UK Responsible Person for Medical Devices
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Define the UK Responsible Person mandate and coordinate MHRA registration and lifecycle communication for a foreign manufacturer.
Who needs a UK Responsible Person?
A manufacturer based outside the UK that places devices on the Great Britain market appoints a single UK Responsible Person (UKRP) for its devices under the applicable UK framework. The UKRP acts on the manufacturer’s behalf for specified tasks, including registration with the MHRA. Appointment does not itself establish device conformity or authorize a product that lacks a valid route.
Use the MHRA regulatory guidance and registration instructions to define the territory and scope. Great Britain comprises England, Wales and Scotland. Northern Ireland has different arrangements and should not be treated as the same registration/representation case.
What the UKRP arrangement should cover
| Area | Practical control | Evidence |
|---|---|---|
| Designation | Identify the manufacturer and devices under the written appointment | Accepted designation and scope |
| Conformity documentation | Verify required declaration and technical documentation are available | Current records, certificates and access procedures |
| MHRA registration | Register applicable devices and maintain accurate information | DORS account, submitted scope and updates |
| Authority cooperation | Supply requested information and support corrective action | Named contacts and escalation records |
| Safety communications | Inform the manufacturer of relevant complaints/incidents and cooperate as required | Complaint-forwarding, vigilance and field-action interfaces |
The manufacturer retains its own responsibilities. Ensure the UKRP can access the evidence and staff needed to perform its tasks, rather than providing only an address. Document absence coverage, urgent escalation and how records will remain available after a commercial relationship ends.
UKRP versus importer, EU AR and CH-REP
A UK importer performs a supply-chain role that is not automatically the UKRP appointment. One organization may provide several services, but the legal tasks, access and contractual scope must be clear. Similarly, an EU Authorized Representative does not automatically become a UKRP, and a Swiss CH-REP appointment covers a different territory.
Confirm labeling obligations for the actual conformity route. Do not apply a UKCA-specific identification rule indiscriminately to every eligible CE-marked device, or assume that a service contract replaces required product information.
Registration, fees and changing the UKRP
Registration should follow the current MHRA process and device categorization. From April 1, 2026, the published fee model is annual and category-based rather than one universal one-off portfolio fee. Government fees and professional service charges are separate; confirm the current account categories and official fee instructions before payment.
When changing UKRP, plan designation dates, account/device records, authority communications, labeling where applicable and documentation transfer. Preserve the manufacturer’s access and avoid a gap in representation or registration. A transfer is not completed merely by signing a new commercial agreement.
Connect the appointment to the GB conformity and CE-recognition route, current PMS requirements, complaints, incident reporting and field actions. Pure Global can support designation, registration and ongoing coordination within a defined service scope, with device conformity and remaining evidence work assessed separately.
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Plan your device registration, local representation and ongoing compliance with Pure Global.
Frequently asked questions
No. UKRP is a separate role under the Great Britain framework. Confirm the eligible UK establishment, written designation, MHRA registration and operational responsibilities even if the same service group offers EU representation.
No. Importing and the UKRP appointment are distinct roles. An organization may perform both where eligible, but the designation and responsibilities must be expressly defined and supported by access to the required information.
No. The device still needs a valid conformity route, applicable registration and labeling, and working postmarket controls. The appointment supports specified duties but does not replace the manufacturer’s compliance evidence.
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