BHTA members encouraged to respond to MHRA consultation on statutory fees

Last Updated on 21/08/2026 by Sarah Sarsby

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposals to update the statutory fees it charges for regulatory services from 1 April 2027.

The consultation seeks views on changes intended to enable the MHRA to recover the costs of delivering its regulatory services, while investing in faster, more reliable, and more predictable services.

BHTA members are encouraged to review the proposals and share evidence on how the changes could affect their organisations.

The BHTA will also be responding to this consultation on behalf of its members. Read the BHTA’s responses to previous government consultations here.

Key proposals within the consultation

The MHRA receives around 80 percent of its income from statutory fees, which are charges for regulatory services such as medical device clinical investigations, regulatory advice, and post-market surveillance. Fees are set on a cost-recovery basis, and the MHRA regularly reviews them against the cost of providing its services.

Key proposals include:

• An 8.93 percent increase to 180 statutory fees, representing 62 percent of MHRA statutory fees. This is an indexation increase intended to reflect expected changes in staff pay and employer costs rather than changes to the underlying services.
• Increases of around 27 percent for 25 higher-value services. The MHRA describes these as services where there is demand for more reliable, predictable, and timely delivery, and where providing the service is expected to cost more. The additional income would fund areas including specialist capacity, training, and digital infrastructure.
• Adjustments to 73 existing fees where the MHRA says current charges no longer reflect the cost of delivering the service. A device-related example is the fee for a Device Regulatory Advice meeting, which would increase from £987 to £2,245, a rise of 127 percent.
• Enhanced financial support for eligible small and medium-sized enterprises (SMEs), alongside improvements to scientific advice and enhanced service standards for selected services.

What could the proposals mean for BHTA members?

Of particular relevance to BHTA members involved in medical devices is the annual post-market surveillance (PMS) registration fee. The MHRA proposes increasing this from £300 to £511 per chargeable Global Medical Device Nomenclature (GMDN) Level 2 category, a rise of 70 percent, from 1 April 2027.

The fee funds the MHRA’s strengthened post-market surveillance activities, including reviewing adverse incident reports, field safety corrective actions, and other vigilance data. The MHRA had previously proposed moving to full cost recovery in 2027/28, but is now proposing to retain partial government subsidy during 2027/28 and 2028/29 to reduce the immediate impact on manufacturers, including SMEs.

The consultation also proposes enhanced support for eligible UK-based SMEs developing innovative products. This would operate through a waiver or voucher mechanism covering the full cost of eligible fees, subject to qualifying criteria and an annual scheme cap of £2 million.

Given the range of proposed changes, BHTA members are encouraged to review the MHRA’s full consultation document, including the tables of current and proposed fees in Annex B, to identify the changes relevant to their organisations and consider the potential financial and operational impact. The consultation specifically invites evidence on the impact of fee increases on market activity, innovation, and production, as well as views on the PMS fee, SME support, and individual fee adjustments.

How to respond

Read the MHRA consultation on statutory fees 2026, including the full consultation document and detailed fee tables.

Complete the MHRA online consultation survey.

The consultation closes on 25 September 2026.