From:
Medicines and Healthcare products Regulatory Agency
Published:
21 October 2026
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 today, 21 October 2026, 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 the long-term certainty they need on access to medical devices. By continuing to recognise CE marked devices, we’re ensuring that patients across Great Britain maintain uninterrupted access to the medical technologies they depend on, from life-saving diagnostics to everyday treatments, while our wider device reforms will ensure our regulatory framework is ready for the innovative technologies of tomorrow, including AI-powered medical devices. The MHRA will continue to oversee the safety of every device on the UK market, and we remain committed to working closely with international partners to identify and act on safety concerns quickly.”
Steve Lee, Executive Director, Regulation, ABHI, said:
“Regulatory predictability and avoiding unnecessary duplication are fundamental to industry investment decisions, which ultimately determine how quickly patients can access new technologies. Long-term recognition of CE marking is therefore a significant and welcome decision, providing much-needed certainty for manufacturers, safeguarding patient access and strengthening the UK’s position as an attractive and competitive market for HealthTech.
“We look forward to its implementation, with this practical and proportionate approach supporting continuity of supply and ensuring friction-free access to the medical devices, IVDs and digital health technologies on which UK patients, citizens and the NHS rely.”
The government will continue to engage with patients, clinicians and industry as these arrangements are implemented, including a programme of engagement sessions with patient groups to explain the response and address questions on safety and oversight.
Notes to Editors
The consultation on the future regulation of medical devices sought views on the indefinite recognition of CE marked devices in Great Britain.
The MHRA will continue to oversee all devices on the UK market and has strengthened its post-market surveillance confirms Government indefinite marked recognition
