The MHRA has launched a consultation seeking views on proposed changes to its statutory fees as part of full-cost recovery plans in line with HM Treasury “Managing Public Money” guidance. The MHRA last updated its fees in April 2023.

The changes are grouped into five proposals:

Proposal 1 – increase in certain statutory fees to ensure continued cost recovery, based on staff costs (including annual pay rises, which are determined elsewhere in government) and corporate overheads, including maintenance and system investments. An indexation of 8.85% was then also added to all fees. Most fees in this area relate to medicines, but also include those relating to drug-device combination products, clinical investigations for devices and fees for Approved Bodies.

Proposal 2 – amendment of Medical Device Registration fee to include costs for post-market work. This would replace the current funding model which sees post-market work funded by a grant from DHSC. The modified Medical Device Registration Fee will be calculated by relating staff costs for post-market work to the number of Global Medical Device Nomenclature (GMDN) categories registered to each manufacturer. The new registration fee is proposed at £210 per GMDN registration, with the MHRA calculating that 44% of currently registered suppliers would only need to register for one GMDN category.

Under this proposal the MHRA notes one exception to the proposed ‘equitable distribution of MHRA costs across GMDN categories’: custom made dental appliance manufacturers. A single GMDN fee will be charged in these cases, and this has been taken into account in the figure of £210.

Proposal 3 – a new service providing regulatory advice meetings for medical devices to support understanding of the application of UK’s regulatory framework. The MHRA will aim to target this service in particular to those developing novel and/or complex products with the potential to significantly improve patient outcomes, where the application of the Regulations is not straightforward and easily understood. This service would be for complex queries rather than those that might be readily answered by applicants consulting the relevant online guidance. The service is proposed to be charged at £987 for a one hour meeting.

Proposal 4 – amendment of fees for three existing services (scientific advice meetings, control testing and unlicensed medicines importation) and removal or 51 fees no longer in use.

Proposal 5 – changes to update and clarify the legal definition of a “standard variation” application for homeopathic products.

The implementation date of the proposed changes is April 2025, and the consultation will close on 24^th October 2024.

The BDIA will be submitting a response to the consultation, and we would welcome any views from members by 17th October. Please send your input to Adam Stanley on [email protected]