More than 9 in 10 devices used in Britain carry an EU mark. They can now stay for good
What happened
On 21 October 2026 the government confirmed that Great Britain will carry on accepting medical devices approved for the European Union market, with no end date. Most medical devices sold in Europe carry a ‘CE’ mark, which shows the device has been through the EU’s approval process. After Brexit, Great Britain kept accepting CE-marked devices, but only for a limited time. Deadlines in June 2028 and June 2030 were going to end that. Manufacturers faced a choice: put their device through a second, British approval process, or stop selling here. That cliff edge has now gone. The Medicines and Healthcare products Regulatory Agency (MHRA) says devices already approved for the EU market will not need an extra British approval route. The decision covers both medical devices and in vitro diagnostic devices, which are the tests run on samples such as blood or urine. The scale is the point. The MHRA says more than 90% of medical devices registered for use in Great Britain carry a CE mark. The examples it gives are not obscure: insulin pumps, replacement joints, diagnostic tests and surgical equipment. Lawrence Tallon, the MHRA’s chief executive, said the decision ‘gives patients, the NHS and industry the long-term certainty they need on access to medical devices’. Steve Lee of the Association of British HealthTech Industries called it ‘a significant and welcome decision’ that gives manufacturers much-needed certainty. The decision follows a public consultation that ran from 16 February to 10 April 2026 and drew more than 1,000 responses from patients, healthcare organisations, industry and others. Three other things were confirmed alongside it. The UKCA mark stays as Great Britain’s own approval route, and new legislation will update what it requires. The government will seek primary legislation to allow a future licensing approach for devices, including software and artificial intelligence. And monitoring of devices already in use carries on, including through the Yellow Card scheme, where patients and staff report problems.
Why this matters
This is a dry announcement about paperwork that could have turned into a very practical problem. Great Britain is a small market by global standards. If a company making a particular insulin pump or blood test had to pay for a second approval just to keep selling here, some would have done the sums and walked away. Not out of malice. Just arithmetic. When a device quietly leaves the market, patients feel it as a supply gap. That is not theoretical. Earlier this month the MHRA issued device safety information about ketone test strips used to spot diabetic ketoacidosis, a dangerous complication of diabetes, with new stock expected to take around four weeks. Anyone who has waited for test strips, pump sets or a replacement part knows how quickly a shortage stops being an administrative matter. Removing a 2028 deadline also changes what hospitals and companies can plan. Trusts can buy equipment with a long working life and expect the supply to continue. Manufacturers can invest in a UK presence. The MHRA has said that long-term certainty on CE recognition was the single biggest request the medical technology industry made of it, and this is that.
What the evidence actually says
A few things are worth separating out, because ‘we will accept EU approvals’ can be read as something it is not. This is a decision about market access, not about lowering safety standards. A CE-marked device still has to meet the EU’s requirements, and once it is in use here the MHRA still monitors it, investigates problems, and can issue alerts and recalls. Nothing in this announcement changes that. It is also not the end of British regulation of devices. The UKCA mark remains as the domestic route. The MHRA has said a smaller number of higher-risk devices, ones that would sit in a higher risk class under Great Britain’s rules than under the EU’s, would go through an international reliance route rather than straight recognition. Parts of this still need Parliament. The pre-market changes come through a statutory instrument, and the future licensing approach needs primary legislation. The announcement does not give a date when everything takes effect. The 90% figure deserves a careful read. It describes the share of devices registered for use in Great Britain that carry a CE mark. That is a count of products, not of how often each one is used, so it measures breadth rather than volume. And the outcome was not a foregone conclusion. As recently as early October, trade reporting suggested indefinite recognition might not make it into the MHRA’s forthcoming pre-market legislation. This announcement settles it.
Qurexa perspective
Our side of healthcare is the unglamorous one: getting the right medicine or supply to the right person’s door, on time. Approval rules feel distant from that, right up until a product stops being available in Britain. Then they are the whole story. The devices in this announcement include the ones people manage their own health with at home: pumps, monitors, test strips. Those usually come with consumables that run out on a schedule. Our medication adherence work is largely about that rhythm, noticing that something is due before it runs out rather than after. Certainty about approvals does not fix supply problems on its own. Manufacturing faults, recalls and global shortages will all still happen. But it removes one avoidable reason for a product to disappear from British shelves, and that is genuinely good news for anyone who depends on a device.
Practical advice
For almost everyone, the honest answer is that there is nothing to do. Your device is not being recalled or withdrawn. Nothing here changes a device you already use or a prescription you already have. Keep using it exactly as you were told to. If you want to know what the marks mean: a CE mark shows EU approval, and a UKCA mark shows Great Britain’s own approval. Either is valid here. Seeing a CE mark on your pump or test kit is not a sign that something is out of date. Keep reporting problems. If a device hurts you, fails, gives a result you do not trust, or arrives with wrong packaging or instructions, report it to the MHRA through the Yellow Card scheme. You do not need to be a health professional, and you do not need to be certain the device was at fault. Those reports are how device alerts begin. Build in a small buffer on consumables. If you depend on test strips, pump sets, catheters or similar, reorder when you have a week or so left rather than on your last one. It costs nothing and absorbs most short delays. Check the leaflet when a batch looks different. Suppliers change and devices get updated. If the packaging, colour or feel of something is not what you expect, read the instructions before using it, and ask your pharmacy if you are unsure. If something you rely on does become hard to get, tell your prescriber early rather than rationing it. There is usually an alternative, but finding one takes a few days.
What to know
Great Britain will keep accepting EU-approved CE-marked medical devices and diagnostic tests with no end date, removing deadlines that had been set for June 2028 and June 2030. More than 90% of devices registered for use here carry that mark, including insulin pumps, replacement joints and diagnostic tests. The MHRA says the decision gives patients, the NHS and manufacturers long-term certainty. Safety monitoring is unchanged. The UKCA mark stays as Great Britain’s own route, some higher-risk devices will go through an international reliance route, and parts of the plan still need Parliament. For patients, nothing changes today: keep using your device as prescribed, keep a small buffer of consumables, and report any problem through the Yellow Card scheme. Sources: Medicines and Healthcare products Regulatory Agency, ‘Government confirms indefinite recognition of CE marked medical devices’, GOV.UK, 21 October 2026, https://www.gov.uk/government/news/government-confirms-indefinite-recognition-of-ce-marked-medical-devices; ‘MHRA consults on indefinite recognition of CE-marked MedTech’, Digital Health, February 2026, https://www.digitalhealth.net/2026/02/mhra-launches-consultation-on-ce-marked-medtech/; ‘Consultation on CE-marked medical devices “could mark major boost to both patients and MedTech growth aims”’, Med-Tech Insights, 11 March 2026, https://med-techinsights.com/2026/03/11/consultation-on-ce-marked-medical-devices-could-mark-major-boost-to-both-patients-and-medtech-growth-aims/ This article is for general information and does not replace advice from a doctor, pharmacist, nurse or other qualified healthcare professional. Never change how you use a prescribed device or medicine without speaking to them first.
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