UK Responsible Person requirements: the complete guide

UK Responsible Person requirements apply to every manufacturer based outside the UK that wants to place a medical device or in vitro diagnostic (IVD) on the Great Britain market: under regulation 7A of the UK Medical Devices Regulations 2002, and the parallel provisions for active implantables and IVDs, you must appoint a sole UK Responsible Person (UKRP) before the device goes on sale. Not after the first order ships. Before.

We cover who needs one, the eight statutory tasks, the letter of designation, registration with the Medicines and Healthcare products Regulatory Agency (MHRA), CE marked devices, Northern Ireland and what to check before you appoint anyone. It is current to 25 September 2026.

Do I need a UK Responsible Person to sell medical devices in the UK?

If your company is based outside the United Kingdom and you want to sell in England, Scotland or Wales, yes. Regulation 7A(2) says a manufacturer based outside the UK must appoint a sole UK Responsible Person, and that person must give the Secretary of State written evidence of its authority to act for you. In practice that evidence is the letter of designation the MHRA asks for at registration.

The requirement catches three kinds of company:

• A manufacturer outside the UK entering the Great Britain market for the first time.
• An established exporter that has sold into the UK for years through a distributor without ever formally appointing anyone to this role.
• A group that has restructured, spun out a new company or changed which legal entity is the manufacturer.

The second case is the one that catches people out. Trading history is not compliance. The appointment either exists on the registration or it does not.

The mark does not change the answer. A manufacturer outside the UK needs a UKRP whether the device carries a CE mark or a UKCA (UK Conformity Assessed) mark.

Having a distributor is not the same as having a UK Responsible Person

This comes up constantly: we already have a UK distributor, surely that covers it. It does not, unless you have formally appointed them. The MHRA says there is nothing to stop an importer or distributor also acting as your UK Responsible Person, but a distributor relationship on its own is not the appointment. A distributor sells your product. A UK Responsible Person is a formal regulatory appointment, made in writing, named on your MHRA registration and carrying the statutory tasks below. A sales relationship has never satisfied regulation 7A on its own.

What does a UK Responsible Person have to do?

Regulation 7A(3) lists the tasks, from (a) to (h). This is the list your UKRP signs up to, so read it before you read anyone’s sales material.

Statutory task under regulation 7A(3)	What it means in practice
Ensure the declaration of conformity and technical documentation have been drawn up and the conformity assessment carried out	Your UKRP has to see the file. One that has never opened it cannot confirm this.
Keep the technical documentation, declaration of conformity and certificates available for inspection	A current copy, held where it can be produced, not a promise to ask you for it.
Supply information on request	The UKRP answers the regulator, so it needs to understand the answers.
Supply samples or give access to the device	Someone has to be able to get product to the regulator.
Pass requests for samples or access on to the manufacturer	Where the UKRP cannot supply samples or access itself, it sends the request to you and then tells the regulator whether you will comply.
Cooperate on preventive or corrective action	Field safety work involves your UKRP, not just your own team.
Immediately inform the manufacturer of complaints and incident reports	Immediately is the word in the law. Ask how that works at a weekend.
Terminate the relationship and inform the Secretary of State, and the Approved Body where relevant, if the manufacturer breaches its obligations	Your UKRP is legally required to walk away if you do.

That last task surprises people. A UKRP that has not reviewed your file cannot responsibly hold the appointment, because the law expects it to end the relationship if something is wrong. A mailbox cannot meet that duty.

The Great Britain post market surveillance rules make the documentation duty sharper. They were added as Part 4A of the regulations, came into force on 16 June 2025 and apply to CE and UKCA marked devices alike. Any post market surveillance report has to be made available to the MHRA within three working days of a request. The MHRA, the UK Approved Body and the UKRP must also be told about field safety corrective actions in advance. Your UKRP needs the current version of your file, not last year’s.

What is a UK Responsible Person letter of designation?

It is the written evidence of authority that regulation 7A asks for, and the MHRA treats it seriously. The MHRA describes the letter of designation as a legal contract, stating that you are the exclusive UK Responsible Person.

Exclusive matters. The law asks for a sole UKRP. If a previous UKRP is still named anywhere, or two firms each believe they hold the role, fix that first.

The letter is also part of registration. The MHRA asks for it alongside the manufacturer’s details, so a letter that is missing, out of date or names the wrong legal entity undermines the registration.

In our experience a good letter covers:

• The exact legal manufacturer, as it appears on the label.
• The devices or ranges in scope.
• The regulation 7A tasks, including the duty to terminate and inform the regulator.
• How complaints and incident reports move between you, and how fast.
• What happens at the end: handover of documents, the label change and who tells whom.

How does the UK Responsible Person fit with MHRA registration?

Registration happens in the Device Online Registration System (DORS) and nowhere else. The MHRA is precise about when it counts: you are not regarded as registered until you have provided details of the device and received confirmation. Opening an account is not registering.

DORS asks for the legal entity name and address exactly as they appear on the label, up to 15 administrative contacts and the UKRP letter of designation. For each device it asks for the legislation, class, Global Medical Device Nomenclature (GMDN) code and term, the Basic UDI-DI (the main unique device identification key) if one applies, brand name, model, catalogue number, the UK Approved Body or EU Notified Body, and the certificates or declarations of conformity. Our guide to MHRA medical device registration takes each of these in turn.

The fee changed this year. For the 2026 to 2027 charging year the MHRA charges £300 for each Level 2 GMDN category you register, and it says the fee will change annually, or Level 1 where no Level 2 exists, under The Medical Devices (Fees Amendment) Regulations 2026, statutory instrument (SI) 2026/197. Several devices under one Level 2 category are charged once for that category. The charging period runs from 1 April to 31 March, and registrations made part way through are charged pro rata. Guides still quoting a flat £261 per application are out of date.

The label has to match the registration. Where the UKCA mark is affixed, including on devices that carry both the CE and UKCA marks, the UKRP’s name and address must appear on the labelling, the outer packaging or the instructions for use. CE marked only devices do not need UKRP details on the label. Where they are on it, changing your UKRP changes your labels, so build that into any plan to switch.

Once registered, the manufacturer appears on the Public Access Registration Database (PARD), with the UKRP shown inside the manufacturer’s record. The MHRA says it is not currently possible to search PARD by representative, so you cannot use it to see which other manufacturers a UKRP represents. Ask them. And registration is not approval. The MHRA states that it does not represent any form of accreditation, certification, approval or endorsement, and MHRA logos and such claims must not be used in marketing or packaging.

Do CE marked devices and Northern Ireland follow the same rules?

CE marked devices can still be placed on the Great Britain market under current law, but only for a limited time:

• Devices certified by a Notified Body under the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD): until the sooner of certificate expiry or 30 June 2028.
• Devices under the In Vitro Diagnostic Medical Devices Directive (IVDD): until the sooner of certificate expiry or 30 June 2030.
• Devices under the EU Medical Device Regulation (MDR), including custom made devices, and under the EU In Vitro Diagnostic Regulation (IVDR): until 30 June 2030.

The MHRA adds an important exception. The directive dates do not apply to Class I devices and general IVDs where neither the directive nor the EU MDR or IVDR requires a Notified Body. For those devices the question is whether they meet the EU MDR or IVDR, so check which group your device falls into before you rely on 2028.

A consultation on indefinitely recognising EU MDR and IVDR compliant devices, and on extending the MDD arrangements, closed on 10 April 2026. No outcome has been published. A draft Medical Devices (Amendment) Regulations 2026 was also published on the World Trade Organization notification portal on 8 May 2026, and as of 25 September 2026 we have not found it laid. Until something new is laid and in force, the UK Medical Devices Regulations 2002 as they stand today, regulation 7A included, are the law that applies. Our note on where UKCA marking stands in 2026 covers the marking side.

Northern Ireland is a different system. The EU MDR and IVDR apply there, devices are registered in EUDAMED, the European database on medical devices, and the representative you need is different too.

	Great Britain	Northern Ireland
Rules that apply	UK Medical Devices Regulations 2002, as amended	EU MDR since 26 May 2021, EU IVDR since 26 May 2022
Marking	UKCA, or CE accepted until the dates above	CE marking required; a combined CE and UK(NI) mark where a UK notified body does the conformity assessment
Representative	Sole UK Responsible Person, for manufacturers based outside the UK	Sole authorised representative based in the EU or Northern Ireland, for manufacturers based outside the EU and Northern Ireland, including Great Britain
Device registration	MHRA, in DORS	EUDAMED since 28 May 2026; custom made devices stay with the MHRA, within 28 days of being made available
Competent authority	MHRA	MHRA

The trap is assuming a Great Britain setup covers Northern Ireland. It does not. A device going to Belfast needs an EU or Northern Ireland based authorised representative and a EUDAMED registration.

What should you check before appointing a UK Responsible Person?

Most of what goes wrong with a UKRP was visible before the letter was signed. Work through this list with any firm you are considering, us included.

1. Where are they established, and what address goes on your labels and in DORS? Get it in writing, and check it matches everything else you are told.
2. Will the letter of designation name them as your exclusive UKRP, for the right legal manufacturer? The entity on the letter, the label and the registration should be identical.
3. Will they read your technical documentation before they sign? The first statutory task is theirs. If they will not look, they cannot meet it.
4. Have they built and defended technical files, or only reviewed them? The difference shows when the MHRA asks a hard question.
5. Where will your documentation live, and how fast can they produce it? Three working days for a post market surveillance report is the standard the Great Britain rules set.
6. What happens if there is a field safety action at 5pm on a Friday? Ask directly. The answer tells you whether the appointment is a mailbox or a working relationship.
7. Which other manufacturers do they represent? PARD cannot be searched by representative, so ask for references.
8. Do they cover Northern Ireland and the EU, or is that a second supplier? Two unconnected suppliers means two versions of the truth about the same file.
9. What does the exit look like? Termination, document handover and the label change should be written down before you need them.

What happens if you get the UK Responsible Person wrong?

We are not going to quote you penalties. The consequences that matter most are already written into the rules.

• No valid appointment, no lawful placing. Regulation 7A ties placing a device on the Great Britain market to a sole UKRP for any manufacturer based outside the UK.
• No confirmation, no registration. Until DORS confirms the device, you are not registered, whatever your distributor has already shipped.
• Your UKRP can be obliged to leave. If you breach your obligations, the UKRP has to end the relationship and inform the Secretary of State. Without a UKRP you cannot place devices on the Great Britain market.
• Labels that name the wrong UKRP do not meet the labelling requirement where the UKCA mark is affixed.
• Expired certificates stop sales. Devices showing Conformity Assessment Certificate Expired cannot be registered or placed on the market as new stock.
• Approval claims backfire. The MHRA says its logos, and claims that registration means approval, must not be used in marketing or on packaging.

Done before you launch, this is a planned piece of work. Done after a problem surfaces, it is a scramble that costs you market access while it gets fixed.

Where Worldwide Device Solutions fits

We act as UK Responsible Person from Newcastle upon Tyne and EU Authorised Representative from Cork, on one contract. One team holds your file for Great Britain, the EU and Northern Ireland, rather than two suppliers who have never spoken to each other about it. Our UK Responsible Person service starts with reading your technical documentation, because regulation 7A expects it, and the team behind it has taken 600+ companies to first time approval.

If you want to know whether your current appointment would stand up to an MHRA question, book a free consultation with Paul. If the file itself is the worry, our fixed fee Gap Assessment shows you where it stands. If your setup is already sound, that is what we will tell you.