The MHRA’s 2024 consultation on statutory fees sought views on proposals to increase regulatory fees and introduce new cost-recovery measures for medical devices. The proposals included increases to existing fees, the introduction of annual registration fees linked to GMDN codes, and a new paid regulatory advice service intended to support medical device manufacturers and suppliers.

The BHTA encouraged members across the medical technology sector to engage with the consultation and share evidence on the likely impact of the proposed changes. Drawing on member feedback and detailed analysis, the Association’s response highlighted concerns around rising regulatory costs, the potential effect on innovation, investment and market access, and the cumulative financial burden facing businesses already operating in a challenging economic environment. The BHTA also emphasised the importance of ensuring that the UK remains an attractive and competitive market for medical technologies while maintaining effective regulatory oversight.

Download the relevant documents:

Click HERE to download the consultation document.

Click HERE to download the BHTA response to this consultation.

This consultation invited feedback on proposed changes to MHRA statutory fees, including a 10% increase, targeted adjustments to address under-recovering fees, and the introduction of new charges for certain services. These proposals were intended to ensure the MHRA can sustainably deliver high-quality, efficient regulatory services. BHTA encouraged members to review the proposals and consider the potential impact on the medical technology sector and associated businesses.

Download the relevant documents:

Click HERE to download the consultation documents.

Click HERE to download the BHTA response to this consultation.