UK Responsible Person (UKRP) for Medical Devices and IVDs
A UK Responsible Person is the UK-based legal entity that a manufacturer outside the United Kingdom must appoint before placing a medical device or in vitro diagnostic device on the Great Britain market. The UKRP registers the devices with the MHRA, holds the technical documentation and acts as the regulator’s point of contact. I3CGLOBAL’s UK company has acted as UK Responsible Person for manufacturers in more than 30 countries since the role was created on 1 January 2021. This guide explains who needs a UKRP, what the law requires of one, which documents you need, how appointment and MHRA registration work and what it costs in 2026.
Definition
What Is a UK Responsible Person?
A UK Responsible Person (UKRP) is a person or company established in the United Kingdom that acts on behalf of a manufacturer based outside the UK in relation to specified tasks under the Medical Devices Regulations 2002 (UK MDR 2002). The role was introduced by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and 2020, which amended UK MDR 2002 to replace the EU Authorised Representative for the Great Britain market after the end of the Brexit transition period. The requirement took effect on 1 January 2021 and applies in England, Scotland and Wales.
The UKRP is the UK counterpart of the EU Authorised Representative. It is the manufacturer’s legal representative with the Medicines and Healthcare products Regulatory Agency (MHRA), registers each device in the MHRA’s Device Online Registration System (DORS), keeps a copy of the technical documentation available for inspection and cooperates with the MHRA on vigilance and corrective action. The appointment must be set out in a written mandate, usually called a Letter of Designation or UKRP agreement, that records the full legal name and address of both parties and the tasks the UK Responsible Person has accepted.
Podcast: UK Responsible Person explained. Listen to our regulatory team discuss the UKRP role, MHRA registration and the common mistakes foreign manufacturers make when entering Great Britain.
Scope
Who Needs a UK Responsible Person?
Every manufacturer that is not established in the United Kingdom and wants to place a medical device, active implantable device or IVD on the Great Britain market must appoint a UK Responsible Person. The obligation does not depend on the device class, on whether the device carries UKCA or CE marking, or on whether the product is hardware or software. A Class I wound dressing from India, a Class III implant from Germany and a cloud-based diagnostic software from the United States all need a UKRP before the first unit is sold in Great Britain.
| Manufacturer location | Target market | Representative required | Where to register |
|---|---|---|---|
| Outside the UK (EU, USA, India, China, anywhere else) | Great Britain | UK Responsible Person | MHRA DORS, submitted by the UKRP |
| Outside the UK | Northern Ireland | EU Authorised Representative (non-EU manufacturers); UKRP not required | EUDAMED from 28 May 2026 (custom-made devices still with the MHRA) |
| Great Britain | Great Britain | None; the manufacturer registers directly | MHRA DORS |
| Great Britain | Northern Ireland or the EU | EU Authorised Representative based in the EU or Northern Ireland | EUDAMED |
| Northern Ireland | Great Britain | None; the manufacturer is established in the UK | No further registration in Great Britain once the device is registered for the Northern Ireland market |
The same rule covers rebranders and own-brand labellers who place devices on the market under their own name, assemblers of system and procedure packs, and manufacturers of custom-made devices. Importers and distributors in Great Britain have their own obligations under UK MDR 2002, but they cannot stand in for the manufacturer’s UK Responsible Person unless the manufacturer formally appoints them in writing and they accept the statutory duties described below.
Software as a medical device (SaMD) is treated no differently. If the software meets the UK MDR 2002 definition of a medical device, whether it is standalone, cloud hosted or embedded in hardware, the developer must appoint a UKRP and register the software in DORS. Our classification guide explains how to decide the class, which can range from Class I to Class IIb or III depending on the clinical function and risk.
Obligations
What Are the Legal Duties of a UK Responsible Person?
UK MDR 2002, as amended, sets out the tasks a UK Responsible Person must carry out. The MHRA’s guidance on regulating medical devices in the UK repeats them and the UKRP agreement must cover them all. A provider that offers only an address and a DORS login is not fulfilling the role.
Verify conformity evidence
Ensure that the declaration of conformity and technical documentation have been drawn up and, where required, that the manufacturer has completed the appropriate conformity assessment procedure with a UK Approved Body or EU Notified Body.
Hold the technical documentation
Keep a copy of the technical documentation, the declaration of conformity and the relevant certificates available for the MHRA for the retention period required by the regulations.
Register with the MHRA
Register the manufacturer and each device in DORS before the devices are placed on the Great Britain market, keep the records accurate and pay the statutory fee.
Respond to MHRA requests
Provide the MHRA with all information and documentation needed to demonstrate conformity, in English, and arrange access to samples or devices when requested.
Cooperate on vigilance and CAPA
Cooperate with the MHRA on any preventive or corrective action taken to eliminate or mitigate risks, and forward complaints and incident reports from UK users to the manufacturer without delay.
Monitor and, if necessary, terminate
Inform the manufacturer when it is acting contrary to its obligations and, if the manufacturer does not comply, terminate the mandate and notify the MHRA and, where relevant, the Approved Body.
In practice I3CGLOBAL’s UKRP service adds the work around these duties: GMDN code identification at no extra charge, review of labels and instructions for use before registration, reminders for the annual MHRA fee, and support with post-market surveillance under the Great Britain PMS Regulations (SI 2024/1368) that have applied since 16 June 2025, including serious incident and field safety corrective action reporting through the MHRA MORE portal.
Comparison
UKRP vs EU Authorised Representative: What Is the Difference?
The UK Responsible Person and the EU Authorised Representative perform the same function in different territories. One cannot replace the other: a manufacturer selling in both Great Britain and the EU needs both appointments, and a manufacturer selling in Northern Ireland needs the EU Authorised Representative rather than the UKRP.
| Topic | UK Responsible Person (UKRP) | EU Authorised Representative (EC REP) |
|---|---|---|
| Territory | Great Britain (England, Scotland, Wales) | EU, EEA and Northern Ireland |
| Legal basis | UK MDR 2002 as amended by the EU Exit Regulations 2019 and 2020 | EU MDR 2017/745 Article 11 and IVDR 2017/746 Article 11 |
| Regulator | MHRA | National competent authorities of the member states |
| Must be established in | The United Kingdom | An EU or EEA member state, or Northern Ireland |
| Required for | Manufacturers outside the UK | Manufacturers outside the EU, including UK manufacturers |
| Registration system | MHRA DORS | EUDAMED |
| Registration fee | GBP 300 per year per GMDN Level 2 category (for 2026/27; reviewed each year) | No EUDAMED fee; national fees vary |
| Labelling | UKRP name and UK address where the UKCA mark is affixed | EC REP symbol with name and EU address on CE-marked devices of non-EU manufacturers |
| Liability | Statutory duties; liability as agreed in the mandate | Legally liable for defective devices jointly and severally with the manufacturer |
| Typical appointment time | 3 to 4 working days with I3CGLOBAL | 5 to 7 working days with I3CGLOBAL |
I3CGLOBAL provides both services from group companies in the UK and the EU, so a manufacturer can hold one set of technical documentation, one point of contact and aligned contracts for both markets. Details of the European service are on our EU Authorised Representative page.
Process
How Do You Appoint a UK Responsible Person?
Appointment is a contractual step followed by a regulatory one. With the documents ready, I3CGLOBAL completes the appointment in three to four working days and, in our experience, the MHRA confirms the registration four to six working days after submission.
- Request a proposalTell us the device names, classes, GMDN categories and the manufacturing site. We confirm the UKRP annual fee and the MHRA statutory fee that will apply.
- Sign the UKRP agreementThe agreement, which serves as the Letter of Designation, names both parties, lists the devices and sets out the statutory duties, the term and the termination terms.
- Submit the documentsDeclaration of conformity, certificates, labels, instructions for use, company registration certificate and GMDN codes. We review them for consistency with the labelling before anything is filed.
- DORS account and registrationWe create or use our UKRP account in DORS, add the manufacturer, enter the devices and GMDN codes, upload the mandate and pay the MHRA fee. See the MHRA registration guide for the detailed steps.
- MHRA confirmationThe MHRA reviews the submission and confirms the registration. The manufacturer and devices then appear in the MHRA Public Access Registration Database (PARD).
- Update labels and start sellingWhere the UKCA mark is affixed, add the UKRP name and address to the label, packaging or instructions for use. Devices can be placed on the Great Britain market once registration is confirmed.
Verify any UKRP before you sign. There is no MHRA accreditation scheme for UK Responsible Persons, so check that the provider is a UK-registered company listed as an active UKRP in DORS. You can verify I3CGLOBAL’s UKRP and MHRA registration status on our UK verification page.
Documentation
Which Documents Does a UK Responsible Person Need?
The UKRP cannot register a device it has not verified. The documents below are needed for the appointment and the first DORS submission; the technical documentation itself can be held by the manufacturer provided the UKRP has a guaranteed right of access.
| Document | Why the UKRP needs it | Status |
|---|---|---|
| Signed and dated UK declaration of conformity | Confirms the legal manufacturer, device names and models, intended use, classification under UK MDR 2002, conformity assessment route and GMDN codes | Required |
| UKRP agreement or Letter of Designation | The statutory mandate that must be uploaded to DORS | Required |
| Manufacturer’s certificate of incorporation | Confirms the legal entity and address that will appear in PARD and on labels | Required |
| UK Approved Body or EU Notified Body certificates | Needed for Class I sterile or measuring, Class IIa, IIb, III and higher-risk IVDs | Conditional |
| Labels and instructions for use | Checked for English language, UKCA or CE mark, body number and UKRP details | Required |
| GMDN code and term for each device | Determines the registration structure and the number of Level 2 categories charged | Required |
| Technical file index and access arrangement | Shows the UKRP can produce the documentation for the MHRA on request | Required |
| Authorised signatory details and contact person | Used by the MHRA for communications about the registration | Required |
| Free sale certificate or apostille | Requested by some export markets after GB registration; I3CGLOBAL arranges it in 6 to 8 working days | Optional |
Manufacturers that need help with the technical file or the UKCA marking route itself can combine the UKRP service with our consulting, which is how most of our UKRP clients started.
Labelling
Must the UK Responsible Person Appear on the Label?
Where the UKCA mark is affixed, the name and address of the UK Responsible Person must appear on the label, the outer packaging or the instructions for use. This applies to UKCA-only devices and to dual-marked devices that carry both UKCA and CE marks. The UKRP details can be added by means of a sticker or an insert, which allows manufacturers to use one global label with a GB-specific addition.
UKRP name and UK address required on the label, packaging or IFU, together with the UKCA mark and, where applicable, the UK Approved Body number. Labels and IFU must be in English.
No legal requirement to show the UKRP on the label while the device relies on CE recognition. The device still needs a UKRP and DORS registration; the EU Authorised Representative shown on the label does not satisfy the GB obligation.
I3CGLOBAL reviews every label before registration. Common findings are a missing UKRP address on UKCA-marked products, a trade name on the label that does not match the DORS entry, and outdated Notified Body numbers after a certificate transfer.
CE Recognition
How Long Is CE Marking Accepted in Great Britain?
CE-marked devices can be placed on the Great Britain market for a limited period. A UK Responsible Person and MHRA registration are still required during this time. The dates below come from the MHRA guidance on regulating medical devices in the UK.
| Device and certificate | Accepted in Great Britain until |
|---|---|
| Medical devices under the EU MDD or AIMDD | Certificate expiry or 30 June 2028, whichever is sooner |
| IVDs under the EU IVDD | Certificate expiry or 30 June 2030, whichever is sooner |
| Devices under the EU MDR and IVDs under the EU IVDR | 30 June 2030 |
The UK government has announced that it will consult on indefinite recognition of CE-marked medical devices. Check the MHRA guidance for the current position before you plan a UKCA transition.
Costs
How Much Does a UK Responsible Person Cost?
Two fees apply. The UKRP service fee is paid annually to the UK Responsible Person; the MHRA registration fee is a statutory fee paid to the regulator through DORS. From 1 April 2026 the MHRA fee changed from a one-off GBP 261 per application to an annual fee of GBP 300 for each GMDN Level 2 category held on 31 March, payable through the Device Online Registration System. Mid-year registrations are charged pro rata.
The fee is charged for each GMDN Level 2 category, or Level 1 category where no Level 2 exists. It is due within 90 days of 1 April each year and is paid only through DORS. The MHRA reviews the amount every year and does not offer waivers, SME rates or instalments. The details are in the MHRA device registration fee guidance.
| Fee | Paid to | Basis | 2026 position |
|---|---|---|---|
| UKRP annual service fee | I3CGLOBAL UK | Per manufacturer, scaled by number of devices and classes | Fixed annual quote; see the UKRP fee page |
| MHRA registration fee | MHRA via DORS | Per GMDN Level 2 category, per year | GBP 300 per category for 1 April 2026 to 31 March 2027. Outstanding 2026/27 fees had to be paid by 6 November 2026, and the MHRA suspends accounts with unpaid fees |
| Changes to a registration | MHRA via DORS | Adding devices within an existing category | No additional annual fee until a new category is added |
| Change of UKRP | MHRA via DORS | Treated as a new registration under the new UKRP account | A statutory fee may be payable; the amount is shown in DORS |
Our UKRP fee and MHRA fee page gives the current service fee bands and a calculator that covers UKRP, MHRA, EU Authorised Representative and free sale certificate costs.
Switching provider
How Do You Change Your UK Responsible Person?
A manufacturer can change its UK Responsible Person at any time. The MHRA requires a new registration: the new UKRP registers the manufacturer and devices from its own DORS account, and the outgoing UKRP must deregister the devices. The MHRA registration guidance states that a statutory fee may be payable for the change, so confirm the amount shown in DORS before you switch. Most manufacturers time a switch to coincide with the end of the current contract or the 31 March fee reference date.
- Sign with the new UKRPKeep the old mandate in force until the new registration is confirmed so the devices are never on the market without a registered UKRP.
- New DORS registrationThe new UKRP submits the manufacturer, devices, GMDN codes and mandate; the MHRA confirms in about 4 to 6 working days.
- Deregistration by the former UKRPThe outgoing representative removes the devices from its account. The MHRA has closed the DORS accounts of Great Britain-based Authorised Representatives that had not changed their role to UKRP by 30 March 2026, so devices still held under those legacy accounts must be re-registered by a UKRP.
- Update labels and IFUReplace the UKRP name and address on UKCA-marked products and inform distributors in Great Britain.
Northern Ireland
Is a UKRP Needed for Northern Ireland?
No. Northern Ireland follows the EU MDR and IVDR under the Windsor Framework, so a manufacturer outside the EU and UK that sells in Northern Ireland needs an EU Authorised Representative, not a UKRP, and registers in EUDAMED from 28 May 2026 rather than in DORS. Custom-made devices remain registrable with the MHRA within 28 days. See the MHRA guidance on the regulation of medical devices in Northern Ireland. A UKRP is needed only for the Great Britain part of the UK market, and a manufacturer in Northern Ireland can place CE-marked devices in Great Britain without one. Our UKCA marking guide explains the UKNI indication and the Northern Ireland rules in more detail.
Work with I3CGLOBAL
Why Appoint I3CGLOBAL as Your UK Responsible Person?
I3CGLOBAL’s UK company is a registered UK business listed in DORS as an active UK Responsible Person, backed by a regulatory team that has worked on CE and UKCA projects since 1999. We are not a mailbox service: every appointment is handled by consultants who review your documents before they reach the MHRA.
- UKRP appointment in 3 to 4 working days and MHRA registration confirmed in a further 4 to 6 working days
- GMDN code identification included at no extra charge, which also keeps your annual MHRA fee as low as the rules allow
- Label and IFU review, technical file custody and MHRA correspondence in English
- Post-market surveillance and MORE portal reporting support under the 2024 PMS Regulations
- Group companies that also act as EU Authorised Representative and US Agent, with multi-currency invoicing
- UK Free Sale Certificates ordered from the MHRA for export, once your devices are registered in DORS
Request your UKRP proposal
Send us your device list and classes and we will confirm the UKRP fee, the MHRA fee and the documents we need within one working day.
FAQs
UK Responsible Person: Frequently Asked Questions
What is a UK Responsible Person?
A UK Responsible Person (UKRP) is a company or individual established in the United Kingdom that a manufacturer based outside the UK must appoint to act on its behalf under the UK Medical Devices Regulations 2002. The UKRP registers the devices with the MHRA through DORS, holds the technical documentation and declaration of conformity for inspection, responds to MHRA requests and cooperates on vigilance and corrective action.
Who needs a UK Responsible Person?
Any manufacturer of medical devices, active implantable devices or IVDs that is not established in the United Kingdom and wants to place devices on the Great Britain market. The requirement applies to every device class, to UKCA-marked and CE-marked devices, and to software as a medical device. UK-based manufacturers register directly and do not need a UKRP.
Is a UKRP required for CE-marked devices sold in Great Britain?
Yes. CE marking is accepted in Great Britain, but recognition of the mark does not remove the registration and representation requirements. A non-UK manufacturer must still appoint a UK Responsible Person and the UKRP must register each device in DORS before it is placed on the market.
How long does it take to appoint a UK Responsible Person?
With I3CGLOBAL, appointment takes three to four working days once the agreement is signed and the documents are received. The MHRA then typically confirms the DORS registration within four to six working days, so most manufacturers are registered within two weeks.
How much does a UK Responsible Person cost?
Two fees apply: the UKRP annual service fee paid to the representative and the MHRA registration fee paid through DORS. Since 1 April 2026 the MHRA fee is GBP 300 per year for each GMDN Level 2 category, replacing the previous one-off GBP 261 application fee. I3CGLOBAL publishes its UKRP service fee bands and a fee calculator on the UKRP fee page.
Must the UK Responsible Person's name appear on the label?
Where the UKCA mark is affixed, including dual UKCA and CE marked devices, the UKRP name and UK address must appear on the label, packaging or instructions for use. A sticker or insert is acceptable. For devices sold in Great Britain under CE recognition alone there is no labelling requirement, although registration and a UKRP are still required.
What is the difference between a UK Responsible Person and an EU Authorised Representative?
The UKRP represents a non-UK manufacturer to the MHRA for the Great Britain market under UK MDR 2002 and registers devices in DORS; the EU Authorised Representative represents a non-EU manufacturer to EU competent authorities under EU MDR and IVDR for the EU, EEA and Northern Ireland and registers in EUDAMED. The roles are independent and a manufacturer selling in both markets needs both.
Do I need a UKRP for Northern Ireland?
No. Northern Ireland follows EU medical device law, so non-EU manufacturers need an EU Authorised Representative and register in EUDAMED from 28 May 2026. The UK Responsible Person covers only Great Britain: England, Scotland and Wales.
Can my UK distributor act as my UK Responsible Person?
Only if the distributor is established in the UK, is formally appointed in writing and accepts all the statutory UKRP duties, including holding the technical documentation and cooperating with the MHRA. Many manufacturers prefer an independent UKRP so that commercial disputes with a distributor cannot interrupt market access.
Does one UKRP cover all my devices?
Yes. One UK Responsible Person can represent all the devices of a manufacturer, provided each device is registered in DORS. A manufacturer may also appoint different UKRPs for different devices, but each UKRP then holds a separate registration.
How do I change my UK Responsible Person?
Sign with the new UKRP, who registers the manufacturer and devices from its own DORS account; the MHRA requires a new registration and a statutory fee may be payable. The outgoing UKRP then deregisters the devices and labels on UKCA-marked products are updated. Keep the old mandate in place until the new registration is confirmed.
Is I3CGLOBAL an MHRA-approved UK Responsible Person?
The MHRA does not accredit or approve UK Responsible Persons, so no provider can claim MHRA approval. I3CGLOBAL's UK company is a registered UK business listed in DORS as an active UKRP for manufacturers in more than 30 countries, and its status can be verified on our UK verification page.
How long is CE marking accepted in Great Britain?
CE-marked devices under the EU MDD or AIMDD are accepted until certificate expiry or 30 June 2028, whichever is sooner. IVDs under the IVDD, and devices under the EU MDR and IVDR, are accepted until 30 June 2030. A UK Responsible Person and MHRA registration are required throughout.
When is the MHRA annual fee due?
The fee is due within 90 days of 1 April each year and is paid through DORS. For 2026/27, outstanding fees had to be paid by 6 November 2026. The MHRA suspends accounts with unpaid fees.
Can an individual act as a UK Responsible Person?
Yes. The UK Responsible Person can be a person or a company, but must be established in the United Kingdom and must accept all the statutory duties in a written mandate.
What is a Letter of Designation?
It is the written mandate in which the manufacturer appoints the UK Responsible Person. It names both parties and lists the tasks the UKRP has accepted, and it is uploaded to DORS with the registration.