Swissmedic inspects whether medical devices are safe and effective and whether Swiss market operators are fulfilling their obligations on the basis of suspicion reports from the market and spot checks (focus campaigns). This means:
- Assessing risks: Swissmedic evaluates suspicion reports and decides on a risk-based approach whether further steps are necessary.
- Determining the facts: Swissmedic investigates the actual situation by gathering information from the parties involved, conducting inspections and checking devices.
- Taking measures: If problems are identified, Swissmedic requires those responsible to take corrective action or orders measures (e.g. bans on marketing certain devices).
If Swissmedic takes measures as part of market monitoring of medical devices, this is done in administrative procedures. These procedures are governed by the corresponding federal act (APA; SR 172.021).