Guidance
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.
Documents
Details
This guidance provides information for manufacturers of Software as a Medical Device. It outlines events that may cause indirect harm and are therefore reportable.
It should be read in conjunction with the guidelines on a medical devices vigilance system MEDDEV 2.12/1 rev 8 which sets out the general adverse incident reporting obligations on all manufacturers of medical devices including software as a medical device.