Any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device

An IVD rarely harms a patient physically, so the IVDR counts indirect harm through wrong results as part of the incident definition. A false result that led to the wrong treatment, or to no treatment, can therefore be a reportable incident.

This should be understood to include any harm to a person’s health, which is not physically and directly caused by an IVD but is a consequence of a medical decision, action taken or not taken, based on incorrect information or results obtained with the IVD.

MDCG 2023-3 Rev.2, Question 8 (Article 2(67) IVDR)