Reporting incidents & FSCAs (vigilance)


An incident is an event associated with a device according to MedDO/IvDO. Incidents that are classed as serious and have occurred in Switzerland or Liechtenstein 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 devices according to MedDO/IvDO.

Field Safety corrective Actions (FSCAs)

If problems occur with devices according to MedDO/IvDO, 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 devices according to MedDO/IvDO placed on the market in Switzerland or Liechtenstein.