GLOSSARYEU
Serious Incident Report
A manufacturer's report of a serious incident to the competent authorities. The deadline is 15 days after the manufacturer becomes aware of the incident. The deadline shortens to 10 days for a death or an unanticipated serious deterioration in health, and to 2 days for a serious public health threat.
Avoid This Mistake
Two shorter limits apply: 10 days for death or an unanticipated serious deterioration in health, and 2 days for a serious public health threat.