AI Medical Device Software under the MDR

The digitalization of healthcare generates a massive amount of data that exceeds the analytical capabilities of individual clinicians. Artificial intelligence (AI) has the potential to automate the analysis of these data, carrying the promise of better and more sustainable healthcare. However, doing this requires AI medical device software to be as safe and performant as any other trustworthy medical device.

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Significant progress has been made in artificial intelligence (AI) over the past few years. However, substantial work still needs to be done to understand the technical and clinical aspects that make AI software systems different from established medical device software and the impact they have on their regulatory conformity assessment in Europe. Without explicit regulatory guidance, some conformity assessment aspects of AI technologies remain unclear.

This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication.

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