Essentials of European Medical Device Regulatory Affairs

Vigilance

Unanticipated If the condition leading to the event was not considered in a risk analysis Harm Physical injury or damage to the health of people or damage to property or the environment

Vigilance

Indirect Harm Some diagnostic devices and all IVDs do not act directly on the individual. HARM may occur as a consequence of the medical decision, action taken/not taken on the basis of information or result(s) provided by the device. Examples include:- – misdiagnosis, – delayed diagnosis, – delayed treatment, – inappropriate treatment, – transfusion of inappropriate materials For self-testing devices, a medical decision may be made by the USER of the device who is also the patient