If you are an overseas manufacturer with devices on the Great Britain market, or planning to enter it, February 2026 brought news worth paying attention to. The MHRA launched a public consultation on the indefinite recognition of CE-marked medical devices in GB, open until 10 April 2026. If the proposals go through as currently outlined, the long-term compliance picture could look quite different from what many have been planning around.
But the consultation does not touch one requirement that is not going away. If you are based outside the UK and want to sell medical devices in Great Britain, you need a UK Responsible Person. Full stop. I have written separately about the CE marking consultation and what it actually changes. This blog is about the UKRP itself.
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What is a UK Responsible Person?
The UKRP is a legal entity based in the United Kingdom, appointed by a non-UK manufacturer to act on their behalf for the GB market. The role was created after Brexit, when non-UK manufacturers could no longer rely on their EU Authorised Representative to cover Great Britain. In functional terms, the UKRP is the GB equivalent of that EU AR role, defined under the UK Medical Devices Regulations 2002 as amended.
One point worth being precise about: Northern Ireland is not Great Britain. Under the Windsor Framework, Northern Ireland continues to follow EU rules. A device sold in Northern Ireland requires an EU or NI Authorised Representative, not a UKRP. If you are selling in both GB and Northern Ireland, you need both. The two roles are not interchangeable and one does not cover the other’s territory.
This catches more manufacturers out than it should, usually because the term ‘UK’ implies a single regulatory territory. It is not. Great Britain and Northern Ireland operate under different frameworks, and an appointment that covers one does not cover the other. I have spoken with manufacturers who assumed their UK distributor was handling everything, only to find the Northern Ireland position had never been addressed at all.
Who Needs a UKRP?
Any manufacturer based outside the UK placing medical devices on the GB market needs a UKRP before those devices are registered with the MHRA. Registration must happen before the device is placed on the market, not after. The MHRA will not accept registration from a non-UK manufacturer directly: the UKRP registers on the manufacturer’s behalf via DORS, the MHRA’s Device Online Registration System.
If your manufacturing base is in the UK, you register directly and do not need a UKRP. If you have a UK importer or distributor, they can in some circumstances take on the UKRP role. My strong recommendation is to keep the two separate unless you have a robust, long-term contractual arrangement in place. When the commercial relationship changes, and it often does, the regulatory obligations do not disappear with it. Manufacturers who have tied their UKRP appointment to a distributor relationship have found themselves scrambling to find a replacement mid-process, sometimes with devices already on the market. It is an avoidable situation.
What Does a UKRP Actually Do?
Perhaps a tad more than many manufacturers realise until it is too late. If there’s one mistake I saw repeatedly, it was manufacturers treating the EU AR as a postal address rather than a regulatory partner. Practical involvement only became visible at audit or when something went wrong. By that point the gaps were considerably harder to close. The UKRP role carries exactly the same risk of being treated as a formality, with exactly the same consequences.
The UKRP registers devices with the MHRA via DORS before they are placed on the market. On fees: until 31 March 2026 a one-off registration fee of £261 applies. From 1 April 2026, the MHRA moves to an annual fee model based on GMDN Level 2 categories, estimated at around £300 per category per year. If your portfolio spans multiple categories, factor that change into your budget now rather than when the invoice arrives.
Beyond registration, the UKRP must verify that the declaration of conformity and technical documentation have been drawn up and that the appropriate conformity assessment has been carried out. They keep documentation available for MHRA inspection and must respond to MHRA requests for information. Serious incident reporting, post-market surveillance, and cooperation with field safety corrective actions all sit within the UKRP’s ongoing remit.
There is also a termination obligation. If a manufacturer breaches their regulatory obligations, the UKRP must terminate the agreement and notify the MHRA and any relevant Approved Body. That is not a ceremonial clause. It is a real legal responsibility, and it is one reason why choosing a UKRP on price alone is a false economy.
How to Choose a UKRP Provider
The range in quality among UKRP providers, like any service, is considerable. At one end are specialist regulatory consultancies with genuine technical depth. At the other are administrative agencies that can file paperwork but cannot meaningfully engage with what they are filing. The difference matters most when the MHRA comes asking questions.
Ask directly about their experience with the device classes and regulatory routes relevant to your product. How do they handle serious incident reports? Who specifically is responsible for your account day to day, and what happens if that person leaves or is absent for any period of time? Any provider worth appointing should answer those questions without hesitation. If they cannot, that tells you something.
It is also worth keeping an eye on the wider regulatory context. The qualification requirements for the EU’s equivalent role, the Person Responsible for Regulatory Compliance, are currently proposed for removal under COM(2025) 1023. The UK framework has its own requirements, but the direction of travel in some quarters is towards lighter-touch oversight of who can fulfil these roles. That makes genuine expertise more important, not less. When formal qualification bars are being debated away, a provider’s track record and technical depth are what you are really buying.
On contracts: a formal letter of designation is required by the MHRA, but from working with EU AR and virtual manufacturer arrangements I found the most effective setups went further. The formal agreement was supplemented by a plain-English statement of works, a document setting out in practical terms how the relationship would actually operate: who does what, how issues are escalated, what the response time expectations are. It sounds like extra work. When an audit or incident arrives and everyone is under pressure, that clarity is worth considerably more than the few hours it took to produce.
In audits I conducted, manufacturers would often be asked to produce their AR agreement and either could not find it or discovered it said very little of practical use. That is not a position you want to be in with a UKRP either.
UKRP Appointment Checklist
Before appointing a UKRP, work through the following:
- Confirm the provider has specific experience with your device class and regulatory route, not just general regulatory knowledge.
- Establish who will be your named contact and what their qualifications are. Ask what happens to your account if that person leaves.
- Confirm the formal letter of designation covers scope, responsibilities, termination provisions, and notification obligations to the MHRA.
- Agree a plain-English statement of works alongside the formal agreement, setting out how the relationship will operate day to day.
- Clarify their process for serious incident reporting and post-market surveillance. These are live obligations, not annual tasks.
- If you are also selling in Northern Ireland, confirm that your EU or NI AR appointment is separate and current. The UKRP does not cover NI.
Does the CE Marking Consultation Change Any of This?
No, not really. The MHRA’s February 2026 consultation proposes three things: aligning the GB transitional period for EU MDD-certified devices with the EU timeline to 31 December 2028; indefinite recognition of CE-marked devices compliant with the EU MDR or IVDR; and an international reliance route for devices that fall into a higher risk class under UK rules than EU rules.
The second proposal is the significant one. If adopted, manufacturers with current CE marking under the EU MDR would not need separate UKCA certification for the GB market. For companies running dual compliance strategies, that matters.
What it does not remove: the UKRP requirement, MHRA registration, or ongoing post-market surveillance obligations under UK rules. Around 901 per cent of devices on the GB market are currently CE-marked. The MHRA has been clear that regulatory oversight of those devices continues. The consultation simplifies part of the compliance picture. It does not clear it.
The consultation closes on 10 April 2026. The statutory instrument to implement any changes still needs to be laid, and the final text may look different from what is currently proposed. Plan around the proposals, but build in flexibility. I have written about the consultation and its implications in more detail separately, and that piece is worth reading alongside this one. Read here.
How Peritus Can Help
The GB market involves more moving parts than it might initially appear, and the regulatory landscape is spinning like plates at the moment. Whether you are trying to understand what the CE marking consultation means for your specific product portfolio, reviewing your current UKRP arrangements, or working through what MHRA registration actually requires, I am happy to talk it through.
Get in touch for an initial conversation.