How to Report to Swissmedic
The eVigilance Portal
Serious incidents and FSCAs are reported to Swissmedic via the eVigilance portal on the Swissmedic website. The manufacturer or CH REP must have a registered account. Reports can be submitted in German, French, Italian, or English.
Reporting Timeframes
| Incident Type | Timeframe |
|---|---|
| Serious public health threat | 2 calendar days after becoming aware |
| Death or unanticipated serious deterioration | 10 calendar days after becoming aware |
| Other serious incident | 15 calendar days after becoming aware |
| Trend report | 30 calendar days after threshold reached |
| FSCA | Before or simultaneously with implementation |
| Follow-up / final report | As agreed with Swissmedic or within 30 days of event closure |
What a Vigilance Report Must Contain
Initial (preliminary) reports can be brief where full information is not yet available. They must include at minimum: device identification; incident description; timeframe; preliminary assessment. Full information is provided in follow-up/final reports.
CH REP Reporting Obligations
Where the CH REP has been delegated vigilance reporting duties (or where the manufacturer has not reported directly), the CH REP must submit reports to Swissmedic. The CH REP should have documented processes for receiving incident information from the manufacturer and submitting reports within the required timeframes.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.