The growing use of AI in medical devices is already leading to improvements in patient outcomes on a mass scale, as well as fundamental changes in the way that healthcare is delivered in the 21st century. However, with all the promise that they offer, these powerful new technologies also demand correspondingly bold shifts in thinking by policy makers. As a result, the EU regulatory landscape is evolving to provide regulators with the powers required to keep pace with ever-increasing rates of innovation and disruption brought about by the use of tools such as predictive algorithms and machine learning in medical devices. We provide an overview of recent developments in this space and highlight some of the crucial issues that manufacturers should be aware of.
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