MHRA Consultation 2026: The Fee Increases Coming for Medical Device Manufacturers in 2027

On 17 August 2026, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) opened a public consultation on proposed fee increases. The changes affect virtually every manufacturer with medical devices registered in the UK through a UK Responsible Person. Proposal 6 of the consultation is the one that matters most here, as it concerns the annual post-market surveillance fee, and anyone who wants to have a say has only until 25 September 2026 to respond.

What the MHRA consultation proposes

The MHRA generates around 80 % of its income through statutory fees charged for its services, which it regularly reviews against the actual cost of delivery. Following the last update in 2025, the current proposal contains several elements: a general indexation increase applied to the majority of fees to offset rising staff and operating costs, alongside targeted increases, in some cases considerably higher, for a smaller number of higher-value services requiring additional investment in capacity and digital infrastructure.

The agency also plans firmer service standards with guaranteed turnaround times and rebate arrangements for selected services, expanded support for small and medium-sized enterprises, and improvements to its scientific advice offering. A wider range of individual fees is also set to be adjusted to more accurately reflect the actual cost of delivering each service.

The post-market surveillance fee is set to rise by 70 %

One point is particularly relevant for manufacturers of medical devices and IVDs: the proposed phased increase to the post-market surveillance (PMS) fee. This fee is charged annually per registered GMDN Level 2 category (Global Medical Device Nomenclature) and was introduced in April 2026 on a part-subsidised basis. Under Proposal 6 of the consultation, the fee would rise from £300 to £511 per category (an increase of 70 %) from 1 April 2027. Notably, the MHRA is proposing to continue partially subsidising the fee through 2027/28 and 2028/29 rather than moving straight to full cost recovery, specifically to reduce the immediate impact on the sector, including SMEs.

We recommend manufacturers factor this proposed increase into their 2027 budget planning.

How manufacturers can respond

The consultation remains open until 25 September 2026. Manufacturers who wish to comment on the proposed changes can do so via the MHRA's official online survey. The agency has explicitly encouraged stakeholders to share the consultation with colleagues and networks who may also be affected.

For small and medium-sized enterprises, it is also worth noting that Proposal 4 includes an expanded support framework offering fee waivers or vouchers, capped at £2 million per year. Details on eligibility and scope should be checked directly against the consultation document, since these will only be finalised once the consultation has closed.

Conclusion

The proposed MHRA fee increases are not yet final, but the direction is clear, and anyone affected should use the time remaining before 25 September to submit a response or, at minimum, start preparing their 2027 budget planning accordingly. MedNet EC-REP can help you assess how these changes affect the registration done by your UK Responsible Person and advise you on all questions relating to your UK market access.