MHRA announce pause in their proposal to move to GMDN-based fees structure.
The MHRA have released their response to their October 2024 fees consultation. This proposed a new medical devices registration fee which would have significantly impacted the IVD industry, particularly SMEs, and was strongly opposed by BIVDA. The MHRA has decided to proceed with the wider fees uplift and continue exploring options on the medical devices registration fee.
BIVDA welcome the decision not to impose this fee, which would have disproportionately fallen on SMEs, and will work with the MHRA and partners to ensure options being explored meet the needs of patients, industry, and the MHRA. Our consultation response was robust, and we worked with a number of other government departments to set out the impact the proposed new fees model would have had on their departmental business.
A fuller update will be provided via our regulatory channels. In the meantime, if you have any questions please contact regulatory@bivda.org.uk
