CE-marked medical devices will be recognised in Great Britain indefinitely

Medical devices that carry the European CE mark will continue to be accepted in Great Britain with no end date, the government confirmed on 21 October. The announcement was published by the Medicines and Healthcare products Regulatory Agency, which regulates medicines and medical devices in the UK.

The recognition covers general medical devices and in vitro diagnostic devices. The announcement gave insulin pumps, replacement joints, diagnostic tests and surgical equipment as examples of the products involved.

Why it matters

More than 90% of the medical devices registered for use in Great Britain carry a CE mark, according to the announcement. The mark shows that a device has been assessed and approved for the European market.

The decision means the UK will not require an additional approval route for devices already approved for the EU market. The government said this avoids duplication for manufacturers and helps maintain stable supply and patient access to medical technologies.

How the decision was reached

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

The announcement linked the decision to the MHRA's 2030 Strategy, the Life Sciences Sector Plan and the 10 Year Health Plan. The government said it will hold engagement sessions with patient groups to explain the decision and answer questions on safety and oversight.

UKCA stays in place

The UK Conformity Assessed mark, known as UKCA, remains the domestic route for placing devices on the Great Britain market. It is being modernised through a separate pre-market statutory instrument, which sets the rules a device must meet before it is sold.

The government also intends to seek enabling powers through primary legislation for a future licensing approach for medical devices. That approach is meant to respond to advancing technologies, including software and devices that use artificial intelligence. It reflects recommendations from the National Commission into the Regulation of AI in Healthcare.

Safety checks after sale

Recognition of the CE mark does not change the checks that apply once a device is in use. The arrangements sit alongside post-market surveillance and reporting requirements already in place. The MHRA will continue to oversee all devices on the UK market and to monitor safety, including through the Yellow Card scheme, through which patients and health professionals can report a problem with a device.

The MHRA also said it would work closely with international partners to share safety information, so that it can act to protect patients where needed.

Where it applies

The decision covers devices placed on the market in Great Britain, which is England, Scotland and Wales. It sits alongside the UKCA route, which continues to operate as the domestic approval pathway.