MHRA Annual Registration Fees: Important Update for Custom-Made Dental Device Manufacturers

Following queries from a number of our members, the DTA has contacted the MHRA to clarify the new annual registration fee arrangements that came into effect on 1 April 2026. 

Registering new devices to your account

The new annual fee structure, introduced on 1 April 2026, replaces the previous one-off fee for registering new devices. If you need to register a new custom-made device part way through the annual fee period, the MHRA has confirmed that charges are now based on GMDN Level 2 categories, rather than individual devices.

If you register a new device within a GMDN Level 2 category that is already registered on your DORS account, there is no additional charge.

However, if you register a device in a new GMDN Level 2 category that is not already associated with your account, a fee will be payable. This is charged at £300 per Level 2 category, calculated on a pro-rata basis depending on when the category is added during the annual fee period (1 April to 31 March).

For example, the MHRA has advised that registering a new Level 2 GMDN category at the current point in the charging year would cost approximately £220. Registering two new categories would therefore cost approximately £440.

Annual fee invoices

We have also received a number of enquiries from members who had received an initial fee estimate but were concerned that they had not received a final invoice.

The MHRA has confirmed that it is not issuing final invoices.

Instead, manufacturers are required to complete the annual fee process within their DORS account, where the final fee can be viewed and payment made. This process is explained from page 12 of the MHRA's Account Management Reference Guide.

The MHRA has advised that manufacturers should complete this process before 31 July to avoid their account being suspended.

If you have been waiting for a final invoice before making payment, you should instead log in to your DORS account and complete the annual fee process.

If you have any questions about your registration or are unsure which GMDN Level 2 categories apply to your devices, please contact the MHRA via email Device.Registrations@mhra.gov.uk