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EU AI Act's interplay with medical device rules outlined in draft of guidance

By Luca Bertuzzi ( February 26, 2025, 19:12 GMT | Insight) -- An early draft of a document on the interplay between the EU AI Act and medical device regulations discusses questions that are bound to arise on how the AI law’s requirements will interact with product safety rules, notably in terms of post-market monitoring, conformity assessment procedures and real-world testing. An early draft of a document on the interplay between the AI Act and medical device regulations anticipates some of the questions that are bound to arise on how the AI law’s requirements will interact with EU product safety rules....

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