Background

In late 2024 the MHRA opened a consultation on changing its statutory fees. One of the proposals was to introduce an annual renewal fee, calculated at £210 per GMDN code. This was to cover the costs of post-market activities, which are currently mostly paid for by a grant from the Department of Health and Social Care (DHSC).

That idea faced substantial opposition. Manufacturers responded that it would create a new, and disproportionate, cost burden, particularly for SMEs. As a result of the largely negative feedback, the MHRA advised in its March 2025 response that it would not introduce an annual fee at that stage. Instead, it would continue to consider alternative options.

On 2 September 2025 the MHRA returned with an updated consultation outcome. In it, they confirm that an annual fee will in fact be introduced starting April 2026. However, the fee structure will differ from its initial proposal.

The Update

The MHRA’s updated response to the fee consultation is available: HERE

New Fee Structure

Starting 1 April 2026, the MHRA will introduce an annual fee of £300 per level 2 GMDN category. This is to recover the costs associated with their post-market surveillance (PMS) activities.

This new annual fee will 1) replace the current one-time new registration fee, and 2) apply to any company with devices registered in Great Britain, whether UK-based or overseas.

Their original fee proposal was to invoice at the GMDN term level, which is the most granular (sometimes called Level 5). The MHRA will now instead invoice based on broader Level 2 categories (or Level 1, if no Level 2 exists). By using broader Level 2 categories, the MHRA is attempting to apply a ‘fairer’ cost structure, especially for those manufacturers with a large number of registered GMDN codes. The MHRA states:

“We estimate that approximately 60% of manufacturers will only pay a single charge and SMEs are likely to fall into that category as they are likely to have more limited range of products compared with larger companies”.

The MHRA advised they will publish updated guidance to better explain the associated charges. And that the guidance will be accompanied by an indicative bill for every manufacturer with one or more products registered with the MHRA.

How to Find Level 2 GMDN Categories

There are two types of GMDN membership for manufacturers, only one of which gives them access to Level 2 GMDN data:

Therefore, companies with a paid GMDN membership can already start identifying their annual fee exposure, based on their volume of Level 2 categories.

For companies without a GMDN membership, or with only a Basic account, the MHRA has committed to issuing an indicative bill ahead of implementation. This means manufacturers will still know their annual fee liability without needing to pay for a GMDN membership. However, they will need to wait for the MHRA’s indicative bill to see their annual fee amount.

Check How Many GMDN Codes You Have Registered

Manufacturers can easily verify the list of registered GMDN codes via the MHRA’s Public Access Registration Database (PARD).

Enter your company name, and the search results will itemize the registrations. You can also download the list by clicking the “Download CSV” hyperlink.

Manufacturers can review this list to determine if any GMDN codes are not being actively marketed and deregister them before April 2026. 

Timing of the First Annual Payment

The MHRA’s consultation response states the ‘charging year’ will run from 1 April to 31 March. The basis for the fee calculation will be on the GMDN Level 2 categories registered per manufacturer on 1 April 2026. If a new Level 2 category is added during the fee year, the manufacturer could be charged pro-rata for the remainder of that year.

This means the first annual fee will be invoiced after 1 April 2026, covering the full 2026/27 financial year. The exact billing month has not yet been published. Manufacturers should plan for the first payment to become due in the early part of the ‘charging year’.

For non-UK manufacturers, the fee will likely be billed through their UK Responsible Person (UKRP).

Quick Recap

What is changing: From 1 April 2026, the MHRA will replace the one-time initial registration fee with an annual £300 fee per GMDN Level 2 category (or Level 1, where no Level 2 exists).

Who is impacted: All manufacturers with devices registered in Great Britain, regardless of where the company is based.

When: First invoices will be issued after 1 April 2026, covering the 2026/27 financial year.

Action items for manufacturers:

See the sections above for instructions on how to check your registered GMDN codes and identify Level 2 categories.