Essentials of European Medical Device Regulatory Affairs

Vigilance Event

Any information which the manufacturer becomes aware of which relates to the adverse performance of product which is already in the market, for example: – Malfunction or deterioration – False positive or false negative test results – Unanticipated adverse reaction or unanticipated side effect – Unanticipated or unexpected interactions with other substances or products – Unanticipated or unexpected degradation or destruction of the device – Inappropriate therapy – Inaccuracy in the labelling, instructions for use, and/or promotional materials – Inaccuracies in the information supplied with the device Often in the form of a customer complaint but potentially from other sources, such as the manufacturers PMS systems, product design testing, regulatory authorities and more.

Vigilance

Incident Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly , might lead to or might have led to the death of a patient, or USER or of other persons or to a serious deterioration in their state of health Abnormal Use Act or omission of an act by the OPERATOR or USER of a MEDICAL DEVICE as a result of conduct which is beyond any means of risk control by the MANUFACTURER Use Error Act or omission of an act that has a different result to that intended by the MANUFACTURER or expected by the OPERATOR