UKRP Designation Agreement: Sole Status, Mandatory Tasks and Fee Changes

1. Key takeaways

A UKRP must provide written evidence of its authorisation by the manufacturer — the letter of designation. This letter is a legally binding contract: it must state that the UKRP is the sole UKRP for that manufacturer and must set out the mandatory tasks the UKRP will perform on the manufacturer’s behalf. MHRA expects the mandatory tasks named in the letter to be consistent with the official UKRP guidance. Since 1 April 2026, UKRPs and Northern Ireland authorised representatives no longer need to pay a separate fee to upload a new letter of designation. For manufacturers, the letter is more than an upload requirement: it is the single document that defines who is accountable in the United Kingdom, what the appointed party must actually do, and on what terms the relationship can be ended. Getting the wording right at signature avoids corrective requests after DORS upload, protects the manufacturer if the relationship later breaks down, and keeps the registration record aligned with the contract that sits behind it. This article examines the legal basis of the letter, the elements it must contain, the termination mechanics, and the fee changes that took effect in April 2026.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 60 (status of the UKRP); reg 21C.
• The Medical Devices (Fees Amendment) Regulations 2026 (SI 2026/197, made 25 February 2026, in force 1 April 2026): reg 3.
• Official guidance: GOV.UK, Register medical devices to place on the market (the letter of designation must be a legally binding contract declaring sole status and mandatory tasks); MHRA, DORS Fees Guidance — New fee structure from 1 April 2026 (version 3.0): from 1 April 2026, no separate fee is charged for uploading a new letter of designation.

The legal chain runs in two layers. At the first layer, reg 60 and reg 21C establish the UKRP’s status and the appointment requirement itself, which is the reason a written designation is needed at all. At the second layer, the official guidance specifies what a compliant letter looks like: it must be legally binding, it must declare that the signatory is the only UKRP acting for that manufacturer, and it must enumerate the mandatory tasks. SI 2026/197 then adjusts the cost side of the relationship: its reg 3 rewrote the fee provisions of the UK MDR 2002 with effect from 1 April 2026, and the MHRA fees guidance confirms that uploading a new letter of designation attracts no separate charge under the new structure. Manufacturers should keep both layers in view, because a letter that satisfies the contract test but describes duties inconsistent with the official guidance will still be defective in MHRA’s eyes, however carefully it was drafted and signed.

3. Expert insights

Insight 1: the sole-UKRP statement in the letter is a hard requirement. The official guidance requires the letter of designation to state that the UKRP is the only UKRP acting for that manufacturer, and to specify the mandatory tasks it will perform on the manufacturer’s behalf. A letter missing either element may attract a corrective request after it is uploaded in DORS, which delays the registration record and, in the worst case, delays the market entry the registration was meant to support. Drafting practice should therefore check the letter against the official guidance clause by clause before signature: one sentence declaring sole status, one list of mandatory tasks matching the official duty list, and consistent party names and addresses throughout, so that the document maps cleanly onto the DORS organisation record.

Insight 2: the termination mechanism is two-way and carries a reporting duty. The UKRP must terminate the legal relationship where the manufacturer breaches its obligations, and must inform MHRA and, where applicable, the relevant conformity assessment body. This makes termination a regulated event rather than a private commercial matter. The agreement should therefore pre-agree the practical mechanics: the situations that constitute a breach of obligations, a cure period before termination is triggered, and the arrangements for documents and registrations after termination. Without these provisions, a termination forced by the statutory duty can leave the manufacturer with no UKRP, registrations in limbo, and devices on the market whose responsible person has just resigned — a scenario best avoided by contract design rather than improvised in a crisis.

Insight 3: the fee changes have lowered the friction of changing UKRP. Since 1 April 2026, uploading a new letter of designation no longer attracts a separate fee, and changes to the organisation’s name and address are also free. However, changing the UKRP itself remains a chargeable item on the fee table (before 1 April 2026 it was charged per represented organisation). The direction of travel is clear: routine paperwork has been de-charged, while structural changes to the registration still carry a cost. Companies weighing a UKRP change should therefore model not only the residual switch fee but also the practical work of migrating registration data and ensuring continuity of the registration record during the handover period.

4. Practical recommendations

GRZAN recommends that a UKRP agreement cover at least seven items: the scope of the authorisation and its sole status; the list of mandatory tasks, mapped to the eight duties in the official UKRP guidance; custody of, and access to, the technical documentation; the time limit for relaying correspondence from MHRA; the time limits for notifying incidents and complaints; the allocation of fees and liability; and the termination scenarios together with post-termination arrangements. Each item should name a responsible contact and a measurable response time, because a duty without a deadline is difficult to enforce in practice. The agreement should also state the ownership of registration data and a duty to assist with migration — when a UKRP is changed, the hardest obstacle is usually continuity of the historical registration data rather than the contract itself, and a migration clause agreed in advance converts that obstacle into a scheduled task. Keep the signed letter of designation and the agreement aligned in wording, and revisit both whenever the official guidance is updated.

5. Verification checklist

Before uploading the letter of designation in DORS, confirm each of the following items.

• □ The letter of designation contains the sole-UKRP declaration
• □ The mandatory tasks are listed item by item
• □ Time limits for relaying MHRA correspondence and incidents are agreed
• □ Termination scenarios, a cure period and post-termination arrangements are agreed
• □ Ownership of registration data and migration assistance are agreed

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 helps manufacturers entering the United Kingdom market with the full scope of UKRP and fee-budgeting services described above: drafting and signing a compliant letter of designation, managing MHRA DORS registration and account lifecycles, forecasting annual registration fees by GMDN category, and supporting safe UKRP changes with data migration planning. For a consultation on your UKRP agreement or appointment documents, contact us at info@grzanglobal.com.