Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system
Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must be reported to the MHRA.
For software as a medical device (SaMD), indirect harm is the most probable outcome of adverse incidents and may occur as a consequence of the medical decision, action taken/not taken by healthcare professionals and/ or patients and the public based on information or result(s) provided by the SaMD.
Examples of indirect harm include:
- delayed diagnosis
- delayed treatment
- inappropriate treatment
- absence of treatment or
- transfusion of inappropriate materials.
Examples of what indirect harm may be caused by:
- imprecise results
- inadequate quality controls
- inadequate calibration
- false positive or
- false negative results.
For self-testing devices, a medical decision may be made by the USER of the device who is also the patient.
This content is available under the Open Government Licence v3.0.