AI medical devices

The UK’s MHRA reported a record surge in medical device testing and approvals in 2025, driven by rapid growth in neurotechnology and AI‑powered innovations. With reduced fees for small companies and faster review times, the Agency is accelerating access to emerging health technologies across the UK.

After years of regulatory complexity, the EU Commission offers medical device manufacturers a path forward: proposed changes limit AI Act requirements for devices, streamline risk classifications, and create efficiencies that could reduce costs and speed innovation.