Uk Mhra Medical Device Registration Responsible Person Service
A UK Responsible Person (UKRP) is the formally appointed UK-established representative of a medical-device manufacturer based outside the UK for Great Britain (England, Scotland and Wales). This is a defined regulatory role—not a postal address, importer of record, CE certificate or MHRA approval. The decision below is about representation; a device must separately meet its applicable conformity and MHRA registration requirements.
When do you need a UK Responsible Person?
Representation and device registration are assessed for devices placed on the Great Britain market. MHRA distinguishes the limited case of devices only put into service (without being placed on the market), for which it encourages but does not require registration; establish the factual supply pathway before concluding the UKRP/registration route.
Start with the manufacturer’s establishment and the destination market, not the distributor’s location or the device class. Northern Ireland follows a distinct EU-aligned regime.
| Situation | Representation conclusion | Next check |
|---|---|---|
| Manufacturer outside the UK; device placed on the Great Britain market | Appoint one UKRP for that manufacturer’s medical devices; UKRP registers on the manufacturer’s behalf. | Identify the legal manufacturer and all device ranges covered by one mandate. |
| Manufacturer established in the UK; Great Britain only | The manufacturer registers directly; an external UKRP is not required solely because it uses importers or distributors. | Verify the entity genuinely is the legal manufacturer, not merely its sales office. |
| UK importer or distributor of a foreign manufacturer’s device | Importing/distributing does not itself make the business the UKRP. It may act as UKRP if eligible and formally appointed. | Decide whether the importer is also taking the separate UKRP role; notify/importer details as required. |
| Northern Ireland or both GB and NI in scope | Since 28 May 2026, non-custom-made devices for NI generally require EUDAMED device registration, not a GB DORS UKRP filing; custom-made devices still follow the separate MHRA registration route. Check the EU/NI authorised-representative requirement. | Separate the EU/NI authorised-representative mandate and EUDAMED actor/device steps from any MHRA custom-made-device registration. For non-custom-made NI devices, EUDAMED device registration is the manufacturer’s responsibility, not that of the GB UKRP. A GB-established manufacturer supplying NI needs a separate EU/NI authorised representative; an EU- or NI-established manufacturer does not need one solely because it supplies NI. |
Who does what: the representation responsibility matrix
The representative takes specified duties under the UK Medical Devices Regulations 2002; it does not inherit every manufacturer obligation. Use this allocation in the services agreement and escalation protocol.
| Actor / workstream | Core responsibility | Boundary or evidence |
|---|---|---|
| Manufacturer — conformity | Establish the intended purpose, classification, technical documentation, conformity assessment, declarations and valid evidence. | UKRP checks that relevant documents and assessment exist; its appointment cannot cure a non-compliant device. |
| UKRP — MHRA and records | Provide proof of authority, register the manufacturer/devices, maintain available copies of technical file, declaration and applicable certificates, with amendments. | On MHRA request, supply necessary conformity information and documents. |
| UKRP — safety communications | Relay complaints and suspected incident reports immediately to the manufacturer; cooperate with MHRA on risk-reduction measures. | If samples/access exist, provide them on request; otherwise transmit the request and the manufacturer’s response. |
| Importer / distributor | Carry out their own supply-chain duties; an importer who is not UKRP alerts the manufacturer/UKRP of plans to import. | The manufacturer/UKRP supplies importer information to MHRA where required. |
| UKRP — regulatory breach | Where the manufacturer acts contrary to its obligations, terminate the legal relationship and inform MHRA and any relevant approved body. | Agree escalation channels and evidence preservation; contract terms cannot remove statutory duties. |
Appoint by a genuine, exclusive designation contract
MHRA calls the letter of designation a legal contract. It must identify the sole UKRP for the manufacturer and specify mandatory delegated tasks. The MHRA device-registration reference guide limits entered designation validity to five years; its dates should match the contract.
- Identify both legal entities, establishment addresses, authorised signatories, effective dates and all represented medical-device lines.
- State expressly that the appointee is the sole UK Responsible Person, covering mandatory statutory tasks rather than merely correspondence or a portal login.
- Attach an accurate manufacturer/device inventory and define supply of declarations, technical documents, certificates and updates to the UKRP.
- Define MHRA-response access, complaint and incident escalation, sample requests, corrective-action cooperation and named contacts.
- Specify change notification, renewal and termination handover, document continuity, allocation of commercial costs and liability/insurance terms without purporting to waive statutory obligations.
Appointment-to-DORS handoff: five checkpoints
This is the representative handoff, not a substitute for detailed device filing instructions.
- Confirm GB versus NI destinations and the legal manufacturer; check whether a UKRP is legally required.
- Verify the prospective UKRP’s UK establishment, ability to perform statutory work and absence of a conflicting appointment.
- Execute the exclusive contract and supply copies of technical/conformity records plus accurate device and importer details.
- UKRP submits its authority and manufacturer/device information through MHRA Device Online Registration System (DORS); resolve MHRA queries and applicable payments.
- Do not treat account creation or an application draft as registration: await MHRA confirmation of registered devices and keep the appointment live.
Four events that require immediate UKRP coordination
Record a named owner and evidence trail for each trigger. MHRA says registration information must remain current; a UKRP replacement requires a new registration.
| Trigger | UKRP/manufacturer action | Risk if missed |
|---|---|---|
| Changing UKRP | Plan termination and fresh exclusive designation; arrange new device registration and continuity of records. | Previous account/registration is not automatically transferred. |
| Designation near expiry | Renew and upload a valid letter before expiry; maximum entered validity is five years. | MHRA guide warns that expiry without a new letter suspends the account. If registration is suspended, do not treat new placing on the Great Britain market as permitted. |
| Device, manufacturer or importer changes | Check whether DORS needs updates or re-registration; inform MHRA of changed registration data. | Incorrect listing, possible fresh fee or unlawful marketing. |
| MHRA information request, complaint or incident | Use documented escalation: provide files, samples/access if available, and immediate manufacturer notice of suspected incidents. | Delayed regulator response or missed risk-control action. |
What the service does not buy: liability, labelling and fees
Statutory enforcement exposure is broader than contract liability: under regulation 60(3) of the UK Medical Devices Regulations 2002, a UKRP may be proceeded against as a person placing the device on the market or supplying it after placement. This does not automatically make it the legal manufacturer; assess the precise facts and applicable provisions.
The UKRP has its own statutory obligations and may have contractual exposure. Appointment does not convert the UKRP into the manufacturer, grant CE/UKCA certification, erase the manufacturer’s obligations or guarantee that MHRA will accept a device. Liability allocation, indemnities and insurance need review against the actual contract and applicable law; there is no general automatic liability cap asserted here.
For UKCA-marked devices, where applicable, the UKRP name/address must appear on the device label, outer packaging or instructions for use. For CE-only devices those details are not required solely by the UKRP rule; if both CE and UKCA appear, the UKCA labelling rule applies. Do not extrapolate the Great Britain label position to Northern Ireland.
Distinguish private UKRP service charges from MHRA statutory registration charges. Since 1 April 2026 MHRA uses an annual GMDN-category fee structure, with new-registration fees and certain changes; uploading a replacement designation letter is listed as free of charge, whereas changing UKRP requires a new registration. Check current MHRA charges before budgeting. MHRA device registration is not approval or certification.
The boundary with advisory and filing work
For difficult classification, evidence and market-route decisions, use MHRA medical-device registration consulting; for the full DORS application workflow, use MHRA device registration filing service. This page instead decides who can be appointed and how that appointment is run. For a wider cross-sector distinction, see UK responsible-person services across product regimes.
UKRP appointment: specific questions
We already have an EU authorised representative and a valid CE mark. Can it replace the UKRP for Great Britain?
No. A non-UK manufacturer placing medical devices on the GB market needs its own sole UKRP. CE recognition and EU representation address different requirements.
Can our UK distributor be named as the UKRP automatically?
No automatic appointment. A distributor or importer may serve if established in the UK and expressly designated for the mandatory tasks; their importer/distributor duties remain separate.
Can we hire one UKRP for Class I devices and another for Class III devices?
MHRA guidance calls for a single UKRP for the non-UK manufacturer’s medical devices. Segmenting representation by class is not a substitute for the sole appointment.
Does a UKRP appointment cover Northern Ireland too?
Not by itself. NI applies EU MDR/IVDR rules and authorised-representative logic, with specific EUDAMED/DORS cases. Check the NI route separately, especially for custom-made devices.
What happens if we replace our UKRP or let its designation expire?
A change of UKRP calls for new registration. MHRA’s guide says an expired designation not renewed in time can suspend the account; organise the new mandate and records before the change.