For medical device manufacturers targeting the UK, a major announcement offers greater certainty: the UK government has confirmed its decision to recognize CE-marked medical devices indefinitely in Great Britain, avoiding an additional domestic approval process for qualifying devices.
Announced on October 21, 2026, the decision supports continued access to medical devices and in vitro diagnostic devices (IVDs) already meeting EU requirements. The UKCA marking route will remain available alongside CE recognition.
For manufacturers, this creates an opportunity to plan EU and Great Britain market access with fewer duplicative regulatory activities—and greater confidence about the long-term value of their EU compliance investment.
The government intends to recognize devices complying with the EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR) indefinitely. Recognition means qualifying CE-marked devices can access the Great Britain market without an additional domestic premarket review. However, manufacturers must still meet applicable registration and other domestic requirements.
The practical benefit is significant: manufacturers using the recognized CE route would not need to repeat conformity assessment solely to obtain UKCA marking for Great Britain. This supports more predictable launch planning and continued supply to patients and healthcare providers.
The decision is confirmed; legislative implementation is still ahead
Manufacturers should distinguish the announcement from completed legal implementation. The MHRA plans to introduce the necessary legislative changes, subject to parliamentary approval, before June 30, 2028.
The government also intends to align recognition of eligible legacy EU MDD devices with EU transition timelines. Manufacturers should therefore evaluate their specific device’s regulatory status before changing existing transition plans.
CE recognition does not eliminate the responsibilities associated with supplying devices in Great Britain. Manufacturers must continue to:
These requirements deserve a clear owner, documented procedures, and ongoing attention. A streamlined market access route still requires a well-managed compliance program.
This announcement concerns Great Britain—England, Scotland, and Wales. Northern Ireland operates under a distinct regulatory framework, where CE marking remains required under applicable EU rules. Manufacturers planning UK-wide distribution should account for both frameworks.
RQMIS helps manufacturers turn regulatory developments into practical market access plans. From evaluating CE recognition eligibility and supporting MHRA registration to UK Responsible Person services and post-market compliance, our team can help identify what your organization needs to enter and maintain its position in the market.
Planning to bring your CE-marked device to the UK? Contact RQMIS to develop a clear, coordinated strategy for your next step.