RegulatoryGuideline · final

MHRA updates device registration guidance with 2026/27 annual fee information

🇬🇧 MHRA · Fri 16 Oct 2026

The UK regulator revised the Fees section of its medical device registration page on 16 October 2026, the latest in a year of changes to the registration regime.

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on registering medical devices for Great Britain and Northern Ireland on 16 October 2026. The change updates the 'Fees' section with information on annual fees for 2026/2027. The page's change log does not set out the figures, so manufacturers should consult the guidance directly.

The update follows a year of changes to the registration framework. A new fee structure took effect on 1 April 2026, when the MHRA also removed the Renew Registration process and dropped some fees for making changes to a registration. An update of 10 April 2026 reflected the removal of fees for changing an organisation's name and address and for uploading a new Letter of Designation.

The agency also moved the deadline for annual fee payment in 2026. A 26 June 2026 entry says the deadline was extended to 31 July 2026. Earlier, on 16 July 2025, the statutory registration fee rose to £261.

Other recent entries cover operational and Northern Ireland changes. The Account Management tab has been removed from the Device Online Registration System (DORS), and all actions are now taken from the Agency Services tab. A 20 February 2026 entry flagged changes to registration requirements for Northern Ireland effective 28 May 2026. From 23 February 2026, the medical device brand or trade name is displayed on the public register of manufacturers.

On 20 July 2026 the MHRA added a clarification concerning devices that are put into service only.

What it means for your team

  • Check the revised Fees section to confirm the 2026/2027 annual fees that apply to your registered devices, and budget and schedule payment accordingly.
  • Update internal DORS procedures, because account management actions are now taken from the Agency Services tab and Renew Registration no longer exists.
  • Northern Ireland registrants should review the requirements that took effect on 28 May 2026 and the separate Northern Ireland fees section.
  • Check that the brand or trade name and GMDN information held for your devices is accurate, as the brand or trade name now shows on the public register.

Official guideline text: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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