Great Britain to indefinitely accept CE-marked medical devices alongside UKCA route, MHRA confirms
On 21 October 2026, the Medicines and Healthcare products Regulatory Agency confirmed that Great Britain will accept CE-marked medical devices on a long-term basis without requiring an additional domestic approval route. Currently, more than 90% of medical devices registered for use in Great Britain rely on European CE marking. This decision covers products ranging from insulin pumps and replacement joints to surgical equipment and diagnostic tests. The choice follows a public consultation conducted between February and April 2026 that drew over 1,000 responses from healthcare groups, patients, and industry members. By continuing to recognise European Union safety approvals, the UK government aims to prevent supply disruptions and avoid duplicated testing for manufacturers. For patients and the NHS, the decision means continued access to equipment already sold in the European market. The UK domestic pathway, known as the UKCA mark, will continue to run alongside the recognised CE system while safety monitoring relies on existing reporting mechanisms like the Yellow Card scheme.
What was announced
The Medicines and Healthcare products Regulatory Agency (MHRA) announced on 21 October 2026 that Great Britain will recognise CE-marked medical devices indefinitely. This applies to medical devices and in vitro diagnostic devices already approved for the European Union market.
A public consultation on this proposal ran from 16 February 2026 to 10 April 2026. The MHRA received more than 1,000 responses from healthcare organisations, patients, and industry representatives.
Alongside CE recognition, the UKCA marking route remains active as the UK domestic approval pathway. The government is updating UKCA requirements through a pre-market statutory instrument and seeking primary legislation to build a future licensing framework, particularly for software and artificial intelligence medical devices.
What it means
More than 90% of medical devices registered in Great Britain carry a CE mark. Accepting these approvals long-term means manufacturers will not need to complete a separate UK regulatory process for products already passed in the EU.
This decision reduces regulatory work for suppliers, which helps maintain a steady supply of health technologies to the NHS. Covered items include insulin pumps, replacement joints, surgical equipment, and diagnostic tests.
Safety oversight remains under MHRA authority. The agency will monitor safety using its Yellow Card scheme and share data with international regulatory partners.
What the announcement does not tell us
The announcement does not set out specific calendar dates for when primary legislation regarding the future licensing approach will be introduced or passed. It also does not outline the exact details of the updated UKCA requirements that will be established in the pre-market statutory instrument.
Furthermore, the release does not detail how software and artificial intelligence medical devices will be defined under future rules. It mentions an upcoming series of engagement sessions with patient groups, but it does not provide dates or sign-up details for those events.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is gov.uk: Medicines and Healthcare products Regulatory Agency’s own. Always check the original before acting on anything here.
Patients across Great Britain will have continued access to medical devices and in vitro diagnostic devices (IVDs) already approved for the EU market.
Opens www.gov.uk
More from gov.uk: Medicines and Healthcare products Regulatory Agency
- MHRA sets out approach to strengthen patient and public involvement and engagement in medicines and medical device regulation5 November 2026
- MHRA guidance on its assessment of non-clinical data generated outside OECD system4 November 2026
- Clinical trials for medicines: Inclusion and Diversity Plan pilot findings published3 November 2026
This content is for informational purposes only and is not medical advice. It is not intended to diagnose, treat, cure, or prevent any disease. Consult a healthcare professional before starting any supplement, treatment, or program: especially if you are pregnant, nursing, taking medication, or managing a health condition.