Vigilance Reporting Obligations for Medical Device Manufacturers and Importers in Switzerland

Legal Basis and Scope

Under the Medical Devices Ordinance (MedDO) and aligned with EU MDR vigilance requirements, manufacturers and importers placing medical devices on the Swiss market must operate a systematic post-market surveillance and vigilance system. This includes monitoring device performance, collecting and evaluating incident reports, reporting serious incidents and trends to Swissmedic, initiating and coordinating field safety corrective actions (FSCAs), and maintaining comprehensive records. The obligations apply throughout the device lifecycle to ensure ongoing safety and performance. Hersteller / Inverkehrbringer - Swissmedic

Key Obligations

Manufacturers and importers must:

• Establish internal procedures for incident collection, investigation, and evaluation.
• Report serious incidents and potential serious public health threats to Swissmedic.
• Monitor and report trends indicating increased risk.
• Initiate FSCAs when necessary and issue Field Safety Notices (FSNs) to users.
• Provide periodic summary reports on vigilance activities.
• Cooperate with Swissmedic during investigations and inspections.
• Maintain technical documentation and vigilance records for the required retention period.

Importers have additional duties to forward user reports to the manufacturer and report directly to Swissmedic if the manufacturer is non-responsive.

Reportable Events and Timelines

• Serious incidents – report immediately (2 days for death/life-threatening, 10 days otherwise).
• Incidents with potential serious harm – report within 15 days.
• Trends – report without undue delay upon identification.
• FSCAs – notify Swissmedic before implementation; submit FSNs and implementation status.
• Periodic summary reports – annually or as specified.

Reports are submitted via the Swissmedic e-Business portal using dedicated vigilance forms, including device details (UDI where applicable), event description, root cause analysis, and corrective/preventive actions.

Field Safety Corrective Actions (FSCAs)

When a risk requires action, manufacturers must:

• Assess urgency and scope.
• Develop corrective plan (e.g., recall, field modification, user instructions).
• Notify Swissmedic and provide draft FSN.
• Distribute FSN to all affected users/operators in Switzerland.
• Report implementation progress and completion.

Swissmedic may request modifications to the FSN or additional measures.

Record-Keeping and Cooperation

• Retain all vigilance-related records (reports, investigations, FSCA documentation) for at least 5 years after last device placement or longer per risk class.
• Provide records to Swissmedic upon request.
• Participate in Swissmedic-led investigations or audits.

Non-compliance may result in administrative sanctions, market restrictions, or product withdrawal.

Practical Guidance

Swissmedic publishes detailed vigilance guidance, report templates, FSN examples, timelines, and FAQs. Manufacturers/importers are encouraged to establish direct contact points, subscribe to Swissmedic alerts, and integrate vigilance into quality management systems. Early reporting and transparent communication support effective risk mitigation.

This manufacturer/importer vigilance framework ensures proactive safety monitoring, rapid response to emerging risks, and alignment with international standards while maintaining Swiss regulatory oversight for medical devices. Complete obligations, submission tools, and resources are available on the Swissmedic manufacturer/importer vigilance page. Hersteller / Inverkehrbringer - Swissmedic