Dear members, The Medical Devices (Fees Amendment) Regulations 2026 was laid before parliament on the 16th December, and is now subject to parliamentary process. The draft legislation confirms the move to the annual fee, which is initially set to be £300.00, and it confirms the adoption of GMDN level 2 or level 1 (where there is no relevant level 2 term) terms as the basis for the billing model.
These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”) and the Medical Devices (Northern Ireland Protocol) Regulations 2021 (“the 2021 Regulations”).
