Serious incident
Short definition
A serious incident is any incident involving a medical device that directly or indirectly led, might have led or might lead to death, a serious deterioration in a person's state of health or a serious public health threat.
In plain language
The definition is in Article 2, point 65, of Regulation (EU) 2017/745. The manufacturer must report it to the competent authority, in Portugal Infarmed, within 15 days at most, or 10 days in the event of death or an unanticipated serious deterioration, or 2 days in the event of a serious public health threat (Article 87). Healthcare professionals can also report incidents to Infarmed.