EU Authorized Representative (EU REP) Services for Medical Devices and IVDs

An EU Authorized Representative is the person or company a manufacturer outside the EU must designate before placing a device on the Union market, under Article 11 of Regulation (EU) 2017/745 and its IVDR equivalent, Regulation (EU) 2017/746. The representative registers you in EUDAMED, holds your documentation for competent authorities and answers them on your behalf.

In brief

No registered place of business in a Member State means you need a sole authorised representative (MDR Art. 11(1)).
"EU Authorized Representative", "EC REP", "EU REP" and "authorised representative" are the same role.
The mandate must be accepted in writing and covers a whole generic device group (MDR Art. 11(2)).
EUDAMED actor registration has been mandatory since 28 May 2026; device data has a 27 November 2026 backstop.
Our fees are published by class, start at a €0 setup fee and are fixed for three years.

What an EU Authorized Representative actually is

An EU Authorized Representative accepts a written mandate from a non-EU manufacturer and carries out a defined list of regulatory tasks for that manufacturer's devices. It is a statutory role, not a marketing arrangement. Article 11(1) of Regulation (EU) 2017/745 is blunt: a manufacturer without a registered place of business in a Member State may place a device on the Union market only if it designates a sole authorised representative.

EC REP, EU REP and "authorized representative medical devices" all mean one thing

"EU Authorized Representative" (US spelling), "EU authorised representative" (British spelling), "EC REP", "EU REP" and the phrase people type most often, "authorized representative medical devices", all describe the same Article 11 MDR role. There is no legal difference between them. We use the US spelling in headings because that is what manufacturers search for, and the British spelling in regulatory text because that is how the Regulation is written.

One of those labels did change on the label. EN ISO 15223-1:2021/A1:2025 replaces the "EC REP" symbol with "EU REP", and Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 listed it as harmonised in the OJ of 17 June 2026. A 60-month coexistence period runs to 17 June 2031, and both symbols may be used on different packaging levels. The change is purely editorial and needs no notified body approval for relabelling. The mechanics are in our guide to the EC REP to EU REP symbol change.

Sole, and at least one whole generic device group

Two constraints in Article 11(2) shape every mandate. The designation is valid only once the representative accepts it in writing: a signed manufacturer-side form is not a designation until the other party signs back. And it is effective at least for all devices of the same generic device group, so you cannot put two products of a group with one representative and the third with a cheaper one. MDCG 2022-16 applies the same logic to termination, which affects the whole group.

Where the representative has to sit

MDCG 2022-16 states that the authorised representative must be established within the Union. It goes no further, and neither does the Regulation: on our reading nothing in Article 11 requires a particular Member State, or the same Member State as your importer or the place of first placing. That second half matters, because of Article 11(7): where the Regulation refers to the competent authority of the manufacturer's Member State, it means the State where the representative is established. Choosing a representative is also choosing the authority that handles your file. Before signing with anyone, including us, look up the provider in the public EUDAMED actor database. Our own registrations are below, and the market is compared on our EU authorized representative companies comparison page.

That requirement reaches Türkiye as well. The Commission's Notice to Stakeholders on the EU-Turkey Customs Union Agreement in the field of medical devices (DG SANTE, March 2022) confirms that a manufacturer established outside both the EU and Türkiye designates one authorised representative, in Turkey or in the Community, to reach both markets. The legal basis is Decisions No 1/95, 2/97 and 1/2006 of the EC-Turkey Association Council.

When you legally need one (and when you do not)

You need an EU Authorized Representative if your company has no registered place of business in an EU Member State and you want your device on the Union market. That is the whole test in Article 11(1), and it does not bend for device class, price or sales volume. Cases where it applies:

Class I self-certified devices. The requirement is independent of the conformity assessment route.
IVDs of every class, under Regulation (EU) 2017/746. MDCG 2022-16 is written for both Regulations.
Legacy devices under the transition in Regulation (EU) 2023/607, with deadlines of 31 December 2027 for Class III and Class IIb implantables (subject to the listed exceptions) and 31 December 2028 for other Class IIb, Class IIa and Class I sterile or measuring devices (Art. 120(3a)). That Regulation is a certificate timetable. It does not change who may place a device on the Union market.
Devices sold only to hospitals, laboratories or distributors. Placing on the market is the trigger, not the customer's identity.

Where you do not need one: if your company has a registered place of business in a Member State, Article 11(1) is not engaged, and a subsidiary that is the legal manufacturer inside the EU carries the manufacturer's obligations directly. That route has real costs of its own.

Two things an EU AR does not cover. Great Britain requires a UK Responsible Person under regulation 7A of the Medical Devices Regulations 2002; Switzerland requires a CH-REP under MedDO/ODim Articles 51-52 or IvDO Articles 44-45. Both are separate appointments, compared in the table below. Nor does a representative replace your person responsible for regulatory compliance: the AR's PRRC and the non-EU manufacturer's PRRC cannot be the same person, even inside one organisation (MDCG 2019-07 Rev.1). If those roles are blurred in your organisation chart, read EU authorized representative vs importer vs PRRC first.

Your Article 11(3) obligations, task by task

Article 11(3) sets the minimum content of every mandate. A representative may agree to do more; it may not do less. Here is the list, with what each line means when an authority calls.

Article 11(3) task	What it means in practice
Verify the EU declaration of conformity and technical documentation have been drawn up and the conformity assessment carried out	A documented review before the mandate starts, not a signature on trust
Keep a copy of the technical documentation, DoC and certificates at the disposal of competent authorities	Retention for 10 years, 15 years for implantable devices (MDCG 2022-16)
Comply with the Article 31 registration obligations, and verify that the manufacturer complied with Articles 27 and 29	Our EUDAMED actor registration, plus a documented check that your Basic UDI-DI and device data are filed, and one-week updates
Provide information and samples on request	Answering a competent authority's request inside its timeframe
Forward requests to the manufacturer	A defined escalation path so nothing sits in an inbox
Cooperate on preventive and corrective action	Working with the authority on field safety corrective actions and withdrawals
Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users	Complaints reaching the AR are routed to your vigilance system without delay
Terminate the mandate if the manufacturer acts contrary to its obligations	A duty, not an option. Termination affects the whole generic device group

Two adjacent duties catch people out. Under Article 11(6), a representative that terminates a mandate must immediately inform the competent authority of its Member State and, where applicable, the notified body, giving the reasons. Under Article 10a, in force since 10 January 2025, a manufacturer must notify anticipated supply interruptions that could cause serious harm at least six months in advance, including to the competent authority of the State where the manufacturer or its authorised representative is established. The Commission Q&A on Article 10a (Rev. 2, April 2026) is clear on ownership: "The manufacturer cannot delegate its legal responsibility for this task, however it can engage the assistance of its authorised representative."

What the mandate can never move off your desk

Article 11(4) lists the manufacturer obligations that cannot be delegated: those under Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). General safety and performance, risk management, clinical evaluation, technical documentation, UDI assignment, the QMS, post-market surveillance and the language of the information supplied with the device stay with you. Any provider offering to "take over compliance" is describing something Article 11 does not permit. The detail is in our guide to MDR Article 11 for authorised representatives.

What is included in our EU REP mandate

Everything in Article 11(3), written down before you sign, plus the registration work that follows:

Due diligence before signature. Your technical documentation is examined before the mandate is signed, not after an authority asks for it.
A written split of duties. The obligations transferring under Article 11(3) and those staying with you under Article 11(4) are set out in writing before signature, so no task is orphaned.
Written acceptance of the designation as Article 11(2) requires, covering at least the generic device group.
EUDAMED registration of the actor and device data, including the mandate summary document a non-EU manufacturer must submit.
Document retention for the periods MDCG 2022-16 sets: 10 years, and 15 years for implantable devices.
A named contact for authorities. Information requests and competent authority requests are answered within one business day.
A PRRC who is a partner of the firm, with a deputy for continuity, carrying the same responsibility for Medex's own devices. We do not publish the individual's name; Article 15 and MDCG 2019-07 Rev.1 set the standard, and you should ask any provider to evidence it in writing. See the Article 15 PRRC requirements.

Medex is registered in EUDAMED as an authorised representative under SRN TR-AR-000057550. It also holds manufacturer registration TR-MF-000057496, active in EUDAMED Production with UDI records for its own devices, and importer registration TR-IM-000056252. All three are publicly searchable in the EUDAMED actor database, so you can verify them rather than take a website claim at face value. Medex is established in Türkiye, with its head office in Ankara, a second office in İstanbul and an office in Gdańsk, Poland. That is the establishment the March 2022 Commission notice contemplates: one representative, in Turkey or in the Community, under a single mandate. It is a manufacturer as well as a service provider, so the documentation review is done by people who assemble the same files.

Not included, because it is not the representative's role: design, quality management systems, drafting technical documentation, importing, distributing and notified body functions. Those remain manufacturer responsibilities. Regulatory consultancy is available, quoted separately. We are not a law firm and do not provide legal advice.

What we do NOT charge extra for

Five things that other quotations often price as add-ons sit inside our annual fee. The list is complete: if something is not on it, ask, and we will quote it.

Setup fee: €0. There is no onboarding, activation or mandate drafting charge.
The first ten UDI-DI entries are included in the base fee.
Unlimited UDI-DI variants under the same Basic UDI-DI are covered by the base fee. One device means one Basic UDI-DI; sizes and configurations under it do not multiply the price.
Price stability. Fees are fixed for three years from signature, excluding VAT.
Coverage of two markets in one mandate. One mandate covers the EU and Türkiye.

One fee we publish rather than hide: a change of representative under Article 12 is €150. Exit costs are the line item most quotations leave blank, which is why ours carries a number. The wider market picture is in our breakdown of what an EU authorized representative costs.

EUDAMED registration and your SRN

EUDAMED is no longer optional. Commission Decision (EU) 2025/2371 of 26 November 2025, published in the Official Journal on 27 November 2025, declared four electronic systems functional: registration of economic operators; the UDI database and device registration; notified bodies and certificates; and market surveillance. Because Regulation (EU) 2024/1860 applies module obligations six months from publication of the notice, those four modules became mandatory to use on 28 May 2026. Any guidance still calling EUDAMED voluntary predates that date. Device data sits on a longer clock: MDR Article 123(3)(e), inserted by Regulation (EU) 2024/1860, gives manufacturers until 27 November 2026 to enter device data, expressly including legacy devices under Article 120(3), (3a) and (3b). Actor registration is already mandatory; device registration has that backstop.

Two modules are not yet mandatory: vigilance and post-market surveillance, and clinical investigations and performance studies. The Commission roadmap of November 2025 indicates an OJ notice for the vigilance module in Q4 2026, implying mandatory use around Q2 2027, explicitly subject to audit results. Treat that as expected, not confirmed.

The registration sequence for a non-EU manufacturer runs like this:

You appoint a representative and the mandate is accepted in writing. A non-EU manufacturer registering in EUDAMED must have an active authorised representative.
The representative submits the actor registration request, together with a mandate summary document.
The national competent authority assesses and approves the request.
EUDAMED generates the Actor ID / Single Registration Number. Under Article 31 the competent authority obtains the SRN and issues it to the economic operator after verifying the data.
You use the SRN when applying to a notified body and to access EUDAMED.
Device data is a separate step and a manufacturer duty. Under Article 29 you register the device before it is placed on the market, other than custom-made devices, using the Annex VI Part A Section 2 information. Article 11(3)(c) makes your representative verify that you did it, and that UDIs were assigned under Article 27.

Maintenance is then a live obligation. Data must be updated within one week of any change, and accuracy confirmed no later than one year after submission and every second year after that. Failure to act within six months allows Member States to take corrective measures. We hold that calendar for the entries we file; the walkthrough is in our EUDAMED actor registration and SRN guide.

Our onboarding process and service levels

The process is front-loaded: the document review happens before signature, so the mandate starts from a known position.

Send a device list. You receive a written proposal. No sales call is needed to get a number, because the class-based rates are published.
Due diligence. We examine the technical documentation, the EU declaration of conformity and the certificates, and identify gaps while they are still cheap to fix.
Scope the mandate. Generic device groups are agreed, because Article 11(2) makes the designation effective for at least a whole group.
Sign, and accept in writing. The Article 11(3) tasks we take on and the Article 11(4) duties that remain yours are listed in the mandate itself.
Register in EUDAMED. Actor registration and the mandate summary document, then device and UDI-DI data.
Update your labelling. Our name and address go on the label with the "EU REP" or "EC REP" symbol, inside the coexistence window to 17 June 2031.
Run the mandate. Requests answered within one business day, complaints routed to you immediately, EUDAMED entries kept current.

One published service level, stated honestly: the one business day response to information requests and competent authority requests. We do not publish an onboarding time in working days, because the approval step belongs to a competent authority and we cannot promise someone else's queue. To get a proposal against your own device list, send it to us and we will price it in writing.

Transparent annual pricing

Rates are published by class, per year, excluding VAT, and fixed for three years from signature.

MDR class	Annual fee	IVDR class	Annual fee
Class I	€800–1,000	Class A	€800–1,000
Class IIa	€1,000–1,300	Class B	€1,000–1,300
Class IIb	€1,200–1,600	Class C	€1,200–1,600
Class III	€1,500–2,000	Class D	€1,500–2,000

Alongside the annual fee: setup is €0 and a change of representative under Article 12 is €150. The EUDAMED service scope is one device equals one Basic UDI-DI, with unlimited UDI-DI variants under the same Basic UDI-DI covered by the base fee, and the first ten UDI-DI entries included. One mandate covers the EU and Türkiye.

Ranges exist because a Class IIb implant file and a Class IIb software file are not the same amount of work. The written proposal gives a single number, not a range. Current rates are on our pricing page; our cost breakdown lists what to ask every provider about: annual fee, per-generic-device-group charges, EUDAMED setup, document review, vigilance handling and the exit fee.

EU AR, UK RP and CH-REP: how they differ

Three markets, three appointments, three registrations. One provider can hold more than one, but no single appointment covers all three.

Point of comparison	EU authorised representative	UK Responsible Person (UKRP)	Swiss representative (CH-REP)
Legal basis	Article 11, Regulation (EU) 2017/745 (MDR), consolidated 10 January 2025	Regulation 7A, Medical Devices Regulations 2002 (SI 2002/618 as amended)	MedDO/ODim (SR 812.213) Articles 51–52; IvDO (SR 812.219) Articles 44–45
Who must appoint	A manufacturer without a registered place of business in a Member State (Art. 11(1))	A manufacturer established outside the UK. Importers and distributors do not appoint a UKRP	A manufacturer located in another country, by written mandate the representative accepts
Sole appointment	Yes, a sole authorised representative (Art. 11(1))	Yes, a sole UKRP	Not addressed in the sources used here; confirm with Swissmedic. A qualified person is required
Where established	Within the Union, or in Türkiye under the Customs Union arrangement (MDCG 2022-16; Commission notice, March 2022). No requirement to be in a particular Member State, nor the same one as the importer or the place of first placing	Established in Great Britain	In Switzerland
Core tasks	The Article 11(3) list: verification, retention, registration, information and samples, forwarding requests, corrective action, complaints, termination	Tasks mirror MDR Article 11(3)	Formal and safety-related issues connected with placing on the market
Registration	Actor registration and SRN under Article 31, in EUDAMED	All devices registered with the MHRA before being placed on the GB market	CHRN registration in swissdamed, format CHRN-[role]-[eight digits]. Device registration mandatory from 1 July 2026 for all devices and IVDs of all classes
Documentation availability	Technical documentation, DoC and certificates at the disposal of competent authorities; 10 years, 15 for implantables (MDCG 2022-16)	Mirrors the Article 11(3) obligations	Able to produce technical documentation within 7 days; retention 10 years, 15 for implantables
Labelling detail	Representative's name and address, with the EU REP or EC REP symbol	Not addressed in the sources used for this page	Name and address adjacent to the symbol; a PO box, email or telephone number alone is insufficient. Permitted wordings include "CH authorised representative" and "CH-REP"
Market-access timetable	MDR is the EU regime; transition deadlines run under Reg. (EU) 2023/607	CE-marked devices accepted in GB: MDD/AIMDD to 30 June 2028, and IVDD to 30 June 2030, in each case or expiry of the certificate, whichever is sooner; EU MDR and IVDR to 30 June 2030 (GOV.UK, Timelines for acceptance of CE marked medical devices in GB, refreshed 31 July 2026)	The EU–Switzerland MRA for medical devices lapsed in May 2021, so Swiss manufacturers are third-country manufacturers under MDR

Two open points to track rather than assume. The MHRA consulted on indefinite recognition of CE-marked devices between 16 February and 10 April 2026 and no outcome had been published as of 20 August 2026; its first proposal would move the GB MDD/AIMDD date from 30 June 2028 to 31 December 2028, but that is a proposal, not law. The UK core pre-market regulations are not yet made, but the MHRA published the draft Medical Devices (Amendment) Regulations 2026 on 13 May 2026 and notified it to the WTO, with adoption targeted for December 2026 and most provisions in force June 2027. In Switzerland, a swissdamed grace period runs to 31 December 2026 for devices first placed on the market after 1 July 2026, with no transitional period for devices subject to incident reporting or field safety corrective actions. Details are on our UK Responsible Person and Swiss authorised representative pages.

Liability, insurance and what Article 11(5) really means

Article 11(5) is the sentence that makes serious representatives read your file before signing. 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". Joint and several means a claimant can pursue the representative for the whole amount. Three consequences follow.

Document review is self-interest, not bureaucracy. A representative that never asks to see your technical documentation is carrying a risk it has not measured, which tends to surface as a refusal to act at the worst moment.
Termination is a duty. Article 11(3) obliges the representative to terminate if the manufacturer acts contrary to its obligations, and Article 11(6) obliges it to tell its competent authority, and where relevant the notified body, why. A representative cannot quietly stay on a non-compliant file.
Liability does not migrate. Article 11(4) keeps the listed Article 10 duties with you. Article 11(5) adds a party who can be sued; it does not remove one.

On insurance, we will be direct rather than impressive: Medex does not publish a professional indemnity limit or insurer, so this page states no figure. Ask us, and every provider you shortlist, for written confirmation of cover and its limit before you sign. The same applies to claims about staff numbers, mandate counts and certifications. Verify what can be verified: the EUDAMED public actor database shows whether a provider's registration exists and what role it holds.

Switching to us from another authorised representative

Changing representative is a defined procedure under Article 12, not a resignation letter. The arrangements must be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming one. MDCG 2022-16 calls this a tripartite agreement, waived where the outgoing representative is untraceable or has ceased operations. It must cover four things:

The date the outgoing mandate terminates and the incoming one commences, with no gap in cover.
How long the outgoing representative may still appear in your information, including promotional material, while labels and IFUs are reworked.
Transfer of documents, including confidentiality and property rights over them.
The outgoing representative's obligation, after the mandate ends, to forward any complaints or reports about suspected incidents to you or the incoming representative.

Registration and labelling work follows: EUDAMED actor and device data updated within one week of the change (Art. 31), and the label and IFU carrying the new representative's name and address, with the symbol covered by the coexistence window to 17 June 2031. Our handover fee is €150. The full checklist, including what to do when the outgoing provider has gone quiet, is in how to change your EU authorized representative.

One caution on timing: a non-EU manufacturer's EUDAMED registration depends on having an active representative, so plan the switch backwards from the commencement date, not forwards from your notice period.

Sources and further reading

Regulation (EU) 2017/745 (MDR), consolidated text of 10 January 2025, Articles 10, 10a, 11, 12, 13, 15 and 31. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02017R0745-20250110
MDCG 2022-16, Guidance on Authorised Representatives under Regulations (EU) 2017/745 and 2017/746, October 2022; no revision as of August 2026. https://health.ec.europa.eu/document/download/0a7613cb-6b9a-4396-a4c6-d2479e43e167_en
MDCG 2019-07 Rev.1, Guidance on Article 15 (person responsible for regulatory compliance), December 2023. https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf
Commission Decision (EU) 2025/2371 of 26 November 2025, OJ 27 November 2025, on the four first EUDAMED modules. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502371
Regulation (EU) 2023/607 and the Commission Q&A on it, Rev.2, July 2024. Regulation (EU) 2024/1860.
Commission Implementing Decision (EU) 2026/1231 of 11 June 2026, OJ 17 June 2026, listing EN ISO 15223-1:2021/A1:2025; MDCG 2021-5 Rev.1 Appendix, June 2026.
MDCG 2021-27 Rev.1, Q&A on Articles 13 and 14, December 2023.
Medical Devices Regulations 2002 (SI 2002/618 as amended), regulation 7A; GOV.UK, Timelines for acceptance of CE marked medical devices in Great Britain (GB), refreshed 31 July 2026; draft Medical Devices (Amendment) Regulations 2026, published 13 May 2026, not made.
Swissmedic MU600_00_016 v7.0, valid from 1 May 2026; MedDO/ODim (SR 812.213) Articles 51–52; IvDO (SR 812.219) Articles 44–45.
COM(2025) 1023 final, 16 December 2025, the proposed MDR/IVDR simplification package. Not adopted as of 20 August 2026, and not a source of current obligations.

Frequently asked questions

Do I need an EU Authorized Representative if I only sell to EU businesses?

Yes. Article 11(1) is triggered by placing a device on the Union market, not by the type of customer. Selling only to hospitals, laboratories or distributors is still placing on the market. A business-only model exposes the gap faster: under Article 13(2)(b) your importer must verify that an authorised representative has been designated.

Can my EU importer or distributor also be my authorised representative?

The guidance we rely on neither prohibits nor endorses one company holding both roles, and nothing in MDR Article 11 requires the representative to sit in the same Member State as the importer. The roles carry separate duties under Articles 11, 13 and 14 and separate registrations, and combining them means one operator verifies its own work. Treat it as an open question for your competent authority.

How long does it take to appoint an EU REP?

The mandate itself is quick; the timetable is set by your documentation and by a competent authority. Three steps gate it: the technical documentation review before signature, written acceptance of the designation (Art. 11(2)), and EUDAMED actor registration, where the competent authority assesses and approves the request before an SRN is generated. We publish no number of working days, because that approval is not ours to promise.

Can a competent authority inspect my authorised representative?

Yes. Article 11(3) requires the representative to keep a copy of the technical documentation, the EU declaration of conformity and certificates at the disposal of competent authorities, and to provide information and samples on request. MDCG 2022-16 sets retention at 10 years, 15 for implantables. Under Article 11(7), the authority where the representative is established acts as the authority for your file.

What happens if I do not appoint an EU AR?

You cannot lawfully place the device on the Union market: Article 11(1) permits placing only where a sole authorised representative has been designated. The practical blocks come first. Your importer must verify the designation (Art. 13(2)(b)), and a non-EU manufacturer cannot complete EUDAMED registration without an active representative and a mandate summary document.

Does the AR need to be in the same country as my importer?

No. MDCG 2022-16 states that the representative must be established within the Union, with no requirement to be in a particular Member State, nor in 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. The choice still matters: under Article 11(7), references to the competent authority of the manufacturer's Member State mean the State where the representative is established.

Can I have more than one EU authorised representative?

No. Article 11(1) requires a sole authorised representative, and under Article 11(2) the designation is effective at least for all devices of the same generic device group, so one group cannot be split between two providers. Whether different representatives may be used for different generic device groups is not settled by the guidance cited here; confirm that with the competent authority first.

Get a fixed-price EU REP quote (reply within 1 business day). Send your device list to our regulatory team and you will get a written proposal: one number per device, a €0 setup fee, and rates fixed for three years.