Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential impact of the Medicines and Healthcare products Regulatory Agency’s proposed annual registration fees for medical devices under the Device Online Registration System on (a) small and (b) micro medical device manufacturers; and what steps he is taking to ensure that those fees do not disproportionately affect family-run and other niche low-volume manufacturers.

The new medical devices registration fee is designed to be proportionate to the breadth of presence of each manufacturer across the medical device market in Great Britain. In response to consultation feedback, the fee has been set at the minimum number of Global Medical Device Nomenclature (GMDN) Level 2 Categories that cover a manufacturer’s registered products. GMDN Level 2 Categories are sufficiently broad to cover the product range of a typical small or micro company. Based on the registration data held in November 2025, 55% of manufacturers will only pay a single fee of £300. The Medicines and Healthcare products Regulatory Agency (MHRA) is currently contacting all manufacturers individually, setting out the number of GMDN Level 2 Categories they would be charged for, based on their registrations in November 2025. This is part of an ongoing MHRA campaign to ask manufacturers to review their registrations before 31 March 2026, to ensure that they have only registered products they manufacture and place on the market. This exercise is likely to increase the number of manufacturers only paying one fee of £300.

The MHRA has strengthened the safety and surveillance system for medical devices following the post-market surveillance legislation, SI 2024 No. 1368, that came into force on 16 June 2025.

In addition to the clear benefits to patient safety, the new legislation and resulting increased post-market surveillance requirements are a critical enabler of the MHRA’s more risk-proportionate, pro-innovation approach to regulation that is heralded in the NHS 10-year plan as the MHRA can be more confident in picking up safety issues in real world data.