Published 29 October 2026
The government and the Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed that medical devices carrying an EU CE mark will continue to be accepted on the Great Britain market on a long-term basis. The decision, announced on 21 October 2026, is relevant to anyone who buys or supplies mobility equipment, because many products sold in the UK carry a CE mark.
What was announced
According to the official GOV.UK announcement, the UK will not require an additional approval route for CE-marked medical devices and in vitro diagnostic devices, which avoids duplicate approvals for manufacturers. More than 90% of medical devices registered for use in Great Britain currently carry a CE mark. The decision follows a public consultation that ran from 16 February to 10 April 2026 and received more than 1,000 responses from patients, healthcare organisations, industry and others.
MHRA Chief Executive Lawrence Tallon said the decision gives patients, the NHS and industry the long-term certainty they need on access to medical devices.
What stays the same
The UKCA route remains the domestic approval pathway for Great Britain, and a pre-market statutory instrument will update its requirements. The MHRA will continue to oversee all devices on the UK market, including through the Yellow Card scheme and international safety information sharing. The government also plans to seek primary legislation for a future licensing approach covering software and AI devices.
Industry reaction
In a comment piece for THIIS Magazine, Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, called the move hugely significant and said it removes the burden of trying to achieve approval through two separate regimes. She argued a more stable environment helps innovation and investment, and a steadier flow of devices to patients.
Why it matters for mobility buyers
For buyers of wheelchairs, mobility scooters, bathroom mobility products and daily living aids, the practical effect is continuity. Manufacturers that already hold CE certification do not face a second approval just to keep selling in Great Britain, which should help protect supply and range choice. It does not change your own rights: you should still buy from a reputable supplier, check that a product is marked appropriately, and report faults or safety concerns.
Not every mobility product is a regulated medical device, and requirements vary by product type, so always check with the manufacturer or supplier if you are unsure. If you want help finding a reputable supplier, use our company directory to compare reviews.
This is a regulatory announcement rather than a change to anything you must do as a consumer, but it is a useful sign of stability for a sector that relies on international supply chains. We will report further changes to medical device rules as they emerge.
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Published 29 October 2026