UK Responsible Person: Statutory Role, Duties and the 2026 CE Recognition Decision

1. Key takeaways

Manufacturers established outside the United Kingdom must appoint one and only one UK Responsible Person (UKRP) before placing devices on the market in Great Britain, and that UKRP assumes part of the manufacturer’s statutory obligations. The UKRP must be established in Great Britain; an address in Northern Ireland does not satisfy the requirement. The UKRP’s legal status is set out in reg 60, while the substance of its duties appears across the relevant Parts of the UK MDR 2002. The long-term recognition decision for CE marking issued on 21 October 2026 expressly retains UKRP obligations. In practical terms, the UKRP is not a mailing address or a paperwork formality: it is an accountable regulatory counterpart of the manufacturer inside the United Kingdom, and the appointment decision shapes labelling, registration, incident handling and every point of enforcement contact. Choosing a UKRP should therefore be treated as a compliance architecture decision rather than a procurement exercise. The sections below set out the legal anchor, the complete itemised duty list, the conditional labelling rule, and the selection criteria that follow from them, so that the appointment can be made deliberately and documented defensibly.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 60 (status of the UKRP); reg 21C (requirement to appoint a UKRP for active implantable medical devices); reg 44ZJ(2)(b) (the initial FSCA report must include the UKRP’s name and contact details).
• Official guidance: GOV.UK, Regulating medical devices in the UK, and GOV.UK, Register medical devices to place on the market.
• GOV.UK consultation response (published 21 October 2026): manufacturers of CE-marked devices must still appoint a UKRP.

Taken together, these sources form a coherent chain of duties. Reg 60 establishes who the UKRP is and requires establishment in the United Kingdom — and, for the Great Britain route, in Great Britain specifically, which is why a Northern Ireland address cannot be substituted. Reg 21C extends the appointment requirement to active implantable medical devices, and reg 44ZJ(2)(b) weaves the UKRP into the field safety corrective action reporting chain, so the UKRP’s name and contact details must be available to MHRA from the very first report. The consultation response published on 21 October 2026 closes the question that had lingered since the transition period ended: even where a device carries CE marking under the long-term recognition policy, the duty to appoint a UKRP stands unchanged. Any market-entry plan for Great Britain should therefore treat the UKRP appointment as a precondition of the first placing on the market, not as an administrative step to be completed afterwards.

3. Expert insights

Insight 1: the UKRP’s duties are set out as an itemised list. Official guidance summarises the UKRP’s duties as follows: (1) ensure that the declaration of conformity and the technical documentation have been drawn up and, where applicable, that the conformity assessment procedure has been completed; (2) keep a copy of the technical documentation, a copy of the declaration of conformity and, where applicable, copies of the relevant certificates, including any amendments and supplements, available for inspection by MHRA; (3) provide MHRA, on request, with all the information and documentation necessary to demonstrate the conformity of the device; (4) where samples of the device are available or the device can otherwise be made accessible, comply with MHRA’s request to provide samples or access; (5) where neither samples nor access are available, communicate MHRA’s request to the manufacturer and reply to MHRA stating whether or not the manufacturer complied; (6) cooperate with MHRA on any preventive or corrective action taken to eliminate, or mitigate, risks posed by the device; (7) immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents; and (8) where the manufacturer breaches its obligations, terminate the legal relationship and inform MHRA and, where applicable, the relevant conformity assessment body.

Insight 2: duties (7) and (8) are the UKRP’s high-responsibility zone. Duty (8) in particular — terminating the legal relationship with the manufacturer and reporting to MHRA — means the UKRP is not a nominal agent but a party carrying active supervisory and reporting obligations. A UKRP that merely collects an annual fee and forwards correspondence will fail these duties precisely when they matter most: when a suspected incident surfaces, or when the manufacturer’s conduct comes into question and the regulator looks to the person established on its territory. This is why selecting a UKRP should focus on the candidate’s systems and willingness to perform the duties, rather than on a price comparison alone. During due diligence, ask how complaints are received and timestamped, how quickly manufacturers are notified, and whether the candidate has ever actually terminated an appointment for cause.

Insight 3: the UKRP labelling duty is condition-triggered. The official guidance is explicit: the UKRP’s name and address must appear on the product label, the outer packaging or the instructions for use — but only where the UKCA mark has been affixed. Devices bearing only CE marking do not need to carry the UKRP’s details, unless both the CE and UKCA marks are affixed. This conditional design matters for stock and artwork planning: a labelling change is needed only when UKCA marking is introduced, but once that happens the UKRP details become a mandatory label element, and artwork should be updated before goods are released. Companies running dual-marking strategies should track which product families carry which marks so the labelling obligation is applied correctly to each.

4. Practical recommendations

GRZAN recommends assessing and selecting the UKRP through obligation-by-obligation mapping: require each candidate UKRP to explain, duty by duty across the eight items above, its performance mechanism, response time and record-keeping method, and write those commitments into the service agreement. This converts a marketing brochure into a verifiable specification, and it makes the later termination discussion easier because expectations were documented at the outset. On the manufacturer side, proactively establish a two-way notification channel for complaints and suspected incidents with the UKRP, so the UKRP can relay reports to the manufacturer within the statutory time limits and the manufacturer can feed investigation outcomes back for onward communication to MHRA. Review the channel annually, including out-of-hours contact routes, because incidents rarely arrive during office hours. Finally, keep evidence of the appointment itself — the signed letter of designation — together with records showing how each duty has actually been performed over time.

5. Verification checklist

Before signing off the UKRP appointment, confirm each of the following items.

• □ A sole UKRP has been appointed and it is established in Great Britain
• □ Written evidence of authorisation (the letter of designation) has been obtained
• □ Mechanisms for performing all eight UKRP duties are written into the agreement
• □ A two-way notification channel for complaints and suspected incidents is in place
• □ The labelling duty has been assessed according to whether the UKCA mark is affixed

Regulatory information verified as of 29 October 2026.

• Appointment of the UK responsible person (UKRP) and support for signing the letter of designation
• End-to-end MHRA registration (DORS) filing and account lifecycle management
• Device classification assessment, GMDN code selection and annual registration fee calculation
• Dual-pathway design for Great Britain and Northern Ireland, including the UK(NI) option
• Post-market surveillance (PMS) system setup, PMSR/PSUR preparation and vigilance report submission
• Emergency handling of serious adverse events and field safety corrective actions (FSCA)
• Monitoring of UK regulatory changes and compliance gap assessment

Working with GRZAN. GRZAN Global supports manufacturers entering the United Kingdom market with the full scope of UKRP and fee-budgeting services described above: appointing and documenting the UK responsible person (UKRP), managing MHRA DORS registration and account lifecycles, forecasting annual registration fees by GMDN category, and maintaining compliance through post-market surveillance and regulatory change monitoring. Whether you are appointing your first UKRP or reviewing an existing arrangement, our team can benchmark your current setup against the eight statutory duties and the 2026 fee structure. For a consultation, contact us at info@grzanglobal.com.