Risk assessment and classification of medical device software for the internet of medical things

HIGHLIGHTS

SUMMARY

IMDRF defines SaMD as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device". In recent years, medical device regulations have tried to keep pace with innovations in digital healthcare, recognizing that medical device software and SaMDs fall within their scope as "active medical devices". To what extent does the risk profile of a connected, intelligent medical device - based on its risk classification declared by manufacturers at certification, regulatory review, or market approval - changes once the device is in use? 2 . . .

 



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