AI Medical Device Software Under the MDR

AI Medical Device Software Under the MDR

By DNV
AI Medical Device Software Under the MDR

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. It also provides a review of requirements to be addressed in order to bring an SaMD to market.

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