Hello Members,
If we have a Software that meets IMDRF Medical Device definition, and we say that we are using a hardware medical device (which has got regulatory approval/clearance) as an accessory to SaMD, does it mean that it now a Medical Device System and not an SaMD? I am clear that this is not the case, but checking if I could be wrong or other regulatory resources I have not considered. I know SaMD cannot be part of a medical device integrated or accessory, but if a Medical Device Software (62304 terminology) is a medical device in its own and used hardware medical device as accessory, do we still see the software as SaMD?
If we have a Software that meets IMDRF Medical Device definition, and we say that we are using a hardware medical device (which has got regulatory approval/clearance) as an accessory to SaMD, does it mean that it now a Medical Device System and not an SaMD? I am clear that this is not the case, but checking if I could be wrong or other regulatory resources I have not considered. I know SaMD cannot be part of a medical device integrated or accessory, but if a Medical Device Software (62304 terminology) is a medical device in its own and used hardware medical device as accessory, do we still see the software as SaMD?
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