The state of the art ensures that the device complies with current medical practice. It has more of a focus on indications for use and current medical treatment guidelines. If your device was used for a long time, but newer treatments are now the standard of care as a result of better outcomes or patient preference, it could point to a different risk/benefit analysis on the device. We have had CERs submitted for Notified Body review that incorporate a State of the Art report, so this portion has been practiced by some organizations.
