UK MedTech: MHRA proposes material changes to medical-device fees from April 2027

On 17 August 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) opened a consultation on proposed amendments to its statutory fees, with implementation proposed from 1 April 2027. The consultation closes at 11:59pm on 25 September 2026. All figures outlined below are therefore proposals and remain subject to the consultation outcome and subsequent legislation.

For medical-device manufacturers and UK Responsible Persons, the proposed increase to the annual post-market surveillance (PMS) registration fee is likely to be of particular relevance. The fee would rise from £300 to £511, representing an increase of approximately 70 per cent.

The practical impact will depend less on the headline amount than on the structure of an organisation's registered portfolio. For relevant Great Britain registrations, the annual fee is charged per chargeable GMDN Level 2 category, or per Level 1 category where no Level 2 category exists, rather than per individual device. Accordingly, multiple devices within the same chargeable category should not in themselves result in additional annual category charges.

The impact may therefore be limited for organisations with a focused portfolio. By contrast, manufacturers with products spanning a substantial number of chargeable GMDN categories may face a significantly higher recurring cost. The MHRA notes that a previous government response estimated that approximately 60 per cent of manufacturers would pay only one charge; the effect on larger and more diversified portfolios is likely to differ materially.

This proposal gives registration-data governance a more direct financial dimension. Before the proposed implementation date, organisations should ensure that their records accurately reflect the products that continue to be placed on the Great Britain market and understand how their active portfolio maps across chargeable GMDN categories. This should not be viewed as an exercise in selecting codes to reduce fees: classification and registration information must remain technically and regulatorily accurate. It is, however, a further reason to maintain complete, current and well-governed registration data.

MHRA guidance is clear that registration must be maintained while a device continues to be made available on the GB market. Where a device has been discontinued and no further product is being placed on that market, registration is no longer required. Post-market surveillance and vigilance obligations for devices already on the market nevertheless continue.

The MHRA also proposes to retain a phased approach to funding PMS activities. While full cost recovery had previously been envisaged for 2027/28, the consultation proposes continuing partial government subsidy during 2027/28 and 2028/29. The proposed £511 fee includes the 8.93 per cent standard indexation increase and reflects a continued partial government subsidy of £8.45 million for that period.

Other proposed changes of note include the following:

The proposed £2,245 fee for a Device Regulatory Advice meeting is unlikely to determine the viability of a regulatory programme. It does, however, reinforce the value of careful preparation. Companies should consolidate questions, focus on decisions that genuinely require MHRA input and address matters that can already be resolved through applicable guidance. This is particularly relevant because the consultation also envisages a more structured advice offering, including a route for simpler non-scientific regulatory queries.

The proposed removal of the separate high- and low-risk amendment fees for clinical investigations is also noteworthy. In the proposed fee table, both are identified as obsolete and scheduled for deletion.

Implications for industry

Organisations with a Great Britain device portfolio should consider incorporating the proposed fees into market-access and lifecycle-management budgets now. A structured review should establish which registrations remain active, whether discontinued products have been appropriately deregistered, and how active devices are distributed across chargeable GMDN categories. Any resulting changes must be evidence-based and remain fully aligned with the applicable registration, classification and post-market obligations.

The broader message is straightforward: accurate and current registration data is not only a compliance requirement; it is increasingly a recurring cost consideration.

Important: The proposed fees are not final. The consultation is open until 25 September 2026, and implementation is proposed from 1 April 2027.