The Medicines and Healthcare products Regulatory Agency (MHRA) set out its strategic approach to artificial intelligence (AI) this April just before the UK general election was called and a Labour government was subsequently formed in July. The new administration has earmarked the life sciences industry, including AI in healthcare, as...

Medical device manufacturers placing products on the market in Great Britain face a range of regulatory challenges, including the advent of the new UKCA marking regime (replacing CE marking), the lack of capacity among UK approved bodies to certify applicable medical devices and uncertainty over the future regulation of medical...

Government further delays use of UK product safety marking From 1 January 2023, businesses were being asked to use the UKCA marking instead of the CE mark, but the government has announced this month that this deadline will be extended by two years to offer businesses flexibility. Businesses now have...

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its guidance for manufacturers on what, when and how to report adverse incidents involving software as a medical device (SaMD). This follows the previous roadmap published by the MHRA. (Read our previous Insight for more.) Uses of SaMD in the...