September “In All Other News”: EU Borderline & Classification Manual Updated, and more
3 October 2025
Four New European Harmonized Standards Published Under the MDR
20 October 2025Background
Last month, the MHRA advised they will begin charging annual registration maintenance fees starting April 2026. The purpose is to help recover costs related to the MHRA’s post-market surveillance activities.
As a refresher, the new annual fee structure is:
- £300 per level 2 GMDN category (or level 1, where no level 2 exists) – see image below.
- Covering each 1 April to 31 March fiscal year.
- Applicable to all manufacturers with devices registered with the MHRA.
- Replacing the initial one-time registration fee, which will no longer apply from 1 April 2026.
- Due on a pro-rated basis for devices registered mid-fiscal year.
- Billed through the UK Responsible Person, if the manufacturer is located outside of the UK.
The Update
The MHRA has:
2026 -2027 Estimated Fee Notices
The MHRA will begin sending estimated fee emails starting November 2025. These will be sent in batches, starting with the manufacturers that have the highest volume of registered devices.
The above is the estimate based on the volume of registrations at that time. It is subject to change, as the final fee will be based on the number of Level 2 GMDN codes registered as of 31 March 2026.
March 2025 Logistics
Items to note:
- All TEMP applications will be permanently removed from the Device Online Registration System (DORS) after 5:00 pm on 30 March 2026. Once removed, these cannot be reinstated. If you need to submit an application after this date, you will need to create a new one from 1 April 2026.
- DORS will be unavailable from 5:00 pm on Tuesday 30 March 2026 – Wednesday 31 March 2026. It will be live again starting 1 April 2026. Therefore, complete any required actions before this time.
- UK-manufacturers and UKRPs: ensure the name and email address for your main contact is current; the MHRA will send the estimated fee to this person’s attention.
- All current registration processes must be maintained, even if they will change starting 1 April 2026, e.g., if a device is subject to renewal before 30 March 2026, it must be renewed in DORS to remain active.
Ongoing Fee Estimation
Starting 1 April 2026, an annual fee estimate calculator will be available in your Device Online Registration System (DORS) account. The estimated annual fee will update automatically if impacting changes are made, e.g., you register or de-register chargeable Level 2 GMDN entries.
Paying the Annual Fee
The MHRA will introduce a new method for collecting annual fees:
- From 1 April of each year, a ‘Pay annual fee’ link will appear in the top right-hand corner of the Summary page of each DORS account.
- From there, users may click the link to access the payment page.
- The fee must be paid in full, within 90 days from 1 April of each year. Installment payments are not available, and failure to pay will result in your account being suspended.
- Only the following organizations can make payments to the MHRA: UK-based manufacturer accounts, UK Responsible Person (UKRP) accounts, and Northern Ireland Authorised Representative accounts.
- Once payment is made, you will receive an automated email with a paid invoice (PDF) attached. A pro-forma invoice can be downloaded via the ‘Pay annual fee’ link.
- Starting 1 April 2027, automated annual fee reminders will be sent to the main contact: 90, 60, and 30 days before the payment is due.
Note that this process is still under development; the above is subject to change.
GMDN Codes
The GMDN categories will remain fixed for the MHRA’s full charging period (1 April to 31 March). The MHRA will reset and refreeze the codes from 1 April of each year.
This means that, if a code is modified by the GMDN Agency during that period, the information between the GMDN Agency’s database and the MHRA’s database may differ.
