# The Medical Devices (Fees Amendment) Regulations 2026, Note: Explanatory note


(This note is not part of the Regulations)
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”).
These Regulations introduce a new annual registration fee structure, where the fee is based on the number of Global Medical Device Nomenclature (“GMDN”) categories which apply to the devices the manufacturer has registered with the Secretary of State. The GMDN system codifies medical devices by categorising them into five levels of increasing granularity. The references to Level 1 and Level 2 Categories are to the first two of these levels. This follows a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 29 August 2024. A summary of the consultation responses and the Government’s response and further response to the consultation are published on the MHRA’s website ( www.gov.uk/government/consultations/mhra-consultation-on-statutory-fees-proposals-on-ongoing-cost-recovery).
Regulations 3 and 4 amend the 2002 Regulations to introduce the new fee structure for devices registered pursuant to the 2002 Regulations. Regulation 5 amends the 2021 Regulations to introduce the new fee structure for custom-made devices registered pursuant to the 2021 Regulations.
A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen. A de minimis impact assessment is available from the Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU.

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Source: https://www.legislation.gov.uk/ukdsi/2026/9780348277739/note (the official version)
Page: https://openlegislation.uk/draft-medical-devices-fees-amendment-regulations-2026/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.