Step 2: Determine your reporting deadline | Responding to a medical device safety incident | Guvnor

Step 2 of 5

Classify the incident severity to determine your reporting deadline:

2 calendar days — serious public health threat
10 calendar days — death or unanticipated serious deterioration in health
15 calendar days — all other serious incidents (including anticipated serious deterioration)

Timelines run from when you (the manufacturer or UK Responsible Person) become aware of the incident.