Protected: Product Liability for Medical Devices: An Overview of the New Law
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The End of Article 82 of the MDR? Why AI and Software Are Now Taking Center Stage
The planned deletion of Article 82 of the MDR could have far-reaching consequences for software and AI in drug trials. The more digital systems evaluate clinical endpoints or generate evidence, the more important the question becomes: is it an investigational device or an investigational product? It is precisely this distinction that could become the central regulatory challenge in the future.