Key takeaways
CE-marked devices remain recognised
CE-marked medical devices can continue to be placed on the GB market.
Greater certainty for the sector
Manufacturers, suppliers and healthcare providers receive long-term regulatory clarity.
Wider reforms continue
The MHRA will continue overseeing safety as broader reforms progress.
In a significant development, the UK Government has confirmed that CE-marked medical devices will continue to be recognised indefinitely in Great Britain, providing greater certainty for manufacturers, suppliers and healthcare providers.
In practical terms, products already approved for the EU market can continue to be placed on the market in Great Britain without the need for a separate UK approval process.
The announcement will support access to medical technologies, reduce regulatory complexity and reinforce the UK's position as an attractive market for innovation. The Medicines and Healthcare products Regulatory Agency (MHRA) will continue to oversee device safety as wider reforms to the UK's medical devices framework progress.
Jamie Foster, Partner, commented: “This announcement provides much welcome certainty to medical device manufacturers. It continues the MHRA’s approach to streamlining regulatory approval processes alongside recent initiatives such as the AI sandbox and National Commission into the Regulation of AI in Healthcare, which we have summarised here.
Taken together, these initiatives help to promote the UK’s place as an attractive destination for AI, medicines and medical device businesses”.
Our Healthtech team will be monitoring developments closely and provide updates as the wider regulatory reforms progress. You can read the government’s full announcement here.
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