Market Surveillance Overview
Overview
Market surveillance is Swissmedic's systematic monitoring of devices already on the Swiss market to ensure ongoing MedDO/IVDO compliance. It is Swissmedic's primary post-market regulatory function alongside vigilance management.
Swissmedic's Surveillance Activities
Reactive surveillance — Investigating complaints received from healthcare professionals, patients, and consumers about device performance or safety.
Proactive surveillance — Targeted inspection programmes focusing on specific device types, identified risk signals, or market trends. Swissmedic publishes annual market surveillance plans.
Post-market testing — Purchasing and laboratory testing of devices from the Swiss market to verify labelling claims, performance, and safety.
Document reviews — Requesting and reviewing technical documentation, DoCs, NB certificates, labelling, and complaint records from manufacturers or CH REPs.
Complaint Handling
Complaints about medical devices can be submitted directly to Swissmedic via its website. Each complaint is assessed for regulatory significance. Possible outcomes: information request to manufacturer/CH REP; inspection; FSCA order; safety communication; formal enforcement action.
European Cooperation
Swissmedic participates in European market surveillance coordination through bilateral arrangements with the European Commission and EU competent authorities. Information about non-compliant devices and FSCAs is shared between Swissmedic and EU counterparts.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.