Incident and Field Safety Corrective Action Reporting Obligations for Medical Device Users and Operators in Switzerland

Legal Basis and Scope

Under the Medical Devices Ordinance (MedDO) and aligned with EU MDR requirements, users and operators of medical devices in Switzerland have specific vigilance obligations. This includes healthcare institutions, professionals, importers, and other economic operators who become aware of incidents or corrective actions. Reporting covers serious incidents, potential serious public health threats, trends suggesting increased risk, and field safety corrective actions (FSCAs) initiated by manufacturers. The goal is rapid identification of risks, mitigation, and protection of patient safety. Users / operators - Swissmedic

Who Must Report

Reporting is mandatory for:

• Healthcare professionals and institutions using or supervising use of devices.
• Importers and distributors placing devices on the Swiss market.
• Other operators who become aware of reportable events during professional activities.

Manufacturers have separate, more comprehensive obligations, but users/operators must report independently when they identify issues.

Reportable Events

Key reportable items include:

• Serious incidents – any malfunction, deterioration in characteristics/performance, inadequacy of information/instructions, or other issue leading to death, serious deterioration in health, or serious public health threat.
• Incidents with potential for serious harm – even if no harm occurred but could have under similar conditions.
• Trends – increase in frequency/severity suggesting higher risk than previously assessed.
• Field Safety Corrective Actions (FSCAs) – manufacturer-initiated actions (e.g., recalls, modifications, additional instructions) communicated via Field Safety Notices (FSNs); users must report receipt and implementation status if requested.

Non-serious incidents should be reported to the manufacturer but are not mandatory to Swissmedic unless part of a trend.

Reporting Timelines and Process

• Serious incidents/public health threats – report immediately (within 2 days for death/life-threatening, 10 days otherwise).
• Trends/FSCAs – report without undue delay upon awareness.
• Submit via Swissmedic e-Business portal (preferred) or dedicated vigilance forms.
• Include device details (UDI if available), event description, patient outcome, root cause if known, and corrective actions taken.
• Swissmedic may request follow-up information or coordinate with the manufacturer.

Obligations After Reporting

• Cooperate with Swissmedic and manufacturer investigations.
• Implement FSCAs promptly (e.g., quarantine, return, modify devices).
• Maintain records of incidents and actions for inspection.
• Provide patient-level follow-up if required (e.g., implant registries).
• Ensure staff training on vigilance procedures.

Failure to report can result in administrative measures or sanctions.

Practical Guidance

Swissmedic provides detailed checklists, examples of reportable vs non-reportable events, guidance on trend identification, and a vigilance contact point. Users are encouraged to report via the portal for faster processing and to subscribe to FSN alerts. Coordination between users, importers, and manufacturers is essential for effective risk management.

This user/operator vigilance framework complements manufacturer obligations, ensuring multi-layered safety monitoring for medical devices in Switzerland. Full requirements, forms, timelines, and support resources are available on the Swissmedic users/operators vigilance page. Users / operators - Swissmedic