Published 8 June 2026 · Last updated 22 June 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has published the draft Medical Devices (Amendment) Regulations 2026, marking the most significant reform of the UK’s medical device framework since Brexit. The proposed regulations aim to modernise pre-market requirements while improving patient safety and access to innovative technologies.
The draft regulations, published on 8 May 2026, introduce several key changes that will affect manufacturers and suppliers of mobility aids and assistive devices. These include updated device classification rules, stricter technical documentation requirements, mandatory Unique Device Identification (UDI), and tighter rules around marketing claims.
One notable addition is an International Reliance route, which will allow devices already approved by regulators in the US, Canada, and Australia to access the UK market more quickly. This could benefit consumers by bringing innovative wheelchairs, mobility scooters, and other assistive devices to UK buyers faster.
The British Healthcare Trades Association (BHTA) has been closely monitoring the proposals and advising its members on the implications. Speaking at the BHTA Retailers’ Day in April, industry experts noted that the new regulations would require mobility equipment suppliers to review their compliance processes, particularly around product documentation and post-market surveillance.
For consumers, the changes should ultimately mean better-regulated products with clearer safety standards. The MHRA has emphasised that the reforms are designed to be “patient-centred and proportionate,” balancing safety requirements with the need to maintain access to essential mobility equipment.
The consultation on the draft regulations is open until 19 June 2026, with the final version expected to be adopted in December 2026 and come into force in June 2027. Manufacturers and suppliers of stairlifts, walking aids, and other mobility devices are encouraged to review the proposals and submit feedback.
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Published 8 June 2026 · Last updated 22 June 2026