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Regulation and official guidance

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:

  • misdiagnosis
  • 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.

Key Information

Jurisdiction: UK - UK-wide

Name of organisation: MHRA

License: Open Government Licence v3.0


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