The MHRA is continuing to publish details on how software and AI medical devices will be regulated in the UK post Brexit, with the aim of making the UK an attractive place to launch such products. The MHRA’s recent updates to its ‘Software and AI as a Medical Device Change Programme’ (the Change Programme) intend to “deliver bold steps to provide a regulatory framework that provides a high degree of protection for patients and public, but also makes sure that the UK is recognised globally as a home of responsible innovation for medical device software looking towards a global market.”
The MHRA has also recently announced it will extend the period during which EU CE marks on medical devices (including for software) will be accepted on the UK market, until July 2024.
We set out an overview of these updates below.
Continue Reading Latest on software and AI devices from the MHRA