Changing a UK Responsible Person: Registration and Handover

For a medical device manufacturer outside the UK that has selected a replacement UK Responsible Person (UKRP), the next task is a new MHRA registration and a controlled document handover. MHRA lists a change of UKRP as requiring a new registration. Updating a contact name or uploading a replacement Letter of Designation in an existing appointment does not accomplish that change. MHRA registration guidance.

What changes in the MHRA registration

Great Britain means England, Scotland and Wales. MHRA requires devices to be registered before placement on that market, and manufacturers outside the UK must appoint one UKRP for all their devices. The representative performs the manufacturer’s registration tasks and has continuing responsibilities for documentation, complaints and cooperation with MHRA. The manufacturer should therefore scope the handover across its entire Great Britain portfolio, rather than only the products sold by a particular distributor.

The Great Britain registration and UKRP duties are set out in UK MDR 2002 regulation 7A for general medical devices, regulation 21A for active implantable devices, and regulation 33A for IVDs. Each includes a duty to notify changes to information previously supplied. Read the territorial version that applies to the device and market; similarly numbered Northern Ireland provisions are not interchangeable with these Great Britain requirements.

Registration is separate from conformity assessment. MHRA expressly states that registration does not constitute approval, certification or endorsement of a device. An accepted registration cannot cure an invalid certificate, an unsuitable classification or an incomplete technical file. Keep the registration task and the conformity review connected in the project plan, while recording their evidence separately.

For background on the marking routes, see the UK medical device regulation guide. The steps below address execution of the registration handover after the replacement representative has been chosen.

The DORS sequence and the checks before unregistration

MHRA’s Account Management Reference Guide, April 2026 documents the outgoing representative’s unregistration action on pages 38–39. The Unregister Manufacturer option is available only for registered manufacturers with no applications in progress, including TEMP drafts and submitted applications awaiting completion. This is a practical dependency to check before setting a cutover date; a pending amendment on the outgoing account can prevent the expected action.

The Device Registration Reference Guide, April 2026 explains how a UKRP adds a represented manufacturer on pages 86–89. Its warning against multiple accounts concerns manufacturers the representative has already registered: manage those existing records instead of making duplicates. It is not an instruction to reuse or reactivate the outgoing representative’s unregistered account. MHRA’s account guide says that an unregistered account cannot be reinstated and that the manufacturer and devices would need to be registered again.

Prepare the data outside DORS first, then use a portal draft where the live system permits it. The device guide, page 97, says TEMP applications are deleted 90 days after their last saved date and cannot be recovered. Assign a person to monitor draft age and outstanding queries. The guidance also warns that screenshots may lag current screens; follow the live messages rather than treating an old screenshot as a guaranteed click path.

Define who can lift the internal placement hold and what they must check. A useful release record identifies the manufacturer, incoming UKRP, accepted application, devices covered and any unresolved restrictions. Agree escalation contacts before the outgoing appointment ends. If the portal prevents the expected sequence, contact MHRA with the relevant organisation and application references instead of creating speculative extra accounts.

What is chargeable under the 2026 fee model

For the charging period from 1 April 2026 to 31 March 2027, MHRA publishes a unit fee of £300 per year per chargeable GMDN Level 2 category, using Level 1 where no Level 2 category exists. GMDN means Global Medical Device Nomenclature. It identifies device types; the charge is not a separate £300 bill for every catalogue number, model or individual GMDN term. MHRA’s April 2026 fees guidance explains category allocation and payment.

The fees guide, pages 5–7, explains that DORS minimises chargeable category overlaps. Several GMDN terms can share a category, and a term associated with more than one category is not automatically charged multiple times. Use the device-data export and DORS payment page to reconcile the portfolio; do not infer the category count from commercial labels such as surgical instruments or wound care.

For new chargeable registrations during the year, DORS divides the annual fee by 365 and applies the days remaining to 31 March, rounding the amount payable to the nearest penny. The guide also warns that removing the last device in a category and later registering another in that category can produce a fresh pro rata charge. That warning is not permission to overlap different UKRP appointments. If the transfer’s fee treatment is unclear, obtain MHRA clarification using both records and their payment references.

The registration webpage records a special extension of the first annual-payment deadline to 31 July 2026. That date is historical as of this October review and is not the deadline for a new October application. New registration fees are payable through DORS at application. The unit rate can change annually, so recheck it when planning a later charging period.

For BACS or CHAPS, use the unique reference shown on the DORS payment page and follow the proof-of-payment instructions. The official guidance warns that an unidentifiable payment can delay the application and potentially suspend the account. The fees manual says MHRA does not issue advance invoices; a pro forma invoice is available through the annual-fee link, and a paid invoice follows payment. Record the application reference, payment reference, remittance evidence and acceptance separately.

Keep MHRA statutory charges separate from the incoming UKRP’s service charges and any document review, translation or artwork costs. Free portal maintenance does not imply free professional work. The existing UKRP pricing guide addresses commercial pricing and exit planning; verify the current statutory charge against MHRA rather than a service-provider quote.

The Letter of Designation and expiry control

MHRA requires the Letter of Designation to be a legal contract that identifies the exclusive UKRP and specifies the mandatory tasks performed for the manufacturer. Those tasks include checking that conformity documentation has been prepared, keeping copies available for MHRA, responding to information requests, cooperating on corrective action, and promptly forwarding complaints and suspected-incident reports to the manufacturer. Use the regulator’s UKRP responsibilities to check the scope.

The April 2026 account manual, pages 19–22, and device manual, page 89, require the uploaded validity dates to match the representation contract’s start and end dates. The maximum validity accepted for this designation is five years. This is a registration-document control; it does not establish a universal five-year commercial service term or a five-year retention period for every record.

Plan clear end and start dates without simultaneous exclusive appointments. Before filing, check legal entity names, addresses, scope and the recorded dates against the executed appointment document. Assign responsibility for the replacement letter and for checking that MHRA has accepted the update. Uploading a file alone should not close the renewal task in the quality system.

MHRA describes reminders at three, two and one month before expiry. If no valid replacement letter is uploaded before the existing one expires, the account is suspended and its public registration details are removed. New placements cannot continue under a suspended registration. Keep independent expiry alerts and a backup owner, rather than relying solely on an email reaching the main portal contact. Any earlier internal renewal target is a planning choice, not a published statutory 60-day deadline.

The document handover checklist

The legal requirement is to keep copies of the relevant technical documentation, declaration of conformity and certificates available for MHRA, including amendments and supplements. A controlled electronic repository can support the handover, provided the incoming UKRP has the necessary copies and can fulfil the information requests applicable to its appointment. Agree how records will be retrieved and supplied when MHRA requests them.

The following is a recommended handover package built around those duties and the DORS data requirements. It is not a separate MHRA-mandated dossier template. For each item, record the owner, version or date, receiving contact, access location and any unresolved gap.

Test the package by selecting a product from each registration route and tracing it to its conformity document, technical file and portal entry. Confirm that certificate scope matches the product identity and that the new representative can retrieve the material. Record missing or expired evidence as an open action. A receipt stating that folders were received is weaker evidence than a documented scope and access check.

Give ongoing safety work a separate owner list: who receives new complaints, who forwards them to the manufacturer, who monitors open MHRA requests and who maintains corrective-action communications. Do not limit the archive arbitrarily to three years of vigilance data. Determine the records needed for affected devices and open investigations, and apply the relevant retention requirements and controlled procedures. The appointment change does not end the manufacturer’s post-market responsibilities.

MHRA requires a Great Britain importer to inform the manufacturer or UKRP of its intention to import for placement; the manufacturer or UKRP then submits the importer’s details. Informing importers of the representative change is a useful handover control. Distinguish that practical notification from the specific legal responsibility to keep the regulator’s importer information accurate.

Labels, declarations and conformity-assessment contacts

The binding distinction in MHRA’s labelling guidance is whether UKCA marking has been affixed. Where it has, the UKRP’s name and address must be on the product labelling, outer packaging or instructions for use. This also applies to dual-marked devices. CE-only devices do not require UKRP details on their labels under the current Great Britain guidance. Review the actual marking route for every product rather than assuming the whole portfolio uses one route.

Review declarations and certification contacts for changes that actually affect their content. Do not add a UKRP mandate date to every declaration merely because the representative changed. UK MDR regulation 46 concerns selection of approved bodies for conformity assessment; it does not itself state a universal UKRP-change notification rule. Practical communication with a relevant Approved Body should follow the applicable assessment route, certificate conditions and agreed change-control process.

The current official CE acceptance timelines distinguish directive-based and regulation-based routes. Eligible MDD/AIMDD devices have an outer limit of 30 June 2028, subject to the relevant certificate and transitional conditions; eligible IVDD devices have an outer limit of 30 June 2030. MDR- and IVDR-compliant devices are accepted to 30 June 2030 while continuing to meet their applicable conformity requirements. The routes also have self-declaration and custom-made-device exceptions, so these dates are not substitutes for a product-specific eligibility check.

MHRA launched its consultation on indefinite CE recognition in February 2026, and the consultation page now identifies it as closed. A consultation does not amend the applicable law. Use the current acceptance arrangements for the transfer plan and monitor enacted changes; do not promise that future policy will permanently remove labelling or other domestic obligations.

Keep Northern Ireland and EU representation separate

A UKRP appointment serves the Great Britain requirements. A manufacturer based outside the EU or Northern Ireland needs an authorised representative established in the EU or Northern Ireland for Northern Ireland placements, including when the manufacturer is based in Great Britain. A UKRP change does not itself amend that separate appointment. If one service provider performs both roles, review both mandates and data records rather than assuming one portal action changes everything.

MHRA’s current registration guidance says that, from 28 May 2026, MHRA registration is no longer required for non-custom-made devices for the Northern Ireland market, with EUDAMED becoming the relevant registration system. The European Commission’s EUDAMED overview confirms mandatory use of the first four modules from that date. It also links device and certificate transitional arrangements. Review the applicable device-registration timetable separately; a Great Britain UKRP change is not evidence that an existing EU or Northern Ireland device record has been completed.

Custom-made devices remain outside EUDAMED device registration and must be registered with MHRA within 28 days of being made available on the Northern Ireland market. MHRA distinguishes registrations made by an appointed Northern Ireland representative from those the manufacturer must make where it uses an EU-based representative. Manufacturers outside the UK without a Northern Ireland representative should use MHRA’s published contact instructions. Avoid applying a blanket rule that every custom-made manufacturer registers directly.

Stock decisions and the evidence to keep

MHRA defines placement as the first making available of each individual device for use or distribution on the Great Britain market, whether supplied for payment or free of charge. It is not each later sale of the same unit, and it is not automatically the date a shipment crosses the border. The registration guidance also says registration must be maintained while a device is still made available, and safety obligations continue for devices already on the market.

As a planning exercise, separate three stock groups: units demonstrably supplied before the change; units held by the manufacturer that have not yet been first supplied; and in-transit consignments whose supply status needs verification. Use contracts, delivery and acceptance records, unit or batch identifiers and distribution evidence to establish the facts. A shipping date or warehouse location alone should not decide the result. Check any remaining labelling, registration and safety obligations before authorising supply.

The sources reviewed do not provide a universal UKRP-transfer sell-through period, automatic exemption from relabelling, or blanket assurance that previously shipped stock needs no corrective action. For unresolved consignments or disputed appointment dates, obtain case-specific clarification before release. Treat a hold on new placements during an unregistered interval as a defined control with a named owner and release evidence.

• Keep the appointment documents and agreed end/start dates, together with the relevant termination correspondence and handover acceptance records.

• Retain outgoing unregistration evidence, incoming application references, required payment evidence, MHRA acceptance and the reconciled device register.

• Check the Public Access Registration Database (PARD) where applicable. It shows the manufacturer and representative information, but performance-evaluation IVD registrations are not published there. A public screenshot is corroboration, not device approval.

• Record the affected stock groups, placement evidence, holds, labelling decisions, supply-chain communications and reasons for releasing each group.

• Maintain the open complaints, incidents, corrective actions and regulator-request tracker with responsible contacts before and after the change.

• Set retention periods through applicable regulatory requirements and controlled quality procedures. The five-year designation validity limit is not a default retention rule for this transition file.

Before closing the project, reconcile the incoming registration against the original Great Britain product scope, review the public listing where applicable, and verify that documentation access and complaint routing work. This final comparison catches products omitted from the new application, stale contact details and unresolved tasks that a registration receipt alone would not reveal.

For an unresolved DORS or registration issue, use MHRA’s published registration contact instructions. Prepare the manufacturer’s legal name, outgoing and incoming organisation references, application numbers, relevant dates and a precise description of the problem. These details allow MHRA to address the actual record rather than a hypothetical transfer sequence.