Module22 April 20264 min read
Module spotlight: Adverse Event Reporting
When a device may have caused harm, regulators expect a timely, structured report. Adverse event reporting makes vigilance a controlled process, not a panic.
By MoniDoseQMS Team
Vigilance is one of the most time-sensitive duties a manufacturer has. When a device may have contributed to a serious incident, authorities expect a report within defined timeframes. Adverse event reporting gives you a structured, traceable way to capture, assess, and report these events.
What you can do
- Capture adverse events in a structured record
- Assess seriousness and reportability
- Link events to complaints, CAPA, and the affected products
- Maintain a traceable history of every report and its outcome
Why it matters
EU MDR vigilance (Articles 87-92) and FDA reporting rules set strict expectations for incident reporting. A controlled process — connected to complaints and field actions — helps you meet the timelines and prove you did.