UK MHRA DORS Annual Fees: Payment Due 6 November 2026

On 16 October 2026, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) updated its statutory guidance Register medical devices to place on the market to confirm that it has completed the 2026/2027 Annual Fee recalculation exercise on the Device Online Registration System (DORS). Revised fee balances excluding devices that are "put into service only" are now displayed in DORS, and any outstanding 2026/2027 Annual Fees for devices placed on the market must be paid by 6 November 2026, after which accounts with unpaid fees will be suspended.

Background: The 2026/2027 Annual Fee Regime and "Put into Service Only" Exclusion

Under Regulation 53 of the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) and Regulation 7(5) of the Medical Devices (Northern Ireland Protocol) Regulations 2021, the MHRA replaced its previous one-off registration application fee and DORS "Renew registration" function on 1 April 2026 with a recurring annual fee structure detailed in its DORS Fees Guidance (April 2026):

• Annual unit cost: £300 per year per GMDN® Level 2 Category (or Level 1 Category where no Level 2 Category exists) for the charging period from 1 April 2026 to 31 March 2027, calculated against the GMDN® categories held on a manufacturer's registration record as of 31 March of each year.
• In-year pro rata calculation: New chargeable GMDN® categories registered during the charging year are billed pro rata at £300 divided by 365 days (approximately £0.82191 per day), multiplied by the remaining days until 31 March. DORS rounds the total fee to the nearest penny; it does not first round the daily rate to £0.82.
• Northern Ireland scope: Since 28 May 2026, non-custom-made devices placed on the Northern Ireland market must be registered on the European Database on Medical Devices (EUDAMED) and no longer require mandatory MHRA registration; only custom-made devices require ongoing mandatory MHRA registration within 28 days of being made available in Northern Ireland. Page 22 of the fees guidance distinguishes full-year custom-made-device charges from charges for mandatory non-custom-made-device registrations only up to 27 May 2026. Voluntary MHRA registration of non-custom-made devices from 28 May remains chargeable on a pro rata basis to 31 March 2027.

Following the 1 April 2026 rollout, the MHRA published Guidance on the registration requirements for medical devices placed on the market and put into service on 20 July 2026 to address devices that are manufactured and used in-house without commercial distribution:

To exclude "put into service only" devices from the 2026/2027 billing cycle, the MHRA introduced a dedicated "Put into service only" tick box in DORS and gave organisations until 11 September 2026 to update their registration records. Where an organisation both places devices on the market and puts devices into service under the same GMDN® Category, the £300 category fee remains payable. In addition, marking a registered device as "Put into service only" in DORS is irreversible on that record—it cannot be changed back to "Placed on the market" without unregistering and re-registering the device.

Key Requirements for the 6 November 2026 Payment Deadline

With the recalculation exercise now complete as of 16 October 2026, account holders must review their DORS balances and complete payment by 6 November 2026 in accordance with the DORS Fees Guidance and the MHRA Account Management Reference Guide:

1. Who can submit payment: Only UK-based manufacturers, UK Responsible Persons (UKRPs), and Northern Ireland Authorised Representatives can pay fees in DORS. UKRPs and Northern Ireland Authorised Representatives are responsible for collecting applicable fees from their represented manufacturers and submitting payment through the "Annual fee" link on the DORS account Summary page.
2. Permitted payment methods: Full payment (instalments are not accepted) must be made exclusively inside the DORS portal via Worldpay or BACS/CHAPS (external MHRA payment portals must not be used). When paying by BACS/CHAPS, the payer must upload proof of payment before submitting the application and include the unique reference number generated on the DORS payment page in the bank transfer reference field; omitting this reference can delay payment reconciliation and trigger account suspension.
3. Consequences of non-payment after 6 November 2026:
   • Account suspension: Accounts with unpaid 2026/2027 Annual Fees after 6 November 2026 will be suspended. If a UKRP or Northern Ireland Authorised Representative fails to pay, the accounts of represented manufacturers are also suspended.
   • Registration and market-access consequences: Suspended accounts are removed from the Public Access Registration Database (PARD) and cannot order Certificates of Free Sale (CFS) or add new devices. MHRA states that a suspended registration prevents lawful placement on the UK market through that registration; this concerns devices for which MHRA registration is required and should not be read as replacing the separate Northern Ireland/EUDAMED framework.
   • Permanent account closure on 31 March: Any DORS account that remains in "Suspended" status on 31 March of each year is automatically and permanently closed; the next annual cutoff after this payment deadline is 31 March 2027. Closed accounts cannot be reinstated; resuming UK market supply requires opening a new DORS account, re-registering all devices, and paying new statutory fees.

(Note: While the MHRA's 20 July 2026 guidance stated that refunds would be issued where an organisation had already paid the 2026/2027 fee for a GMDN® category consisting solely of "put into service only" devices, the 16 October 2026 update on the main registration guidance page addresses revised unpaid balances in DORS and does not specify a separate refund disbursement schedule.)

Pure Global analysis: Overseas manufacturers should reconcile the revised balance with their UK Responsible Person or Northern Ireland Authorised Representative, identify which categories remain chargeable, and obtain the DORS payment confirmation and paid-invoice PDF before 6 November 2026. The permitted account holder must submit the payment; a manufacturer-to-representative transfer alone does not settle the DORS balance. Where one GMDN® category contains both marketed and service-only devices, plan for the category fee rather than assuming the whole category is exempt. The UK Responsible Person guide explains the representative's wider role.