Reporting adverse incidents involving software as a medical device under the vigilance system
Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore reportable.
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This guidance provides information for manufacturers of software as a medical device. It outlines events that may cause indirect harm and are therefore reportable.
You should read this in conjunction with the guidelines on medical devices post-market surveillance which sets out the general adverse incident reporting obligations on all manufacturers of medical devices including software as a medical device.