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.
MedNet EC-REP
Author
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
Related Articles
MHRA Device Registration: New Clarification on "Placing on the Market" and "Putting into Service" (Update 20 July 2026)
MHRA clarifies medical device registration: 20 July 2026 update explains "placing on the market" vs. "putting into service" in GB.
EC REP Becomes EU REP: What the New Authorised Representative Symbol Means for Medical Device Manufacturers
In short: On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European Union (OJEU) for both the MDR and the IVDR. This amendment replaces the long-standing "EC REP" symbol with "EU REP" for the authorised representative in the European Union. The change is purely editorial, and you have a five-year transition period - until 17 June 2031 - during which both symbols remain valid.
New swissdamed registration fees - what manufacturers need to know from 2027
From 1 July 2026, all medical devices placed on the Swiss market must be registered in the national swissdamed database. Together with this registration obligation, the Swiss Federal Council has approved a revised Swissmedic fee ordinance introducing a product registration fee. The first invoices will be issued in January 2027. Here is what to expect.
Stay Updated
Get the latest regulatory updates and industry insights delivered to your inbox.
Subscribe to Updates