Major Changes to MHRA Medical Device Registration Fees

Part 2 What do Manufacturers and UKRPs Need to Do?

There is a hard stop to the change process, from 1^st April the system will be operable, and the products registered at that point will decide the fees payable for 2026/27. So, there are a number of actions manufacturers and UKRPs will need to consider.

Review the Current Registrations

It is important that manufacturers check their current registrations in DORS, there are several things that will need to be reviewed:-

• Firstly, check that your account is marked as ‘Registered’, if the account is marked as ‘Suspended’, ‘Closed’ or ‘Unregistered’, take immediate action to rectify. Any suspended accounts will be closed on 1^st April 2026. For UKRPs makes sure all manufacturers that you represent are marked as ‘Registered’.
• Manufacturer and UKRP details. Make sure the main contact name and email address are correct.
• Review your registered devices. Unregister any that are no longer manufactured or to be placed on the UK market. Please note that existing stocks of obsolete product can still be sold through after a product is unregistered. Consider registering any new devices that you intend to place on the market, though see below for considerations about timing.
• Review and re-consider the need or appropriateness of dual registration of procedure packs and individual items.
• Check that you do not have any products registered under Obsolete GMDN terms, if so update the registration with the new term.
• Review and where necessary submit Temporary (Draft) Applications as these will be removed at the change over date.

It is important to note that DORS will be inactive from 5pm on 30^th March 2026 for essential updates. The MHRA also caution that the system is likely to be busy in the run up to the change over so early action is strongly recommended.

Checking Your Likely Fees for 2026/2027

The MHRA will provide an annual fee estimate calculator on the Summary page of your DORS account, this will only be available from 1^st April 2026. However, the MHRA will be emailing UK based manufacturers and UKRPs with estimates of the fees prior to the change over, some manufacturers may already have received this information.

To complete your own checks, you will need to identify which Level 2 categories your registered devices fall into. To do this, you will need a Manufacturer’s Registration with GMDN. With this you can search the relevant database.

Timing is Everything As mentioned above, there as some things that need to be done now, especially making sure any obsolete products are removed from the registration. However, if you have major range changes or product launches planned for the coming months, you will need to consider the current costs for making changes, before 1^st April, against the future costs. If the plan is to add products in additional Level 2 GMDN categories you will be charged additional fees for 2026/27, irrespective of whether the changes are made before or after 1^st April, however delaying the amendments until after 1^st April may potentially save on the current registration fees. There is no right or wrong answer, just something to consider for your particular circumstances.