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 — one of the central proposals could involve the annual post-market surveillance fee. Anyone who wants to have a say has only until 25 September 2026 to respond.

What the MHRA consultation proposes

The MHRA is funded entirely through fees and regularly reviews them against the actual cost of delivering its services. 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 — in some cases considerably higher — increases 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.

A significant rise expected for the post-market surveillance fee

One point is particularly relevant for manufacturers registering their devices through a UK Responsible Person: 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). According to early trade-press reporting, the fee could rise noticeably from 1 April 2027 — reliable, officially confirmed figures are not yet available.

We recommend that manufacturers check the exact scale of the proposed increase in the MHRA's official consultation document before finalising their 2027 budget planning. Increases are also being discussed for other device-related services under the consultation, including individual regulatory advice meetings with the agency.

How manufacturers can respond

The consultation remains open until 25 September 2026. Manufacturers and their representatives 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 the proposal includes an expanded support framework offering fee waivers or vouchers. 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.

As your UK Responsible Person, MedNet EC-REP can help you assess how these changes affect your specific registration and advise you on all questions relating to your UK market access.