MHRA Introduces New Device Registration Fee: What Manufacturers Need to Know

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its “DORS Fees Guidance 2.1”, introducing a new annual fee model for device registration. (assets.publishing.service.gov.uk)

From One-Time to Annual Fee

Until 31 March 2026, MHRA continues to apply the existing £261 one-off registration fee.
From 1 April 2026, a recurring annual fee will replace the one-off fee, based on the number of chargeable GMDN® Level 2 categories (or Level 1 if Level 2 is not defined).
Fees will apply per category rather than per device, with pro-rata charges for new devices added mid-year.

Fee Calculation and Payment

Annual fees are estimated at around £300 per GMDN category.
MHRA will base fees on a snapshot of registered categories on 31 March each year.
Payment is due within 90 days of invoicing, and non-payment may suspend registration access.

Changes and Exemptions

Updating Letters of Designation, organisation name, or address will no longer incur fees.
Re-registering devices in previously paid categories will not trigger additional charges.
Only registration of new devices in chargeable categories triggers fees.

Preparing for the New System

Manufacturers and UK Responsible Persons should:

Review device portfolios and ensure correct GMDN® category assignments before 30 March 2026.
Verify contact and company information in the MHRA DORS system.
Plan for the annual payment cycle, starting from 1 April 2026, and budget accordingly.

The shift to an annual fee model supports enhanced post-market surveillance, sustainable regulatory oversight, and encourages accurate device registrations.

Source: MHRA