EU Authorized Representative Cost in 2026: Real Prices, Hidden Fees and Benchmarks
An EU Authorized Representative costs most non-EU manufacturers roughly EUR 800 to EUR 2,000 per year, priced by device class. Our published rates sit in that range with a EUR 0 setup fee. The spread you see between quotations usually comes from add-ons: EUDAMED entries, document review, vigilance handling and exit fees. Compare those line items, not headline numbers.
An EU Authorized Representative costs most non-EU manufacturers roughly EUR 800 to EUR 2,000 per year, priced by device class. Our published rates sit in that range with a EUR 0 setup fee. The spread you see between quotations usually comes from add-ons: EUDAMED entries, document review, vigilance handling and exit fees. Compare those line items, not headline numbers.
"EU Authorized Representative", "EU authorised representative", "EC REP" and "EU REP" all mean the same role: the person or company you designate under Article 11 of Regulation (EU) 2017/745 (MDR Art. 11(1)). The spellings differ; the duties do not. Our own figures below come from our published EU REP pricing page, not a sales conversation.
- EU Authorized Representative cost in 2026 is class-based: expect roughly EUR 800 to EUR 2,000 a year.
- Headline annual fees hide the real variance. Setup, EUDAMED and exit fees decide the total.
- Most providers publish no pricing at all, so like-for-like comparison takes a written line-item list.
- Article 11(3) duties are identical at every price point, and the exit fee is worth asking about before you sign.
The short answer: what you should expect to pay in 2026
Budget between EUR 800 and EUR 2,000 per year for a single generic device group, rising with risk class. That is the realistic EU Authorized Representative cost for most non-EU manufacturers in 2026, it is the band our published rates cover, and it is consistent with the few competitor prices that are publicly stated. Below it, look hard at what has been excluded. Above it, ask what extra scope you are buying.
What the annual fee should already include
A mandate fee should cover the minimum Article 11(3) tasks in full, because they are not optional: verifying the EU declaration of conformity and technical documentation exist and conformity assessment was carried out; keeping those documents at the disposal of competent authorities; complying with its own Article 31 actor registration obligations and verifying that you registered the device under Article 29 and assigned UDIs under Article 27; providing information and samples on request; forwarding authority requests to you; cooperating on corrective action; passing on complaints and user reports; and terminating the mandate if you act contrary to your obligations (MDR Art. 11(3)).
Two duties behind the fee are easy to overlook. The representative must keep your documentation available for the retention period, 10 years and 15 for implantables (MDCG 2022-16), and must have at least one person responsible for regulatory compliance permanently and continuously at its disposal (MDR Art. 15(6)) - a person who cannot also be your own PRRC, even inside one corporate group (MDCG 2019-07 Rev.1).
What drives the price: class, device count, generic device groups
The three variables behind EU Authorized Representative cost
Three variables move an EU authorised representative fee more than anything else: risk class, how many generic device groups you have, and how much registration work your portfolio generates in EUDAMED.
Risk class. A Class III device carries more documentation, more certificate handling and more authority contact than a Class I device, so it is priced higher almost everywhere. Resolve your class before requesting quotes; our MDR device classification guide covers the rules, and MDCG 2021-24 Rev.1 (April 2026) is the current guidance.
Generic device groups. This is the unit that matters legally and the one most often misread in a quotation. A designation is effective at least for all devices of the same generic device group (MDR Art. 11(2)), so a mandate is not naturally "per device" or "per catalogue number". If a provider quotes per device, ask how that maps onto the group your mandate has to cover. If it quotes per group, ask what happens when you add a device inside a group you already pay for.
Registration volume. Since 28 May 2026 the first four EUDAMED modules are mandatory to use, following Commission Decision (EU) 2025/2371 (OJ 27 November 2025). A portfolio with one Basic UDI-DI and a few variants is a different amount of work from one with forty, so any honest EU rep price depends on that count. Send a device list when you ask.
Line items most providers do not put on the website
Most of the real EU Authorized Representative cost hides below the annual fee. The line items below are where two identical-looking quotations stop being identical. Ask for each in writing.
| Line item | What to ask | Why it moves the total |
|---|---|---|
| Setup or onboarding fee | Charged once, per mandate, or per device group? | Can equal a full year in year one. |
| Per-generic-device-group fee | Annual fee per mandate or per group? | Three groups can mean three fees. |
| EUDAMED setup and UDI entries | How many UDI-DI records are included? | Variant-heavy catalogues generate hundreds. |
| Document review | Reviewed before or after signature, and billed separately? | Post-signature findings arrive as change orders. |
| Vigilance and authority handling | Included, capped hours, or hourly? | One FSCA can dominate the year. |
| Exit or transfer fee | What is charged to hand over under Article 12? | Only visible once you want to leave. |
| Professional indemnity insurance | What limit, disclosed in writing? | Article 11(5) liability sits with the representative. |
The insurance line deserves its own sentence. Where you are not established in a Member State and have not complied with Article 10, your authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, you (MDR Art. 11(5)). Ask any provider, including us, to state its cover in writing before you sign. We do not publish a figure, so ask directly rather than assuming one.
Published price benchmark across the market
Public benchmarking in this market is thin. Most providers publish no pricing at all, which is an observation about how the sector sells rather than a criticism of any firm. It means a buyer comparing four proposals is usually comparing four differently structured private quotes. The table below lists only figures the companies publish themselves.
| Provider | Published annual figure | Published setup position |
|---|---|---|
| Medex (this site) | EUR 800 to EUR 2,000 per year depending on MDR or IVDR class | Setup fee EUR 0; Article 12 handover EUR 150 |
| i3CGLOBAL | i3CGLOBAL publishes EUR 900 to EUR 1,500 per year | i3CGLOBAL publishes that a setup fee applies in addition |
| Patient Guard | Patient Guard publishes GBP 1,800 per year | Not stated here |
| Providers that publish nothing | Quotation only | Quotation only |
Read that table narrowly. It compares published headline numbers, not scope, and a GBP figure and a EUR figure are not comparable without a rate and a date, which we will not invent. Use published prices to set expectations, then compare written scope; there is a longer side-by-side in our EU authorized representative companies comparison.
One-off costs: onboarding, EUDAMED setup, document review
One-off costs land in year one and are where the largest unexpected invoices appear. There are three of them.
- Onboarding or setup. Drafting and signing the mandate, collecting documentation, confirming scope. The designation becomes valid only when the representative accepts it in writing (MDR Art. 11(2)). Our setup fee is EUR 0; where a provider charges one, ask whether it repeats per generic device group.
- EUDAMED actor and device registration. You, your representative and your importer submit the Annex VI Part A Section 1 information, the competent authority verifies it, and the system issues a Single Registration Number (MDR Art. 31). Device data is a separate filing you make under Article 29 using Annex VI Part A Section 2, with a backstop of 27 November 2026 under MDR Article 123(3)(e). A non-EU manufacturer needs an active authorised representative and a mandate summary document to register. See the EUDAMED actor registration and SRN guide.
- Document review. Someone must check the DoC and technical documentation exist and that conformity assessment was carried out; that is an Article 11(3) duty. The only question is when it happens and who pays. We examine technical documentation during due diligence, before signature. Review after signature means findings arrive as extra work once you have committed.
A fourth cost is yours alone: labelling. The EC REP to EU REP symbol amendment, EN ISO 15223-1:2021/A1:2025, is harmonised under Commission Implementing Decision (EU) 2026/1231, with coexistence from 17 June 2026 to 17 June 2031. The change is purely editorial and needs no prior notified body approval for relabelling (MDCG 2021-5 Rev.1 Appendix, June 2026), so artwork can follow your normal revision cycle. But no EC REP cost quotation covers artwork.
Recurring costs: annual mandate, updates, vigilance handling
Recurring cost is the annual mandate fee plus whatever your provider charges to keep registrations current and to handle events. Only the mandate fee is predictable, so the pricing basis of the other two matters more than their headline rate.
Registration upkeep. EUDAMED data must be updated within one week of any change, and its 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 (MDR Art. 31). That is standing maintenance, not a one-time filing. Confirm whether routine updates sit inside the annual fee.
Information and authority requests. Your representative must give competent authorities information and samples on request, and forward their requests to you (MDR Art. 11(3)). Ask for a response commitment in writing. Ours is one business day for information requests and competent authority requests.
Vigilance handling. The representative must immediately inform you of complaints and reports from healthcare professionals, patients and users, and cooperate on corrective action (MDR Art. 11(3)). Reporting itself stays with you, but not because of Article 11(4). Vigilance sits in Article 10(13), which is not in the Article 11(4) list of non-delegable duties - that list is Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). A mandate may therefore put vigilance tasks on your representative; the legal responsibility under Articles 87 and 88 is still yours. Article 10a supply interruption notifications work the same way - the Commission Q&A on Article 10a (Rev. 2, April 2026) states you cannot delegate legal responsibility but can engage your representative's assistance. Price the assistance, not the delegation.
The EUDAMED vigilance and clinical investigations modules are not yet mandatory. The Commission roadmap of November 2025 indicates an OJ notice for vigilance in Q4 2026, implying mandatory use around Q2 2027, explicitly subject to audit results. Treat that as expected, not confirmed, and ask how a multi-year rate will price it.
Exit costs: the fee nobody quotes you
An exit fee is what a representative charges to hand your file over when you move to another one. Ours is EUR 150. We publish it because it is the fee a buyer is least able to negotiate later: by the time you need it, you have already decided to leave.
The work behind it is defined by law. Article 12 requires the arrangements for a change of authorised representative to be set out in an agreement between the manufacturer, where practicable the outgoing representative, and the incoming one, covering termination and commencement dates, how long the outgoing representative may still appear in your promotional material, document transfer including confidentiality and property rights, and the outgoing representative's duty to keep forwarding complaints and reports about suspected incidents (MDR Art. 12). MDCG 2022-16 calls this a tripartite agreement, waived where the outgoing representative is untraceable or has ceased operations.
An exit fee is therefore not inherently unreasonable. Document transfer, label and registration changes, EUDAMED updates and the tripartite agreement are genuine work. What matters is that the number is known before you sign, and that it is a fee rather than an open-ended hourly exercise. We will not characterise what other providers charge, because unpublished commercial terms cannot be verified. Ask, and get it in the contract. Our guide to changing your EU authorized representative sets out the sequence.
EU AR vs setting up an EU legal entity: full cost comparison
The honest comparison is a list of cost categories, not a spreadsheet of invented numbers. Incorporation, registered office, accountancy, audit and regulatory salary costs vary substantially by Member State and by company form. We do not publish those figures and will not estimate them: get a local quote in the specific Member State you are considering. The only hard number below is our own published authorised representative fee.
| Cost category you must budget for | Appointing an EU authorised representative | Setting up your own EU legal entity |
|---|---|---|
| Annual regulatory fee | EUR 800 to EUR 2,000 per year by class; setup EUR 0 (our published rates) | Replaced by the categories below |
| Incorporation and registered office | None | Varies by Member State; quote locally |
| Accountancy, audit and annual filings | None | Varies by Member State; quote locally |
| Corporate tax registration and compliance | None | Varies by Member State; quote locally |
| Regulatory personnel | Included in the mandate fee | Varies by Member State and role; quote locally |
| PRRC capacity under Art. 15(6) | Provided by the representative | You resource it; rules in MDCG 2019-07 Rev.1 |
| EUDAMED registration and upkeep | Handled under the mandate | Your entity registers and maintains its records |
| Time to operational | Mandate accepted in writing (MDR Art. 11(2)) | Formation plus staffing; varies locally |
| Exit or wind-down | EUR 150 Article 12 handover (published) | Liquidation and deregistration; varies locally |
One structural point changes the whole calculation. Article 11(1) requires a sole authorised representative where the manufacturer has no registered place of business in a Member State. A sales or logistics subsidiary does not remove that obligation. Removing it means making an EU-established entity the legal manufacturer, and moving the conformity assessment, the DoC and any certificates into that entity's name. That is a regulatory project, not an incorporation.
Our pricing, in full
Here is our whole EU Authorized Representative cost structure, also on our pricing page. Figures are per year, exclude VAT, and are fixed for three years from signature.
| MDR class | Annual fee | IVDR class | Annual fee |
|---|---|---|---|
| Class I | EUR 800 to 1,000 | Class A | EUR 800 to 1,000 |
| Class IIa | EUR 1,000 to 1,300 | Class B | EUR 1,000 to 1,300 |
| Class IIb | EUR 1,200 to 1,600 | Class C | EUR 1,200 to 1,600 |
| Class III | EUR 1,500 to 2,000 | Class D | EUR 1,500 to 2,000 |
- Setup fee: EUR 0.
- Change of representative, the Article 12 handover: EUR 150.
- One mandate covers the EU and Türkiye.
- EUDAMED scope: one device equals one Basic UDI-DI. Unlimited UDI-DI variants under the same Basic UDI-DI are covered by the base fee, and the first ten UDI-DI entries are included.
Not in the fee: design, quality management systems, drafting technical documentation, importing, distributing and notified body functions remain your responsibility. Regulatory consultancy is quoted separately. We are not a law firm and do not give legal advice. For the boundary between roles, read EU authorized representative vs importer vs PRRC and the Article 15 PRRC requirements.
One factual note on establishment, because buyers ask. MDCG 2022-16 states the authorised representative must be established within the Union; the MDR itself imposes no requirement to sit in a particular Member State. The Commission's Notice to Stakeholders on the EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) supplies the rest of that rule: a manufacturer established outside both the EU and Türkiye designates a single authorised representative, in Turkey or in the Community, and reaches both markets with it. Medex is established in Türkiye, is registered in EUDAMED as an authorised representative under SRN TR-AR-000057550, also holds manufacturer registration TR-MF-000057496 and importer registration TR-IM-000056252, and operates an office in Gdańsk, Poland. Verify any provider's registration in the public EUDAMED actor database before you sign, including ours.
How to read an AR quotation without getting caught
Eight questions that expose the real EU Authorized Representative cost
Put every proposal through the same eight questions and the differences stop being cosmetic. Send them as a written list; a provider that will not answer in writing has told you something.
- Is the annual fee per mandate, per generic device group, or per device? MDR Art. 11(2) sets the group as minimum scope.
- What is the setup fee, and does a second generic device group trigger it again?
- How many UDI-DI entries are included, and what is the rate above that number?
- When is the technical documentation reviewed, and by whom?
- What is the response time for a competent authority request?
- How is vigilance support priced: included, capped or hourly? The Article 10(13) reporting duty stays with you whoever does the work.
- What is the exit fee, and what does the Article 12 handover include?
- What is the professional indemnity insurance limit, in writing, given Article 11(5)?
Then ask for the price to be held for a defined period, and check the provider's own EUDAMED registration rather than accepting a logo on a website. If you are still deciding whether you need the role, start from our EU authorized representative service page and MDR Article 11 explained; for the contract itself, the mandate agreement guide covers what Article 11(3) requires.
Sources and further reading
- Regulation (EU) 2017/745 (MDR), consolidated 10 January 2025 - Articles 10, 10a, 11, 12, 15, 31.
- MDCG 2022-16, Guidance on Authorised Representatives, October 2022 (no revision as of August 2026).
- MDCG 2019-07 Rev.1, Guidance on the Article 15 PRRC, December 2023.
- MDCG 2021-5 Rev.1 Appendix, EU REP symbol transition, June 2026.
- Commission Decision (EU) 2025/2371 on EUDAMED functionality, OJ 27 November 2025.
- Commission Implementing Decision (EU) 2026/1231 of 11 June 2026, OJ 17 June 2026.
- Medex published rate card, medexeurep.com/pricing, 20 August 2026.
Frequently asked questions
How much does an EU authorized representative cost per year?
Budget roughly EUR 800 to EUR 2,000 per year for one generic device group, rising with risk class. Our published rates run from EUR 800 to 1,000 for MDR Class I or IVDR Class A up to EUR 1,500 to 2,000 for Class III or Class D, excluding VAT and fixed for three years from signature. Setup is EUR 0. What you pay depends on EUDAMED entries and how many groups you span.
Is there a per-device fee or a flat fee?
It depends on the provider, and this is the biggest source of confusion in EU authorised representative fees. Legally the unit is the generic device group: a designation is effective at least for all devices of the same group (MDR Art. 11(2)). Our fee is class-based; for EUDAMED one device equals one Basic UDI-DI, with unlimited variants under it covered by the base fee. Always ask which unit a quotation uses.
Do I pay extra for EUDAMED registration?
Not with us, within the published scope. The first ten UDI-DI entries are included in the base fee, and unlimited UDI-DI variants under the same Basic UDI-DI are covered. Beyond that, ask for the rate before you sign. This matters more since 28 May 2026, when the first four EUDAMED modules became mandatory under Commission Decision (EU) 2025/2371.
Why do some providers quote under EUR 500?
We cannot speak to how another firm builds its price, and a low number is not evidence of anything wrong. What we can say is that the Article 11(3) duties do not shrink with the fee, nor does the Article 15(6) obligation to keep a PRRC permanently and continuously available, nor the 10-year retention period. Ask what a sub-EUR 500 figure covers: setup, EUDAMED entries, document review, vigilance support and the exit fee.
Are exit or transfer fees normal?
Yes. A handover fee is a normal commercial term, because Article 12 requires a defined agreement between you, the outgoing representative where practicable, and the incoming one, covering termination dates, document transfer and continued forwarding of complaints. That is genuine work, and ours is EUR 150. We will not assert what others charge, because unpublished terms cannot be verified. Get the number into the contract before you sign.
Does the price change if I add a new device?
Sometimes. The rule to check is whether the new device falls inside a generic device group your mandate already covers. Under our published terms, additional UDI-DI variants under an existing Basic UDI-DI are covered by the base fee, and the first ten entries are included. A device in a new group at a higher class is a scope change. Our rates are fixed for three years from signature, so adding devices does not reprice existing ones.
Get a fixed-price EU REP quote (reply within 1 business day). Send your device list and class and we will return a written proposal against the published rates above, with the EUDAMED entry count and the Article 12 exit fee on the same page. Contact our regulatory team or email regulatory@medexeurep.com.