Choosing a UK Market Model: Combining the UKRP and Importer Roles

1. Key takeaways

The United Kingdom does not prohibit an importer or distributor from also acting as the UKRP — the official guidance states that nothing prevents an importer or distributor from also acting as the UK responsible person. This opens three optional models for structuring a UK market presence: UKRP and importer separated, UKRP doubling as importer, and a third-party professional UKRP plus an independent importer. The decisive criterion is not cost but the controllability of legal responsibility and the continuity of data. Legal responsibility matters because the UKRP carries eight statutory duties, including the duty to terminate the relationship and notify MHRA when the manufacturer breaches its obligations — duties that can collide with the commercial interests of a trading partner. Data continuity matters because every UKRP change risks breaking the registration record, and under the annual fee structure that record now carries real money. This article evaluates the three models against those criteria and gives a decision framework built on three questions.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 60 (status of the UKRP); reg 7A, reg 19, reg 21A, reg 21B, reg 33A, reg 44 (registration obligations); Part VII reg 59–67 (enforcement).
• SI 2026/197 (in force 1 April 2026): reg 3(5) (devices must not be placed on the market unless the fees due have been paid).
• Official guidance: GOV.UK, Regulating medical devices in the UK and GOV.UK, Register medical devices to place on the market.

The permissibility of combined roles comes from the design of the framework itself: reg 60 defines the UKRP by establishment and function, not by exclusivity against other economic operator roles, and the importer and distributor duties in Part VII likewise do not disqualify an operator from holding the UKRP position. But permissibility is not the same as advisability. The registration provisions and the enforcement Part together define what the UKRP is exposed to: registration accuracy duties, fee obligations under the regime introduced by SI 2026/197, and the blocking rule in reg 3(5) that ties unpaid fees to the loss of the ability to place devices on the market. Any model chosen must be able to carry those exposures, whoever holds them.

3. Expert insights

Insight 1: the UKRP is an accountable role, not a delivery address. Among the UKRP’s eight statutory duties is the duty to terminate the legal relationship where the manufacturer breaches its obligations and to notify MHRA. If the UKRP is also a trading partner — and simultaneously a customer — this duty stands in structural conflict with its commercial interest: the party best placed to police the manufacturer is also the party whose revenue depends on staying on good terms with it. This is the risk point that should be evaluated first when choosing a model, ahead of price comparisons and convenience. The conflict can be mitigated contractually, but it cannot be removed, because the statutory duty applies to whoever holds the role.

Insight 2: the fee structure has changed the magnitude of holding costs. Under the annual fee structure, the cost of holding a UK registration = the number of GMDN Level 2 categories covered × £300 per year, and reg 3(5) of SI 2026/197 provides that arrears block the ability to place devices on the market. This means the strategy of keeping a few extra registrations around just in case is no longer economical: every dormant category now pays an annual fee, and an unpaid fee anywhere on the account can interrupt placing for the whole portfolio. The registration portfolio should be streamlined to the categories that are actually placed on the market, with dormant registrations removed before the fee period advances rather than carried as options.

Insight 3: data continuity is the biggest risk when changing the UKRP. The continuity of the registration history, the PARD records, the conformity documents and the UDI data determines the friction cost of a UKRP change. A change that goes badly leaves devices on the market with a broken record chain — registrations that no longer point to the right responsible person, evidence that is hard to retrieve, and a fee status that must be re-established. The agreement should therefore pre-agree the ownership of registration data and a duty to assist with migration, so that the outgoing UKRP’s obligations are defined before the relationship ends rather than negotiated while the clock is running against market access.

4. Practical recommendations

GRZAN recommends deciding the architecture with three questions. (1) Does the manufacturer have its own establishment in the United Kingdom? If it does, it may act as its own UKRP; if not, it must appoint one. (2) Who performs the import function? If the UKRP doubles as importer, the reporting is simplified; if a third party imports, the notification and submission duties must be performed. (3) Is separation of functions and liability needed? Where a trade partner acting as UKRP would create a conflict of interest, an independent third-party UKRP is preferable. The three models differ in agreement wording, DORS operations and fee calculation, so the architecture should be settled before registration is started: changing models later means re-papering the designation, re-drawing the importer notification chain and re-testing the fee mapping. Document the decision with the reasoning, since it will guide every subsequent agreement and system change.

5. Verification checklist

Before fixing the market model, confirm each of the following items.

• □ It has been decided whether the UKRP and the importer are separated
• □ The conflict of interest of a trade partner doubling as UKRP has been assessed
• □ Ownership of registration data and migration assistance have been agreed
• □ The registration portfolio has been streamlined to the categories actually placed on the market
• □ The annual holding cost has been estimated (categories × £300)

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: evaluating UKRP and importer structuring models, acting as an independent third-party UKRP, planning registration data migration, and forecasting annual holding costs by GMDN category. For a consultation on your UK market architecture, contact us at info@grzanglobal.com.