Patients across Great Britain will continue to get the medical devices and in vitro diagnostic devices they rely on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment, after the government confirmed on October 21 that it will accept CE marked devices on a long-term basis. The decision follows a public consultation that ran from February 16 to April 10, 2026 and received more than 1,000 responses from patients, healthcare organisations, industry and others.
The substance is the removal of a duplication. The United Kingdom will not require an additional approval route for devices already approved for the European Union market, and the domestic UKCA marking route continues to operate alongside the recognition arrangement. More than 90 percent of medical devices registered for use in Great Britain currently carry a CE mark, so the arrangement covers nearly the whole market. The government said the approach sits within the ambitions of its Life Sciences Sector Plan and 10 Year Health Plan, and reflects the MHRA’s 2030 strategy of expanding reliance routes with trusted regulators.
Safety oversight stays with the MHRA, which the government said will continue to monitor every device on the UK market through mechanisms including the Yellow Card scheme and close work with international partners. Lawrence Tallon, the MHRA chief executive, said the decision gives patients, the NHS and industry the long-term certainty they need, while the wider device reforms leave the framework ready for newer technologies including AI-powered medical devices. A pre-market statutory instrument is separately modernising what devices must meet to be UKCA marked, and the government is seeking enabling powers through primary legislation for a future licensing approach.
Industry welcomed it. Steve Lee of the Association of British HealthTech Industries called long-term recognition a significant and welcome decision, arguing that regulatory predictability and avoiding unnecessary duplication are fundamental to investment decisions and ultimately determine how quickly patients get new technologies. The government said it will keep engaging patients, clinicians and industry as the arrangements are implemented, including sessions with patient groups on safety and oversight.