Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to (a) ensure that medical device manufacturers can verify the General Medical Device Nomenclature categories and associated charges used to calculate their annual registration fees under the Device Online Registration System and (b) minimise duplicative regulatory and registration costs for UK-based manufacturers arising from divergence between the UK regime and the EU’s EUDAMED system.

When the registration system updates for collecting the new medical device registration fee go live on 1 April 2026, the system will have the functionality to show manufacturers the Global Medical Device Nomenclature (GMDN) Level 2 Categories they are being charged for. In the meantime, the Medicines and Healthcare products Regulatory Agency (MHRA) will make available, to customers who specifically request this, the breakdown of GMDN Level 2 Categories they would be charged for, based on their registrations this November. The MHRA has made it clear to customers that these are estimates only. 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 the products they place on the market. Another round of more accurate fee estimates in late February/early March 2026 is planned.

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.

The MHRA post market surveillance depends on the registration of all medical devices in the United Kingdom. The UK is not involved in the European database on medical devices, or EUDAMED, and the market surveillance mechanisms it supports.