

Ask, but do not treat it as a pass or fail gate. Neither the Article 11 task list nor the Article 15(6) PRRC requirement imposes a certified quality management system on the AR itself, and MDCG 2022-16 does not address AR quality systems at all. Certification of an AR is not an MDR requirement, so a provider holding none is not disqualified. Contrast Article 16(4), where a relabeller must hold a notified body certificate: when the MDR wants a certificate, it says so.

What you are testing is process control over the Article 11(3) duties: how the provider records the date a complaint arrived and was forwarded, how it version-controls your technical documentation, and how it meets the Article 31 duty to update EUDAMED within one week of a change. Medex makes no certification claim here, and will answer in writing if you ask.

PRRC: is it real, named and permanently available?

Article 15(6) requires authorised representatives to have permanently and continuously at their disposal at least one person responsible for regulatory compliance. Under MDCG 2019-07 Rev.1 that person needs a relevant university-level diploma plus one year in regulatory affairs or quality systems, or four years of experience. The role may be subcontracted where a contract secures availability. See our guide to PRRC requirements under Article 15.

The trap is sharing. The AR's PRRC and the manufacturer's PRRC cannot be the same person, even where both belong to one organisation (MDCG 2019-07 Rev.1). If you buy PRRC support from the firm holding your mandate, get written confirmation that two individuals are involved.

One item is open. COM(2025) 1023 proposes removing the detailed Article 15 qualification requirements and the permanent availability requirement for SMEs using an external PRRC. It is not adopted, so today's Article 15 is the law.

At Medex the person responsible for regulatory compliance is a partner of the firm, with a deputy for continuity, and carries the same responsibility for our own devices. We do not publish that person's name.

Insurance and Article 11(5) liability cover

Article 11(5) is why this matters. Where the manufacturer is not established in a Member State and has not complied with Article 10, the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. A representative with no cover is one whose share lands back on you.

Ask four things in writing. The limit, per claim and in aggregate. The policy type, since Article 11(5) concerns defective devices rather than professional error. Whether liabilities assumed under Article 11(5) are excluded, which would make the policy irrelevant. And whether cover survives termination, given the ten and fifteen year retention periods.

A certificate evidences a policy on a date, not that a claim would be paid. Medex does not publish an insurance limit, and you should not infer one from this page; we will state our position in writing on request. We are not a law firm and do not give legal advice.

Response-time SLA for competent authority requests

Article 11(3) requires the AR to give a competent authority information and samples on request and to forward requests to you, but sets no clock. The clocks sit elsewhere: Article 31 requires EUDAMED data to be updated within one week of a change, and its accuracy confirmed one year after submission and every second year thereafter.

Ask for a contractual response time and what it covers: acknowledging, forwarding, or producing documents. Ask what happens when you do not reply, because the Article 11(3) obligations continue regardless of your inbox.

Medex publishes one service level: information and competent authority requests are answered within one business day. We publish no onboarding time in working days, and we examine technical documentation during due diligence, before the mandate is signed.

Language coverage and time zones

Label and instructions-for-use language sits with the manufacturer, under MDR Article 10(11) and Annex I Section 23, and each Member State sets its own languages. Article 52(12) is a different rule and does not belong here: it governs the language of conformity assessment documentation for a notified body, not labelling. Your AR is not there to translate your labels. Language is not entirely outside its duties either, though: Article 11(3)(d) requires it to give a competent authority the information and documentation demonstrating conformity in an official Union language determined by that Member State. Ask a provider how it handles that request.

The variation is real: Germany requires German for labelling, allowing German or English for professional instructions for use in justified cases, while Belgium covers Dutch, French and German. The Commission's overview hosts the MDR table Rev. 3 of August 2025, summarised in our guide to EU language requirements for labels and IFU.

Ask which languages a provider will correspond in and what happens when a request arrives in one it does not work in. Escalation matters more than time zone. Medex operates from Ankara, İstanbul and Gdańsk and works in English and Turkish; we publish no wider language list, so ask any provider to confirm coverage in writing.

Can the same provider be your EU importer?

They are separate roles, and combining them concentrates risk. Article 13(2)(b) requires the importer to verify that an authorised representative has been designated under Article 11; if one company does both, that verification becomes self-certification. Article 13(3) to 13(9) then add the importer's own details on the packaging, its own registration, storage controls and a complaints register.

The sharper conflict is termination. Article 11(3) obliges the AR to terminate if you act contrary to your obligations, and Article 11(6) to tell its competent authority why; an importer holding your stock has a reason not to. Watch Article 16(1) too: marketing a device under its own name or trademark makes that company the manufacturer. See EU authorised representative vs importer vs PRRC and the EU importer service page.

Medex holds importer registration TR-IM-000056252 and manufactures its own devices. Our AR service scope excludes importing and distributing, along with design, quality systems, drafting technical documentation and notified body functions.

Contract clauses that cost you later

Read these six before the price page. Much of how to choose an EU Authorized Representative is contract reading, and most disputes with representatives are about exit, not performance.

• Document release on exit. Article 12 requires the transfer of documents, including confidentiality and property rights, to be defined between you, the outgoing AR where practicable, and the incoming AR.
• Termination grounds. They should match Article 11(3) and Article 11(6), not exceed them, and carry a cure period.
• Notice and auto-renewal. Twelve months' notice on an annual contract means two years of fees to leave.
• Price escalation. An unqualified right to change fees on notice is a blank cheque.
• Per-event charges. Fees per authority request or per document retrieved turn a fixed cost variable when you are already in trouble.
• Use of the outgoing AR's details. Article 12 requires the agreement to state how long the outgoing AR may still appear in your information, including promotional material.

The mechanics are in our guide to changing your EU authorized representative and the 30-day switching checklist. Our annual fees are fixed for three years from signature, setup is zero, and an Article 12 change of representative costs 150 euro. Rates are on our pricing page and benchmarked in EU authorized representative cost.

A scoring template you can copy

This is the part of how to choose an EU Authorized Representative that survives procurement. Score each provider 0, 1 or 2 per row, multiply by the weight and total; the maximum is 44.

Criterion	Score 2	Score 0	Weight	Your score
SRN and actor role	AR-role SRN you found in EUDAMED	None, or unfindable	3
Article 11(4) limits	Non-delegable duties listed in the mandate	Claims duties Article 11(4) forbids	3
PRRC arrangement	Deputy documented, separation confirmed	No deputy, or shared with yours	3
File review	Reviewed before signature, gaps in writing	No review	2
Custody and retention	Ten years, fifteen for implantables, inside the fee	Unstated or chargeable	2
Response time	Stated time that is also a contract term	Marketing claim only	2
Insurance position	Limit and exclusions in writing	Nothing in writing	2
Article 12 handover	Fixed fee, release independent of billing	Release conditional, fee unquoted	3
Three-year cost	Itemised written proposal	Number only after a sales call	2

How to choose an EU Authorized Representative when two providers tie

Three zeroes are fatal whatever the total: no verifiable SRN, no written Article 11(4) limits, no unconditional document release. Break a genuine tie on the file review row, because the provider that read your documentation before signing has priced your risk. That is the honest answer to any ec rep provider comparison: there is no single best eu authorized representative, only the one scoring highest on what you can check.

Red flags: the EUR 300 mailbox AR

At the bottom of the market there is a structural pattern rather than a particular company.

• No SRN you can verify. Or one resolving to a different entity or role. The actor module has been mandatory since 28 May 2026, so "we are registering" is a weak excuse.
• No named PRRC arrangement. No deputy, no answer on employment or subcontract, and no confirmation that the person is not also PRRC for a manufacturer on the books, which MDCG 2019-07 Rev.1 forbids.
• Refusal to state Article 11(4) limits in writing. A provider that will not record which obligations remain yours is hiding how narrow the service is. Article 11(2) also requires written acceptance of the designation; an invoice is not an acceptance.
• Document hostage clauses. Release conditioned on disputed payments, or a handover fee left blank. Article 12 expects the transfer to be defined in advance, not negotiated at the exit.
• Arithmetic that cannot work. A rock-bottom fee still has to fund ten years of custody, fifteen for implantables, EUDAMED upkeep and a qualified PRRC.

Expensive is not automatically safe, and the biggest provider is not the most attentive. The cheap tier fails on structure, and structure is checkable before signature, as our guide to the cheap EU authorized representative problem sets out. Knowing how to choose an EU Authorized Representative is mostly knowing which four documents to demand: the SRN, the mandate template, the insurance position and the handover terms.

Sources and further reading

• Regulation (EU) 2017/745 (MDR), consolidated text of 10 January 2025, Articles 10 to 16 and 30 to 31.
• MDCG 2022-16, Guidance on Authorised Representatives, October 2022 (no revision as of August 2026).
• MDCG 2019-07 Rev.1, Guidance on Article 15 PRRC, December 2023.
• Commission Decision (EU) 2025/2371 of 26 November 2025, Official Journal 27 November 2025; Regulation (EU) 2024/1860, which inserted the MDR Article 123(3)(e) device data backstop of 27 November 2026.
• Commission Implementing Decision (EU) 2026/1231 of 11 June 2026, Official Journal 17 June 2026.
• COM(2025) 1023 final, 16 December 2025, procedure 2025/0404(COD). Not adopted as of 20 August 2026.
• Commission overview of language requirements: MDR table Rev. 3, August 2025.
• Swissmedic MU600_00_016 v7.0, valid from 1 May 2026, for the CH-REP comparison only.

Frequently asked questions

How do I verify an EU authorised representative is real?

Search the EUDAMED public actor database for the SRN and confirm the role shown is authorised representative, not manufacturer or importer. Under Article 31 a competent authority issues the SRN only after verifying the data, so it evidences an assessment. Then check the legal name and address against the entity in the draft mandate.

Should my AR be in the same country as my notified body?

No rule requires it. MDCG 2022-16 states the authorised representative must be established within the Union and stops there; nothing in the MDR requires a particular Member State, or the same one as the importer or the place of first placing. The Commission's March 2022 EU-Turkey Customs Union notice puts a representative established in Turkey inside that rule too. Location does decide your regulator: under Article 11(7), the competent authority of the manufacturer's Member State means where the AR is established.

Does my AR need ISO 13485?

Not as a legal requirement. Neither the Article 11 task list nor Article 15(6) imposes a certified quality management system on the authorised representative, so a provider without certification is not disqualified. Compare Article 16(4), where a relabeller must hold a notified body certificate: the MDR says so when it means it. Judge documented processes instead.

What insurance should an AR carry?

The MDR sets no figure, so this is a commercial judgement. Article 11(5) makes the AR jointly and severally liable for defective devices where the manufacturer is not established in a Member State and has not complied with Article 10, so the question is not cosmetic. Ask for the limit per claim and in aggregate, the exclusions, and whether cover outlives the mandate.

Is a bigger provider always safer?

No. Size is not an Article 11 criterion and is a weak proxy for the things that are: a verifiable SRN, a PRRC permanently and continuously available under Article 15(6), written Article 11(4) limits, contractual response times and clean exit terms. A large firm can still route your file through a shared queue. Score structure, not letterhead.

Get a fixed-price EU REP quote (reply within 1 business day). Send a device list through our contact page for a written proposal against our published class-based rates, with the Article 11(3) tasks and the Article 11(4) limits set out before signature.