UK MHRA Medical Device Registration Update 2026: New Fees

On 16 January 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance “Register medical devices to place on the market,” setting out revised requirements for registering medical devices in Great Britain and Northern Ireland. The update replaces earlier guidance issued in December 2020 and confirms the introduction of new annual medical device registration fees, effective 1 April 2026.

This change marks a significant shift from the current one-off registration fee model to a recurring annual fee structure linked to Level 2 GMDN® Categories.

What Has Changed in the MHRA Guidance (January 2026)

The updated guidance consolidates earlier MHRA communications and formalises the device registration fee changes previously outlined in the MHRA’s October 2025 publication, “Preparing for the implementation and management of the device registration fee.”

Key changes include:

• Introduction of annual registration fees

• Fees calculated per Level 2 GMDN® Category

• Charges applicable to updates or changes to existing registrations

• Confirmation that all payments must be made via DORS

New MHRA Device Registration Fees From 1 April 2026

Overview of the New Fee Structure

Manufacturers will now be charged annually, based on the number of Level 2 GMDN® Categories under which their devices are registered, rather than per individual device or one-time submission.

Impact of GMDN® Categorisation on Fees

Under the revised MHRA guidance:

• Each Level 2 GMDN® Category attracts a separate annual fee

• Devices grouped under the same Level 2 category incur one fee

• Devices registered across multiple Level 2 categories incur multiple fees

This makes accurate GMDN® classification a key cost-control consideration for manufacturers with broad or complex portfolios.

Charges for Changes to Existing Registrations

Manufacturers should note that the MHRA has clarified that:

• Updates or changes to existing device registrations

• Corrections to manufacturer, device, or regulatory details  

may be subject to a statutory fee, even if no new device is being added.

This reinforces the need for:

• Accurate initial submissions

• Controlled internal change management

• Regular portfolio and registration reviews

Use of the Device Online Registration System (DORS)

The MHRA has reiterated that:

• All device registration applications

• All registration updates

• All fee payments

must be made exclusively through the Device Online Registration System (DORS).

Manufacturers are advised to:

• Review current DORS registrations

• Confirm GMDN® alignment

• Ensure internal teams understand the new annual payment obligations

Impact on Manufacturers and UK Market Access

These changes affect:

• UK manufacturers

• Overseas manufacturers selling into Great Britain or Northern Ireland

• UK Responsible Persons (UKRPs) supporting registrations

The shift to annual fees introduces:

• Ongoing compliance costs

• Greater importance of portfolio rationalisation

• Increased scrutiny of registration accuracy

Failure to budget or plan for these fees may disrupt UK market continuity.

Recommended Actions Before 1 April 2026

Manufacturers should now:

• Review all existing MHRA device registrations

• Verify Level 2 GMDN® Category assignments

• Assess annual fee exposure across portfolios

• Plan budgets for recurring registration costs

• Ensure DORS user access and payment processes are in place

Early preparation will help avoid delays, unexpected costs, or registration lapses.

Internal Reference

• MHRA UK Medical Device Registration & Approval

External References

• MHRA Guidance – Register medical devices to place on the market (Update History)

• MHRA DORS Fees Guidance v2.1 (PDF)
  

‍

‍