‘Project Glass Box’ - UK Reveals Roadmap For AI Medtech Regulation

The MHRA recently announced plans to review and reform how medical devices with AI or software components are to be regulated in the UK. Its new roadmap sheds light on how, exactly, it will deliver on these ambitions.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) aims to be recognized globally as a “home of responsible innovation” when it comes to regulating software and artificial intelligence (AI) when used as medical devices.

This is according to its new software and AI as a medical device change program, the details of which...