Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation

What is it about?

The European Commission has recently published a proposal for a regulation on the use and marketing of artificial intelligence (AI) systems. By laying down safety and transparency requirements for AI, the proposal, if accepted, would also change the requirements for the marketing of AI-based medical devices. This article outlines the main consequences that the adoption of this legislative proposal would have on the regulation of AI-based medical devices.

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