EU Authorized Representative for UK Manufacturers: Great Britain, Northern Ireland, EU
British manufacturers already understand the EU Authorized Representative role, because they have spent years appointing UK Responsible Persons for their own overseas suppliers. What changes after Brexit is the direction of travel: a registered place of business in Great Britain now sits outside the Union, so the obligation runs the other way. Northern Ireland complicates it further, because under the Windsor Framework it is an MDR and IVDR market with a UK postcode. This page sets out Great Britain, Northern Ireland and the Union as three distinct placings, and what each one asks of you.
Great Britain, Northern Ireland and the Union are three separate placings
A device leaving a plant in Cambridge, Livingston or Leeds can be put on three markets, and British teams regularly find the three sit on three different instruments. Great Britain runs on the Medical Devices Regulations 2002, which give effect in UK law to Directives 90/385/EEC, 93/42/EEC and 98/79/EC — the directive generation. Northern Ireland runs on Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The Union runs on those same two Regulations, plus one consequence for anybody whose registered place of business is in Sheffield rather than Stockholm.
The MHRA is blunt about the marks not travelling: the UKCA marking is not recognised in the EU, EEA or Northern Ireland markets.
| Great Britain | Northern Ireland | EU / EEA | |
|---|---|---|---|
| Governing instrument | UK MDR 2002, derived from AIMDD, MDD and IVDD | MDR 2017/745 and IVDR 2017/746, applied under the Windsor Framework | MDR 2017/745 and IVDR 2017/746 |
| Marking | UKCA, or CE within the acceptance timelines below | CE; combined CE and UK(NI) where a UK notified body carried out the assessment | CE |
| Representative a GB-established manufacturer needs | None — you are established in the UK | A sole authorised representative established in the EU or Northern Ireland | A sole authorised representative established in a Member State |
| Who registers, and where | Manufacturer, or the UK Responsible Person for a non-UK manufacturer, with the MHRA | Economic operators register as actors in EUDAMED; custom-made devices stay on DORS | Economic operators register as actors in EUDAMED and obtain an SRN |
The UK Responsible Person, read from the other side
Anyone who has appointed a UK Responsible Person, or acted as one, already knows the shape of what the Union asks. The UKRP verifies that the declaration of conformity and technical documentation have been drawn up, keeps a copy available for the MHRA, registers the devices before they reach the GB market, forwards complaints and cooperates on corrective action. Read that list, change the flag, and you have the Article 11 mandate.
MDR states the trigger in one sentence: "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." (MDR Art. 11(1)) A British registered place of business is now outside a Member State, so a UK manufacturer selling into the Union is in exactly the position its overseas suppliers are in when they appoint a UKRP.
The MHRA says the same thing in its own guidance: "If you are a manufacturer based in Great Britain or another country outside the EU, you must appoint an authorised representative based in the EU or Northern Ireland if you wish to supply devices to the EU market." (MHRA, Regulating medical devices in the UK)
Northern Ireland: an EU placing with a UK postcode
This is the part that catches out companies who assume Belfast is a domestic sale. Under the Windsor Framework, MDR has applied in Northern Ireland since 26 May 2021 and IVDR since 26 May 2022. Supplying a Belfast trust is a placing under EU law, assessed against Annex I general safety and performance requirements, with EUDAMED actor registration and EU vigilance behind it.
The MHRA is specific about who must be appointed: a Great Britain-based manufacturer supplying Northern Ireland needs a sole authorised representative based in the EU or Northern Ireland. One mandate can cover Northern Ireland and the twenty-seven Member States together, which is usually the sensible way to set it up.
How long CE marking still works in Great Britain, and what that date does not buy
The government has extended acceptance of CE-marked devices in Great Britain on three separate clocks, commonly misquoted, so here they are as the MHRA sets them out. Devices compliant with the MDD or AIMDD may be placed on the GB market up until the sooner of expiry of certificate or 30 June 2028. IVDs compliant with the IVDD may be placed up until the sooner of expiry of certificate or 30 June 2030. Devices compliant with EU MDR, and IVDs compliant with EU IVDR, may be placed up until 30 June 2030. The government has also announced that it will consult on indefinite recognition of CE-marked medical devices.
None of those dates is a Union date. They govern how long Great Britain will keep taking a CE mark. Whether your certificate still lets you sell in the Union is decided by MDR Article 120, which runs to 31 December 2027 for class III and class IIb implantable devices and 31 December 2028 for other class IIb, class IIa and class I sterile or measuring devices — and only where the manufacturer had a compliant quality management system in place by 26 May 2024, lodged an application with a notified body by the same date and signed a written agreement with it by 26 September 2024. A company reassured by 2030 in Britain can be out of the Union market years earlier.
A UK approved body certificate is not a notified body certificate
UK notified bodies had their MHRA designations rolled over and became UK approved bodies, assessing against UK MDR 2002 for the GB market. That is a directive-era assessment. An MDR conformity assessment is a different exercise: clinical evaluation under Annex XIV with a post-market clinical follow-up plan, an Annex IX quality management system audit, technical documentation structured to Annexes II and III, and unannounced audits. A UKCA file is a genuine head start on the evidence, but it is not a substitute for the certificate.
For portfolios that were self-declared class I under the directives the consequence is sharper still: reusable surgical instruments, many software products and a long list of upclassified devices now need a notified body they never previously needed.
Mandate, SRN and the second address on the label
The designation only works when it is accepted in writing, and Article 11 does not let it be a nameplate. The representative verifies the declaration of conformity and technical documentation, keeps them available, carries the registration obligations in Article 31, answers competent authorities in the official Union language they nominate, and terminates the mandate if the manufacturer acts contrary to the Regulation. It also carries risk: "Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer." (MDR Art. 11(5))
The label changes too. Annex I requires "if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;" (MDR Annex I, Section 23.2(d)) — alongside, not instead of, the UK Responsible Person details your GB artwork already carries where UKCA marking has been affixed. Our EU Authorized Representative service covers the mandate and the EUDAMED registration that follows it.
What British regulatory teams ask about the EU side
Can our UK Responsible Person also be our EU Authorized Representative?
Not if they are established in Great Britain. The MHRA is unambiguous: "Great Britain-based authorised representatives are no longer recognised in the EU. This means that they are not able to carry out tasks on the manufacturer’s behalf for the purposes of placing devices on the EU market." (MHRA) Article 11(1) is a territorial test, so most UK manufacturers end up holding a UKRP and an EU representative side by side.
We sell to Northern Ireland but not to the rest of the EU. Do we still need one?
Yes. Northern Ireland is an MDR and IVDR market under the Windsor Framework, so a Great Britain manufacturer placing devices there needs a sole authorised representative in the EU or Northern Ireland, EUDAMED actor registration and an SRN. One mandate should cover the whole Union so you do not maintain two versions of one technical file.
Our notified body became a UK approved body. Is our old certificate still good in Europe?
A UK approved body designation is for the Great Britain market under UK MDR 2002. Where certificates were not transferred to an EU notified body, the UK body continues to oversee them for GB purposes only. For the Union you need a certificate from a notified body designated under MDR.
Does the 30 June 2030 date in Great Britain give us breathing room in the EU?
No, and it is the most expensive misreading we see. The GB timelines say how long the UK will accept a CE mark. They have no effect on MDR Article 120, on the validity of your certificate in the Union, or on the date a notified body agreement had to be signed.