EU Authorised Representative, UK Responsible Person, Swiss CH-REP: Three Appointments, Not One
Updated: Aug 15
A manufacturer outside Europe used to solve Europe with one CE certificate and one representative. That arrangement ended in stages. The United Kingdom left the CE regime for Great Britain, Switzerland lost its mutual recognition chapter, and the MDR tightened what a representative is for. There are now three appointments, each with its own establishment requirement, and only one of them can be satisfied from outside the country concerned.
The European Union: Article 11
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 mandate; it is valid only when accepted in writing by the representative and is effective at least for all devices of the same generic device group.
Article 11(3) sets the minimum task list: verifying that the declaration of conformity and technical documentation have been drawn up, keeping a copy available for competent authorities, complying with the registration obligations in Article 31 and verifying the manufacturer's own under Articles 27 and 29, answering competent authority requests in an official Union language, forwarding sample and access requests, cooperating on preventive and corrective action, immediately informing the manufacturer of complaints and suspected incident reports, and terminating the mandate if the manufacturer acts contrary to its obligations.
Article 11(4) makes clear what a mandate cannot move: the obligations in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12) stay with the manufacturer. The IVDR's equivalent list is different, being Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11), so a mandate drafted for MDR devices and reused for IVDs is citing the wrong paragraphs.
Article 11(5) is the provision that determines how a serious representative behaves. 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.
Actor registration under Article 31 produces the Single Registration Number, issued through EUDAMED by the competent authority rather than by the Commission. Since 28 May 2026 the actor registration, UDI and device registration, notified bodies and certificates, and market surveillance modules have been mandatory, under Commission Decision (EU) 2025/2371.
Great Britain: the UK Responsible Person
The requirement sits in the Medical Devices Regulations 2002 as amended, and not where most summaries put it. For general medical devices it is regulation 7A. For active implantable devices, regulation 21A. For in vitro diagnostics, regulation 33A. Regulation 21C, the old standalone active implantable provision, was omitted with effect from 21 March 2024.
Regulation 7A(1) opens by providing that no person may place a relevant device on the market in accordance with that Part unless that person is established in Great Britain and has complied with paragraph (2). Where the manufacturer is based outside the United Kingdom, paragraph (2) requires the manufacturer to appoint a sole UK Responsible Person, who must give the Secretary of State written evidence of authority to act.
The definition in regulation 2 says a UK Responsible Person is established in any part of the United Kingdom, while regulation 7A(1)(a) requires establishment in Great Britain of the person placing the device on the market. The two are worth keeping distinct rather than flattening into one sentence.
The task list mirrors the EU one in substance: verify the declaration of conformity and technical documentation, keep them available for the Secretary of State, provide information on request, provide samples or access or forward the request, cooperate on preventive and corrective action, inform the manufacturer of complaints and suspected incidents, and terminate if the manufacturer acts contrary to its obligations. Registration is through the MHRA's Device Online Registration System.
The liability position is stated differently from the EU's. Regulation 60(3) provides that a UK Responsible Person may be proceeded against as a person placing the device on the market and, in relation to supply within the United Kingdom after placing on the market, as a person supplying it. That is an enforcement exposure rather than the MDR's civil joint and several liability, but it is not a lighter one to hold.
The dates that matter in Great Britain
CE marking acceptance in Great Britain is governed by regulation 1ZA of the 2002 Regulations, substituted by the Medical Devices (Amendment) (Great Britain) Regulations 2023. Devices certified under the old Directives, MDD 93/42 and AIMDD 90/385, may be placed on the GB market until the sooner of certificate expiry or 30 June 2028. Devices certified under the MDR, and devices under the IVDD and the IVDR, run to 30 June 2030.
Post-market surveillance came first in the reform sequence. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, SI 2024/1368, were made on 16 December 2024 and came into force six months later, on 16 June 2025.
The pre-market regulations have not followed yet. The MHRA published a draft instrument, referred to as the Medical Devices (Amendment) Regulations 2026, on the WTO notification portal on 8 May 2026 and ran a stakeholder impact survey from 11 May to 19 June 2026. As of August 2026 it is a published draft: not laid, not made, not in force. One provision in it is already worth planning for, because the draft would require the UK Responsible Person to have a physical presence in the United Kingdom, described by the MHRA as a tangible location rather than a virtual office.
Northern Ireland is not Great Britain
The MDR has applied in Northern Ireland since 26 May 2021 and the IVDR since 26 May 2022, with the MHRA as competent authority. The representative required for the Northern Ireland market is an authorised representative based in the EU or Northern Ireland, not a UK Responsible Person. MHRA guidance contains no UKRP requirement for Northern Ireland at all, and since 28 May 2026 non-custom-made devices for the Northern Ireland market are registered in EUDAMED rather than with the MHRA.
Devices assessed by a UK notified body carry the combined CE and UK(NI) marking. They may be placed across the whole UK market but are not accepted on the EU market. Under the Windsor Framework, qualifying Northern Ireland goods meeting EU requirements move to Great Britain without additional barriers.
Switzerland: the CH-REP
Article 51 of the Medical Devices Ordinance is unusually direct about its own borrowing. Where the manufacturer is not domiciled in Switzerland, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in Switzerland by written mandate. The representative is responsible for the formal and safety-related aspects of placing the device on the market. And then, in paragraphs 3 and 4: the representative's rights and obligations and the scope of the mandate are governed by Article 11 of the EU MDR, and changes of representative by Article 12.
Switzerland did not write its own task list. It imported the MDR's. Article 52 adds the requirement for a person responsible for regulatory compliance permanently and continuously at the representative's disposal. The IVD Ordinance mirrors both at Articles 44 and 45.
The transition deadlines are long past. Article 104a of the Medical Devices Ordinance, inserted by the amendment of 19 May 2021, required manufacturers domiciled in an EU or EEA state to designate a CH-REP by 31 December 2021 for class III devices, implantable class IIb devices and active implantable devices; by 31 March 2022 for non-implantable class IIb and class IIa devices; and by 31 July 2022 for class I devices and for systems and procedure packs. Manufacturers from other third countries never had that window. Under Article 86 of the IVD Ordinance the IVD dates were 31 December 2022 for class D, 31 March 2023 for classes B and C, and 31 July 2023 for class A.
The CH-REP's name and address must appear on the label, packaging or instructions for use. Article 16(1) of the Medical Devices Ordinance applies Chapter III of Annex I to the EU MDR, and Swissmedic accepts the symbol with the name and address adjacent, or the wording CH-REP, CH authorised representative, or Authorised representative for Switzerland. Product information must be in all three official languages.
The reason all of this exists is that Chapter 4 of the EU-Switzerland Mutual Recognition Agreement was never updated for the MDR. Switzerland has been treated as a third country for medical devices since May 2021 and for IVDs since May 2022, and Swissmedic's access to the European database was withdrawn. The Switzerland-EU package signed on 2 March 2026 does contain an amending protocol to that agreement, and the Federal Council adopted its dispatch to Parliament on 13 March 2026, but it is not in force. A CH-REP is mandatory today.
What can be combined, and what cannot
The establishment requirements settle most of the question. The EU representative must be in a Member State. The UK Responsible Person must be in the United Kingdom, and the person placing devices on the Great Britain market must be established in Great Britain. The CH-REP must be domiciled in Switzerland. No single legal entity satisfies all three. What is common in practice is one corporate group holding separate entities in each jurisdiction, which is a commercial arrangement rather than a regulatory shortcut.
There is one genuine exception, and it runs the other way. Under the EU-Türkiye Customs Union, through Association Council Decisions No 1/95, 2/97 and 1/2006 together with the Customs Union Joint Committee statements of 21 May and 13 September 2021 confirming Türkiye's alignment with the MDR and IVDR, the European Commission's own notice states that manufacturers established in Türkiye have no obligation to designate an authorised representative in the EU, and that a third-country manufacturer needs only one authorised representative, either in the EU or in Türkiye. Certificates issued by Turkish notified bodies circulate freely in the EU on the same footing.
That position rests on the Customs Union instruments as applied by the Commission and confirmed by TITCK, not on an amendment to Article 11, whose text still refers to a Member State. It is the reason a Türkiye-established representative works for the EU market and a UK-established one does not. There is a customs union in the first case and no equivalent instrument in the second.
Sources
Regulation (EU) 2017/745, Articles 11, 12 and 31; Regulation (EU) 2017/746, Articles 11, 12 and 28
Commission Decision (EU) 2025/2371 of 26 November 2025 on the functionality of certain EUDAMED electronic systems
MDCG 2021-13, Questions and answers on obligations and related rules for the registration in EUDAMED of actors
The Medical Devices Regulations 2002 (SI 2002/618) as amended, regulations 1ZA, 2, 7A, 21A, 33A and 60
The Medical Devices (Amendment) (Great Britain) Regulations 2023 (SI 2023/627)
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024/1368)
MHRA guidance: Regulating medical devices in the UK; Register medical devices to place on the market; Medical devices, EU regulations for MDR and IVDR
Medical Devices Ordinance (MedDO, SR 812.213), Articles 16, 51, 52 and 104a; IVD Ordinance (IvDO, SR 812.219), Articles 44, 45 and 86
Swissmedic, CH-REP page and information sheet MU600_00_016e on the obligations of economic operators
Swiss Federal Office of Public Health, medical devices legislation; Federal Department of Foreign Affairs, dispatch on the Switzerland-EU package, 13 March 2026
European Commission, EU-Turkey Customs Union Agreement in the field of medical devices, March 2022; TITCK announcement on mutual recognition of authorised representatives and notified bodies
Who wrote this
Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550, verifiable in the EUDAMED public actor database. We are not a law firm and do not provide legal advice.
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