Reporting incidents & FSCAs (vigilance)

Incidents

An incident is an event associated with a medical device. Incidents that are classed as serious and have occurred in Switzerland must be reported to Swissmedic.

Swissmedic systematically collects and evaluates these reports.

This reporting system is designed to protect the health of patients and users. In particular, it aims to avoid recurrences of serious incidents attributable to problems that can be traced to the design, manufacture or use of medical devices.

Field Safety corrective Actions (FSCAs)

If problems occur with medical devices, the manufacturer or the person who assembles the systems or procedure packs (system and procedure pack producer (SPPP)) may have to initiate a Field Safety Corrective Action (FSCA). Swissmedic monitors all FSCAs involving medical devices placed on the market in Switzerland.