Deals & regulation
UK will indefinitely recognize CE-marked medical devices in Great Britain
The UK government will continue recognizing CE-marked medical devices and in vitro diagnostic devices in Great Britain indefinitely, avoiding a separate approval route for products already assessed for the EU market. The policy covers devices such as insulin pumps, replacement joints and diagnostic tests; more than 90% of devices currently registered in Great Britain carry the CE mark. The domestic UKCA route remains available, while the MHRA says post-market surveillance and future reforms will address emerging technologies including software and AI devices.
Editorial summary · Publisher article
What matters
- The decision follows a consultation that received more than 1,000 responses.
- CE recognition is intended to reduce duplicated approvals and support continuity of supply for patients and the NHS.
- UKCA remains the domestic approval route and is being modernized through a statutory instrument.
- The MHRA says it will continue safety monitoring, including through the Yellow Card scheme.
Context & caveats
- This is a first-party government announcement; the supplied material does not include independent patient, clinician or manufacturer assessments beyond an industry association’s quoted support.
Why this made the edition
A substantive regulatory decision with clear implications for device supply, NHS access and future AI-medical-device oversight, although the source is a government announcement presenting its own policy.
Source material