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UK Government confirms indefinite recognition of CE marked medical devices

Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and a Trustee of the Bios Centre for bioethics reports on the UK Government decision to recognise CE marked medical devices. Patients across Great Britain will continue to ha

UK Government confirms indefinite recognition of CE marked medical devices
Published: | 1 min read
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and a Trustee of the Bios Centre for bioethics reports on the UK Government decision to recognise CE marked medical devices.

Patients across Great Britain will continue to have access to the medical devices and in vitro diagnostic devices (IVDs) they rely on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment, after the government has confirmed it will continue to accept CE marked medical devices on a long-term basis.

The decision follows a public consultation, which ran from 16 February 2026 to 10 April 2026, that received more than 1,000 responses from patients, healthcare organisations, industry and others.

The widely-anticipated decision means the UK will not require an additional approval route for devices already approved for the EU market, avoiding duplication for manufacturers and helping to maintain stable supply and patient access to medical technologies. More than 90% of medical devices registered for use in Great Britain currently carry a CE mark, meaning they have been assessed and approved for the European market, and this approval has been recognised to provide access to the Great British market. Continuing to recognise these devices will help maintain safe, uninterrupted access to the treatments and technologies that patients and the NHS rely on. This sits alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices placed on the market in Great Britain.

Guidance on placing UKCA or CE marked products on the market in Great Britain can be found here.

The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.

About the author

Chris Whitehouse

Political consultant and expert on medtech policy and regulation at Whitehouse Communications, advisor to medtech suppliers, chair of the Urology Trade Association.

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