---
title: Local Representatives and In-Country Agents by Market
description: Local representative medical device international guide: EU AR, US Agent, CH-REP, UKRP roles, contract essentials, single vs multi-market firms.
authors: Tibor Zechmeister, Felix Lenhard
category: FDA & International Market Access
primary_keyword: local representative medical device international
canonical_url: https://zechmeister-solutions.com/en/blog/local-representatives-by-market
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# Local Representatives and In-Country Agents by Market

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **Non-EU manufacturers must designate an EU Authorised Representative under MDR Article 11. Switzerland requires a CH-REP, the UK requires a UK Responsible Person, and the US requires a US Agent for FDA purposes. Each role has different responsibilities, liabilities and contractual defaults. And founders routinely underestimate how different they really are.**

**By Tibor Zechmeister and Felix Lenhard.**

## TL;DR
- MDR Article 11 requires non-EU manufacturers to designate a single EU Authorised Representative with a written mandate covering specific legal responsibilities.
- The CH-REP (Switzerland), UKRP (United Kingdom), and US Agent (FDA) are distinct roles with different legal scope, responsibilities, and liability exposure.
- An EU AR is a legal representative for regulatory purposes. Not a distributor, not a sales agent, not an importer.
- Contractual essentials include scope of mandate, liability caps, data access, notice periods, termination rights, and cost structure.
- Single-firm multi-market solutions reduce coordination overhead but can concentrate risk and limit local expertise in each market.
- Retainer costs typically range from EUR 3,000 to EUR 18,000 per market per year, with higher fees for higher risk classes and higher volumes.

## Why this matters

I watched a founder nearly lose CE mark access because the authorised representative contract had been signed three years earlier by a predecessor CEO, the original mandate had been too narrowly drafted, and the AR was refusing to pass vigilance reports to the competent authority in a timeline that matched MDR obligations. The notified body noticed during surveillance. The fix took four months and a six-figure legal bill.

This story is not rare. The authorised representative is one of the few actors in the MDR ecosystem where the contract you sign directly determines your regulatory standing. Get it wrong and you have a legal problem that cannot be solved by a better technical file. Get it right and the AR becomes a genuine safety net.

The same discipline applies to the CH-REP, UKRP and US Agent. Different markets, different rules, same core principle: the local representative is a legal position, not a logistics contact.

## What MDR actually says

**MDR Article 11** ("Authorised representative") establishes that, where the manufacturer of a device is not established in a member state, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. The designation constitutes the authorised representative's mandate, is valid only when accepted in writing by the authorised representative, and is effective at least for all devices of the same generic device group.

The mandate must require, and the authorised representative must perform, at least the following tasks in relation to the devices covered:

- Verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, at the disposal of competent authorities.
- Comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29.
- In response to a request from a competent authority, provide that authority with all the information and documentation necessary to demonstrate conformity of a device.
- Forward to the manufacturer any request by a competent authority of the member state in which the authorised representative has its registered place of business for samples, or access to a device.
- Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- Terminate the mandate if the manufacturer acts contrary to its obligations under the MDR.

Article 11 also establishes joint and several liability of the AR with the manufacturer for defective devices, in specific circumstances set out in the article.

**Switzerland: CH-REP.** Switzerland is outside the EU and outside the Mutual Recognition Agreement for medical devices since 2021. Non-Swiss manufacturers placing devices on the Swiss market must appoint a CH-REP under the Swiss Medical Devices Ordinance (MedDO). Role scope is similar to the EU AR but is a separate legal designation.

**United Kingdom: UK Responsible Person (UKRP).** Since Brexit, non-UK manufacturers must designate a UKRP established in the UK, with responsibilities broadly mirroring those of an EU AR, registered with MHRA.

**United States: FDA US Agent.** A US Agent under FDA regulations acts as a point of contact for FDA communication. The US Agent's scope is narrower than an EU AR. They are primarily a communication and import point of contact, not a holder of technical documentation or a party to conformity assessment.

These are not interchangeable roles. A single firm may offer all four services, but the underlying legal basis and responsibilities differ significantly.

## A worked example

A Swiss Class IIb device manufacturer wants to sell into the EU, maintain Swiss market access, enter the UK, and prepare for FDA 510(k) clearance. The company needs:

- **EU AR** under MDR Article 11. Mandate covering all generic device groups currently CE-marked. Retainer quote: EUR 9,000 per year, with annual review. Responsibilities include EUDAMED registration support, vigilance forwarding, and competent authority interface.
- **CH-REP** registered with Swissmedic. As the manufacturer is Swiss, this role is not strictly required in the same way. But the manufacturer still needs to comply with Swiss registration and labelling obligations domestically.
- **UKRP** established in the UK, registered with MHRA. Retainer: EUR 6,000 per year. Responsibilities include MHRA registration, vigilance coordination with the MHRA Yellow Card system, and point of contact for MHRA queries.
- **US Agent** once 510(k) is submitted. Retainer: EUR 2,000 to EUR 4,000 per year. Role is narrower. Primarily FDA communication and facility registration contact.

Total annual commitment: approximately EUR 17,000 to EUR 21,000 across four representative roles, plus per-submission fees for vigilance events and renewal updates. The manufacturer negotiated 12-month initial terms with all four, wrote clear termination-for-convenience clauses into every contract, and structured them so that a single internal RA manager could coordinate all four via standardised templates.

The contracts were not identical, because the legal scope differs across markets. But the coordination layer on the manufacturer's side was unified. This is the pattern that works.

## The Subtract to Ship playbook

**Step 1: Start from the mandate, not the retainer.** The first question is not "how much does this cost". It is "what are we asking this representative to do, and does the written mandate reflect that exactly?" Draft the mandate scope internally first, then compare it against what each candidate AR is willing to sign up to.

**Step 2: Insist on contractual essentials.** Every representative contract should clearly address: scope of mandate, devices covered, liability caps, data access rights (the manufacturer must have unrestricted access to all communications with authorities), notice period for termination (12 months maximum), obligations on transition (data handover, mandate transfer), cost structure (fixed retainer plus clearly defined extras, not open-ended hourly billing), and confidentiality.

**Step 3: Check the representative's standing.** Is the EU AR actually established in an EU member state and registered with EUDAMED? Is the UKRP on the MHRA list? Is the CH-REP recognised by Swissmedic? A representative who cannot produce their own registration documentation on request is a red flag.

**Step 4: Decide single-firm versus specialist per market.** A single firm serving EU, UK, CH and US offers simplicity but concentrates risk. If that firm has a service disruption, all four markets are affected simultaneously. A specialist per market offers resilience and deeper local knowledge but more coordination cost. For most startups entering fewer than five markets, specialists per market deliver better quality. Above five markets, hybrid models start to make sense.

**Step 5: Build a representative oversight cadence.** Quarterly review of communications with authorities, annual audit of the representative's own QMS (yes, this is reasonable and you should ask), and documented review of whether the mandate still reflects your current device portfolio. The mandate drifts as your portfolio grows.

**Step 6: Plan exit before you sign.** What happens if you need to change representatives? Who owns the historical data? What notice period applies? Who notifies the competent authority? Write this into the contract upfront. An AR who resists clean exit terms is telling you something about their commercial model.

## Reality Check

1. Do you have a current written mandate with your EU AR covering all generic device groups you market under the CE certificate?
2. Is your EU AR properly registered in EUDAMED with an SRN, and have you verified this independently?
3. For each non-EU market you serve, have you identified the legal representative role required and signed a corresponding contract?
4. Do your representative contracts have notice periods of 12 months or less, with clean exit terms?
5. Have you documented what happens to historical regulatory data if a representative contract is terminated?
6. Do you receive regular (at least quarterly) reports from each representative on communications with authorities?
7. Have you modelled the total annual cost of all your representative relationships in your 3-year budget?
8. Is there a single internal owner who coordinates across all representative relationships, or is this spread across functions?

## Frequently Asked Questions

**Can a non-EU manufacturer have more than one EU Authorised Representative?**
MDR Article 11 requires a single authorised representative per generic device group. A manufacturer can have different ARs for different generic device groups, but not parallel ARs for the same devices.

**Is an EU AR the same thing as an importer or distributor?**
No. The EU AR is a legal representative of the manufacturer for regulatory purposes under MDR Article 11. Importers and distributors have separate obligations under MDR Articles 13 and 14. The same legal entity can in principle hold more than one role, but the roles and liabilities are distinct.

**How much should an EU AR cost per year for a Class IIa device family?**
Typical retainers range from approximately EUR 4,000 to EUR 12,000 per year for a Class IIa single device family, depending on device complexity, number of variants, vigilance volume, and the AR's location and market standing.

**Can I use the same firm for EU AR, UKRP, CH-REP and US Agent?**
Yes, several firms offer all four services. The practical question is whether consolidation offers better value than specialists in each market, and whether you are comfortable with the concentration of risk that comes with a single counterparty.

**What happens if I do not designate an EU AR but ship into the EU?**
The device is not legally placed on the Union market under MDR Article 11. This creates exposure for the manufacturer, importer and distributor, and is a direct non-conformity in any market surveillance action.

**Can an AR refuse to act on a vigilance event?**
Under MDR Article 11, the AR has specific obligations including immediate forwarding of suspected incident reports to the manufacturer and cooperation with competent authorities. An AR that refuses these duties is in breach of its mandate, and you should terminate the relationship and report the matter appropriately.

## Related reading
- [Authorised representatives under MDR](/blog/authorized-representatives) – the full MDR Article 11 deep dive.
- [Country-specific registration costs](/blog/country-specific-registration-hidden-costs) – budgeting the total representative stack across markets.
- [US Agent for FDA for EU startups](/blog/us-agent-fda-eu-startups) – the narrower US role explained.
- [UK MHRA and UKCA marking](/blog/uk-mhra-ukca-marking-2026) – the UK regulatory landscape including UKRP.
- [International expansion sequencing](/blog/international-expansion-sequencing) – when to add each representative to the stack.

## Sources
1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 11, 13, 14, 27, 29, 31.
2. Swiss Medical Devices Ordinance (MedDO). CH-REP obligations.
3. UK Medical Devices Regulations 2002 (as amended). UKRP obligations.
4. US FDA, 21 CFR Part 807. Establishment registration and US Agent.

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*This post is part of the [FDA & International Market Access](https://zechmeister-solutions.com/en/blog/category/fda-international) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*