UK Medical Device Registration Fees from 1 April 2026: The Annual Fee Structure

1. Key takeaways

From 1 April 2026, MHRA device registration fees moved from a one-off model to an annual fee structure: the single registration/change fee rose from £261 to £300, and a new annual maintenance fee of £300 per year was added, charged per GMDN® Level 2 category (or per Level 1 category where no Level 2 category applies). The fee period runs from 1 April to 31 March each year, and the first fee period is 1 April 2026 to 31 March 2027. The legal basis is SI 2026/197 reg 3 (England, Wales and Scotland), reg 4 (Northern Ireland), and reg 5 (custom-made devices in Northern Ireland). The change is more than a price update: it converts registration from a one-time data entry into a continuing obligation with an annual cost and an annual payment discipline, and it ties the cost directly to the number of GMDN categories the portfolio spans. Companies that model their exposure early can clean their registration data before the fee is incurred; companies that do not will pay for categories they no longer need. This article sets out the new structure, the blocking rule, the pro-rating mechanics and the absence of any reductions.

2. Legal basis

• The Medical Devices (Fees Amendment) Regulations 2026 (SI 2026/197): made 25 February 2026, in force 1 April 2026; reg 3 (amends reg 53 of SI 2002/618 — England, Wales and Scotland), reg 4 (amends reg 53 — Northern Ireland), reg 5 (amends reg 7 of SI 2021/905).
• SI 2026/197 reg 3(2)–(7): annual fee of £300; no charge for additional devices in the same category; pro-rating; devices must not be placed on the market unless fees due have been paid; definition of the first fee period; definitions of fee period, GMDN, maintenance and registration category.
• UK MDR 2002 (SI 2002/618, as amended): reg 53 (the original fee provision, whose amount was adjusted to £261 by SI 2025/749 on 16 July 2025).
• Official guidance: MHRA, DORS Fees Guidance — New fee structure from 1 April 2026 (version 3.0).

The drafting history is worth noting because it explains the baseline figures: reg 53 had already been amended once in the previous year, with SI 2025/749 raising the single fee to £261 on 16 July 2025, before SI 2026/197 replaced the one-off model with the annual structure six months later. The new instrument is carefully defined — fee period, GMDN, maintenance and registration category each have statutory definitions in reg 3(7) — and the charging logic in reg 3(2)–(4) sets the annual amount, the same-category carve-out and the pro-rating rule. The separate amending provisions for Northern Ireland (reg 4) and for Northern Ireland custom-made devices (reg 5, amending SI 2021/905) keep the three legal routes aligned on the same £300 figures.

3. Expert insights

Insight 1: reg 53(5) is the most underestimated hard constraint. Reg 53(5), added by SI 2026/197, provides that a person must not place a device on the market unless all fees due under that provision have been paid — and the rule is not limited to fees relating to that specific device. This means that arrears on a single device can block the lawful placing of the entire account’s portfolio. It is the change that upgrades fee compliance from an administrative matter to a market-access condition: an unpaid invoice is no longer a billing nuisance but a potential prohibition on supply. Companies should therefore integrate fee status into shipment release controls, exactly as they integrate registration status, and finance and regulatory teams need a shared view of what is owed and when.

Insight 2: multiple devices in the same category attract only one fee. Reg 53(3) provides that where a person has already incurred the fee for a device, additional devices in the same registration category are not charged (whether registered at the same time or later). The annual cost therefore depends on how many GMDN Level 2 categories the portfolio covers, not on the number of SKUs. A hundred products inside three categories cost three annual fees; three products spread across six categories cost six. This asymmetry makes portfolio structure — which products share categories — a genuine cost lever, and it should be reviewed whenever new devices are added to the range.

Insight 3: mid-period registration is pro-rated. Reg 53(4) provides that where information is provided after the first day of the fee period, the fee is pro-rated by the remaining days. The worked example in the official fees guidance is: £300 ÷ 365 days ≈ £0.82191 per day; registering four categories on 2 April is calculated on 364 days, totalling approximately £1,196.70. The pro-rating rewards prompt registration within a period but also means every new category added mid-year carries its own partial-year charge, which budgeting should anticipate.

Insight 4: the room for reduction is zero. The official fees guidance states clearly that MHRA does not offer fee waivers, SME rates, instalments or payment plans, citing the cost-recovery principles of HM Treasury’s Managing Public Money. The annual charging by category is itself already weighted in favour of smaller portfolios, since the fee does not scale with device count. Budgeting should therefore assume the full £300 per category per year with no discount scenarios, and cost saving should be pursued through portfolio tidiness rather than through negotiation.

4. Practical recommendations

GRZAN recommends that clients do two things immediately. First, calculate the number of GMDN Level 2 categories the registrations cover and use it to forecast the annual fee (categories × £300); this single number is the whole budget driver under the new structure, and it should be tracked as registrations evolve. Second, clean up devices in DORS that are discontinued or for which the product is only being put into service — the official fees guidance notes that, to avoid paying unnecessary charges, you should follow the guidance and pay only for devices that are being manufactured and placed on the market. Removing dormant registrations before the fee period advances prevents paying for categories that no longer reflect commercial reality. In addition, monitor the actual amount due and the payment deadline shown in the DORS account, and route reminders to an owner with authority to pay.

5. Verification checklist

Before the next fee period, confirm each of the following items.

• □ The number of GMDN Level 2 categories covered has been calculated
• □ The annual fee has been estimated (categories × £300)
• □ It has been confirmed that no unpaid fees are blocking market placing (reg 53(5))
• □ Devices that are put into service only and non-self-manufactured devices have been removed from the registration
• □ A reminder for this year’s payment deadline has been logged

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: forecasting annual MHRA registration fees by GMDN category, tidying registration portfolios ahead of the fee period, monitoring DORS payment deadlines, and managing registration data so that no device is paid for unnecessarily. For a consultation on your fee exposure, contact us at info@grzanglobal.com.