Much has been written about the EU AI Act, which has now been published in the Official Journal as Regulation (EU) 2024/1689 and entered into force on 1 August 2024.
The AI Act is so-called "horizontal legislation", meaning it applies across industries, and its impact will be felt from agriculture to aerospace and beyond. We are pleased to contribute an expert chapter in The International Comparative Legal Guide on the application of the AI Act to the life sciences industries, with a particular focus on the regulatory framework for so-called "High Risk AI Systems", given the significant impact this will have on AI medical devices.
We discuss what is an AI system, when the AI Act will apply, and focus on when medical devices will be regulated as High Risk AI Systems and the associated obligations on the "provider" who is placing the AI system on the market,as well as "deployers" who use AI systems in a professional capacity. There are also some interesting questions on when pre-marketing testing can be conducted, and of course the overlap between the medical devices and new AI regimes. Finally, we set out some points that life sciencescompanies should consider as they prepare for the implementation of the AI Act. Do let us know if you would like to discuss further!
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