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

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:

1. Review device portfolios and ensure correct GMDN® category assignments before 30 March 2026.
2. Verify contact and company information in the MHRA DORS system.
3. 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