The MHRA have issued the revised DORS Fees Guidance to reflect the implementation of the revised fee structure being implemented from 1st April 2026.
We have extracted the key sections from the updated MHRA product registration webpage for members below.
Fees from 1 April 2026
A new fee is planned to come into effect on 1 April 2026 and will apply for the financial year 2026-27. It will replace the current one-off registration fee regime.
Manufacturers will be charged annually based on how many Level 2 GMDN® Categories their devices are registered under. If multiple GMDN® and products are registered under the one Level 2 Category, they will only be charged once per year for that Level 2 GMDN®Category. Some products fall under more than one Level 2 GMDN® Category, and these will also only be charged once per a year.
For registrations made within the charging period, 1 April to 31 March, the annual fee will be payable for the registration on a pro rata basis.
Calculation of each manufacturer’s 2026/27 fee will be based on the Level 2 GMDN® Categories that their registrations fall under on 31 March 2026.
The estimated unit cost for the fee from 1 April 2026 will be in the region of £300 per year, per Level 2 GMDN® Category.
Please see the updated government response to the MHRA consultation on statutory fees for further information on the new fee structure.
In preparation for the new fee, it is important that customers review their registration account to ensure all data is correct.
In particular please check and update the following, as necessary:
- Registration Status of Account – if your account is currently suspended, please see Review registration
- Main Contact email address
- Organisation address
- All registered devices and products
- Remove any ‘Pseudo’ GMDN® that were migrated from our previous DORS system. These are not valid registrations and will be removed from DORS on 31 March 2026
Please see Making changes to your registration for further information on chargeable and free of charge changes.
Preparing for the implementation and management of the new device registration fee
The MHRA have prepared further implementation and management guidance to help you prepare for the introduction of the new fee from 1 April 2026.
Review registration
You should review your registration frequently to make sure it is up to date. It is a legal requirement to inform the MHRA of any changes to your registration per regulations 7A (general medical devices) and 19 (custom-made general medical devices), regulations 21A (active implantable medical devices) and 21B (custom-made active implantable medical devices), and regulations 33A (in vitro diagnostic medical devices) and 44 (in vitro diagnostic self-testing devices) of the Medical Devices Regulations (2002) (SI 2002 No 618) (as amended) concerning registration of persons placing medical devices on the Great Britain or Northern Ireland markets, as and when they occur. Please do not wait for reminder emails.
Until 30 March 2026
The MHRA have implemented a renew registration process as a reminder to review your registration and confirm that it is up to date. The first renewal date is 1 year after account request was completed by the MHRA, and then at least every 2 years. You will receive automated email reminders 3, 2 and 1 month before your renewal date – you can review and submit the renew registration application from 3 months before the renewal date. There is currently no fee for this application.
If you do not review your registration and submit the renew registration application on or before 30 March 2026, your account will be suspended. Suspended accounts are removed from the Public Access Registration Database (PARD) and you will not be able to add new devices or order certificates of free sale until you have reviewed your registration and submitted the renewal application.
Review organisation details and all registered devices and products and take the necessary action to ensure the data is correct and up to date. Follow the manage registered devices instructions in the Device registration reference guide and watch the video tutorial for steps on how to review your devices and take any necessary action. This includes uploading new conformity documents, adding or removing products, adding devices, or removing devices (that you no longer manufacture, or migrated devices with Pseudo Global Medical Device Nomenclature (GMDN®), where applicable).
Update any data fields that were not previously populated by following the update registered devices and products instructions in the Device registration reference guide and watch the video tutorial. In particular they urge you to provide the UDI-DIs for your devices (where applicable) as these will be crucial for monitoring and ensuring patient safety.
If any changes need to be made to organisation details or new devices need to be added to your registration/s these are separate transactions that incur the statutory fee per application. Note that if your organisation name and/or address has changed you must update these before renewing your registration. You cannot do this in the renew registration application. Follow the instructions for editing organisation details in the Account management reference guide. The fee is payable.
If no changes need to be made, you will not currently be charged for this review. Follow the renew registration instructions in the Account management reference guide and watch the renew registration video tutorial.
Any device registration accounts that remain suspended at 17.00 on 30 March 2026 will be closed. If you wish to place medical devices on the market on or after 1 April 2026 you will need to create a new account and register all devices again under the new fee structure.
From 1 April 2026
The Renew registration function will be removed from DORS on 1 April 2026. You will still be required to review your registration frequently to make sure it is up to date, in order to meet legislation requirements, and to enable correct calculation of fees.
Making changes to your registration
A statutory fee will be payable from 1 April 2026 for changes to the following:
- adding devices to your registration record or the registration record of manufacturers you represent, that do not fall under a Level 2 GMDN® Category that already exists on the account
- changing device characteristics, for example, incorrect GMDN® assignment, class, from non-sterile to sterile or v.v., trade/brand name, UDIs or any field that cannot be updated in DORS – the device will need to be re-registered. The fee will be payable for new Level 2 GMDN® Categories
- changing status of an IVD, for example a change from ‘performance evaluation’ to ‘new’ – you will need to register the IVD device again. No fee will be payable if the GMDN® Category of the new registration remains the same as the ‘performance evaluation’ registration
- changing the legislation of a device (for example, from MDD/AIMD/IVDD to UK MDR 2002 part II,III or VI, or to MDR/IVDR, a new registration is required. No fee will be payable if the GMDN® Category of the new registration remains the same as the existing registration under different legislation
- change of UK Responsible Person, a new registration is required
- adding new/additional represented manufacturers
You will not be charged the statutory fee for changes to the following on or after 1 April 2026:
- address
- company name
- uploading new letter of designation for represented manufacturers
You will not be charged the statutory fee for changes to the following, either before or after 1 April 2026:
- submitting the renew registration application – this function will be removed from DORS on 1 April 2026, please see Review registration
- updating contact details including email address, telephone numbers, customer service contact telephone number and/or email address
- adding products (medical device name/trade name, model/ version, catalogue/reference detail, UDI-DI, for example) to registered devices
- removing devices or products from your registration record (that you no longer manufacture, or migrated devices with Pseudo Global Medical Device Nomenclature (GMDN®), where applicable)
- updating registered device and product fields that were not populated at time of registration
- updating obsolete Global Medical Device Nomenclature (GMDN®)
- uploading and linking new conformity assessment and self-certification declaration documents to registered devices, providing the documents are consistent with the legislation that the device was originally registered under (if you wish to change the legislation, for example, from MDD/AIMD/IVDD to UK MDR 2002 part II,III or VI, or to MDR/IVDR, a new registration is required and the statutory fee will be payable unless the GMDN® Category of the new registration remains the same as the existing registration under different legislation)
- unregistering your account or the accounts of represented manufacturers that you no longer represent
- adding or deactivating importers
