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, the CH REP must submit reports to Swissmedic within the required timeframes. The CH REP must establish and maintain documented procedures for receiving incident information from the manufacturer, assessing reportability, and submitting reports to Swissmedic. The CH REP is jointly and severally liable for compliance with vigilance reporting obligations.