DORS Registration Changes, Account Closure and the End of Renewal

1. Key takeaways

From 1 April 2026, the DORS Renew registration function has been removed, but the statutory duty to review registration information continues. The fee rules now work in tiers: changes to the organisation’s name and address, uploading a new letter of designation, uploading conformity documents, and removing discontinued products — free; adding devices that fall into a new Level 2 GMDN category, and changes to device characteristics (GMDN assignment errors, classification, sterile status, brand name, UDI and other changes that require re-registration) — chargeable. Two dates also matter for legacy accounts: original Great Britain authorised representative accounts that had not been updated to the UKRP role by 30 March 2026 have been closed, and accounts that had not completed their renewal review by that date have also been closed. Together these changes mark the end of the old renewal cycle: keeping a registration current is now a continuous review discipline rather than an annual system prompt, and the fee consequences of a change now depend on what kind of change it is. This article sets out the closure rule, the surviving review duty and the notification duty.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 7A and reg 19 (general devices), reg 21A and reg 21B (active implantable medical devices), reg 33A and reg 44 (IVDs) — the statutory duty to notify MHRA when changes occur.
• The Medical Devices (Fees Amendment) Regulations 2026 (SI 2026/197, in force 1 April 2026): reg 3.
• Official guidance: GOV.UK, Register medical devices to place on the market (the Making changes to your registration section); MHRA fees guidance, version 3.0.
• Key dates: legacy Great Britain authorised representative accounts not updated to the UKRP role before 30 March 2026 have been closed; accounts that did not complete the renewal review by that date have also been closed.

The notification duty has always been there: each of the registration provisions listed above obliges the duty holder to keep MHRA’s record accurate as circumstances change, and the enforcement framework backs that duty up. What changed in 2026 is the operational layer around it. SI 2026/197 rebuilt the fee provisions so that changes are charged by type — data corrections and paperwork updates pass free, while anything that changes the registration category or the device’s registered characteristics is a new chargeable event. The guidance operationalises both layers and adds the deadline discipline: the 30 March 2026 cutoff for updating authorised representative accounts to the UKRP role and for completing renewal reviews, with closure as the consequence of inaction.

3. Expert insights

Insight 1: account closure is irreversible. The official guidance records that registration accounts still suspended as of 17:00 on 30 March 2026 have been closed; if devices are to be placed on the market on or after 1 April 2026, a new account must be created and all devices re-registered under the new fee structure. This means historical registration records and fee continuity can be broken: a closed account does not carry its history forward, and the re-registration exercise is effectively a fresh start with new data entry, new evidence uploads and new fee triggers. Companies discovering a closed account should treat recovery as a project with an owner and a deadline, not an inbox item, because devices cannot lawfully be placed until the new account is complete.

Insight 2: removing the renewal function does not remove the review duty. The official guidance is explicit: even though the Renew function was removed from DORS on 1 April 2026, registration information must still be reviewed regularly to keep it up to date, in order to meet the legal requirement and ensure the fees are correctly calculated. The system no longer prompts the review, but the law still expects it — and under the annual fee structure an out-of-date registration is not just a compliance defect but a fee-calculation defect, since charges follow the categories and characteristics on record. Companies should turn the review into an internal calendar item with a named owner, rather than relying on a system reminder that no longer exists.

Insight 3: notifying changes is a statutory requirement. The official guidance cites reg 7A, reg 19, reg 21A, reg 21B, reg 33A and reg 44 (for Great Britain) and reg 7 of SI 2021/905 (for Northern Ireland) in requiring MHRA to be notified when changes happen — do not wait for a reminder email. The instruction cuts against the habits formed under the old renewal cycle, where annual prompts set the rhythm. Under the new regime the rhythm belongs to the company: a change in address, contacts, device characteristics or product status should trigger a same-day decision on whether a free update or a chargeable re-registration applies, followed by prompt submission.

4. Practical recommendations

GRZAN recommends establishing a quarterly DORS account review calendar that checks six fixed items: the account status (active, suspended or closed), the primary contact email, the organisation address, all registered devices and products, the GMDN categories and UDI-DI data, and the fee payment status. Any change should be submitted immediately after it occurs, without waiting for reminders, and the reviewer should classify each change in advance as free or chargeable using the tiered fee rules. For accounts that have already been closed, rebuild promptly under the new structure and check the resulting PARD records against the historical portfolio, so that nothing drops out of the public registration record during the transition. Keep dated records of each quarterly review — they demonstrate the continuous review discipline the guidance expects and provide the audit trail if MHRA later queries the currency of the data.

5. Verification checklist

At each quarterly review, confirm each of the following items.

• □ The account status has been confirmed as active (not suspended or closed)
• □ A quarterly review calendar and responsible owner are in place
• □ Name/address changes have been processed free of charge
• □ Fees for new device categories and characteristic changes have been assessed
• □ Discontinued devices have been removed from the registration

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: managing DORS account lifecycles after the end of the renewal cycle, classifying changes as free or chargeable, recovering closed accounts under the new fee structure, and forecasting annual registration fees by GMDN category. For a consultation, contact us at info@grzanglobal.com.