PAGB has welcomed the MHRA announcement confirming the indefinite recognition of CE marked medical devices and in vitro diagnostic devices (IVDs) in Great Britain.
The decision follows a public consultation earlier this year, to which PAGB submitted a response, and the devices range from insulin pumps and replacement joints to diagnostic tests and surgical equipment.
The announcement provides greater regulatory certainty for manufacturers placing CE marked devices on the UK market and avoids the need for an additional approval route for products already approved for the European market.
This will help to maintain stable supply and patient access to medical technologies.
This recognition sits alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices placed on the market in Great Britain.
PAGB CEO Michelle Riddalls said: “We welcome the MHRA’s decision to continue recognising CE marked medical devices and IVDs in Great Britain. This is a positive outcome that provides long-term certainty for manufacturers while helping to maintain access to important healthcare products and technologies for consumers.
“This decision will help support continuity of supply, reduce additional administrative burden and give businesses greater confidence when bringing products to the UK market.
“We are particularly pleased to see the Government take forward a number of the approaches supported by PAGB and other industry bodies during the consultation, including the long-term recognition of CE marked devices and the decision not to introduce additional regulatory routes that could have created unnecessary duplication and complexity.”
The consumer healthcare association also welcomed the collaborative approach taken by the MHRA throughout the consultation, which ran from 16 February 2026 to 10 April 2026.
Over 90 per cent of medical devices currently registered for use in Great Britain carry a CE mark, demonstrating compliance with European regulatory requirements. Continued recognition of CE marked devices will help ensure consumers, healthcare professionals and the NHS maintain access to a wide range of established healthcare technologies and products.
For the MHRA, the continued recognition of CE-marked devices also reflects its wider ambition of the MHRA’s 2030 Strategy to expand reliance and recognition routes with trusted regulators, reducing regulatory burden, strengthen supply resilience and supporting timely patient access.
MHRA Chief Executive Lawrence Tallon said: “This decision gives patients, the NHS and industry the long-term certainty they need on access to medical devices.
"By continuing to recognise CE marked devices, we’re ensuring that patients across Great Britain maintain uninterrupted access to the medical technologies they depend on, from life-saving diagnostics to everyday treatments, while our wider device reforms will ensure our regulatory framework is ready for the innovative technologies of tomorrow, including AI-powered medical devices.
"The MHRA will continue to oversee the safety of every device on the UK market, and we remain committed to working closely with international partners to identify and act on safety concerns quickly.”
