‘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.
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Experts in software and AI medtech regulation from the UK’s MHRA have outlined the questions that device developers should seek to answer when preparing for the regulatory process.
Abbott landed a surprise US FDA approval for the FreeStyle Libre 3 glucose monitoring system. Also this week: updated guidance documents on software (UK) and angioplasty catheters (US), FDA clearances for Candesant and Moximed, new regulatory requirements for spinal spheres, and a warning on Halyard masks.
The UK government has proposed a “pro-innovation” AI regulation strategy, which will utilize the expertise of existing regulators and avoid new legislation. But what does this mean for the medtech sector, and how does the UK approach differ from the EU’s AI Act?