CH-VIGILANCE
Swissmedic vigilance
Reporting of incidents and recalls to Swissmedic
- Category
- Post-market
- Market
- Switzerland
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
MedDO Article 66 adopts the MDR deadlines: 15 days as a general rule, 10 days in the event of death or an unanticipated serious deterioration in health, 2 days in the event of a serious public health threat, counted from the day the manufacturer becomes aware of the incident. Field safety corrective actions are also notified to Swissmedic. The periodic safety update report falls under MedDO Articles 60 to 62, not vigilance.
Official sources
https://www.fedlex.admin.ch/eli/cc/2020/552/frSee where this text lands in your roadmap
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