Guidance for reporting adverse incidents involving software as a medical device

The Medicines & Healthcare Products Regulatory Agency (MHRA) has published a document entitled ‘Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system’.

The document covers what to report, examples of types of adverse incidents that may be reportable, and how they should be reported.

It states that any event meeting this reporting criteria is considered an adverse incident and must be reported to the MHRA. For software as a medical device (SaMD), indirect harm is noted to be “the most probable outcome” of adverse incidents and may occur as a consequence of a medical decision, or action taken or not taken based on information provided by the SaMD.

Examples of indirect harm could include missed diagnosis, delayed diagnosis, inappropriate treatment or transfusion of inappropriate materials, and could be causes by SaMD providing imprecise results, inadequate quality controls, inadequate calibration, and false positive or false negative results.

Examples of the types of adverse incidents that may be reportable include performance issues; diagnostic accuracy issues; decision support software resulting in harm; issues with connected hardware or software; human-device interface problems; use error resulting in harm; inadequate labelling and instructions for use; and computer system security problems.

The document notes some examples, such as a mental health tool fails to alert healthcare professional as per the instructions for use when user’s mental health status reaches a predetermined clinical threshold; remote monitoring of vital signs could lead to delay to diagnosis and treatment if it fails to detect the correct physiological parameters; artificial intelligence diagnostic and triage tools failing to identify clinically relevant brain image findings related to acute stroke leading to an incorrect, delayed or missed diagnosis; and AI tools intended to identify “normal” x-rays misses an abnormality leading to an incorrect, delayed or missed diagnosis.

In terms of how these incidents should be reported, MHRA points to general guidance on vigilance provided here.

The document goes on to provide clarification on how to report as individual events; report as periodic summary reports; report at the time an adverse trend is identified; and report information. It highlights that individual reports should be submitted to its MORE portal, which requires registering with the MHRA.

Read the guidance in full here.