Swissmedic Issues Minor Update to Guidance on User Incident Reporting

Swissmedic has published version 3.4 of its Guidance Document: Incident Report User, effective 1 April 2026.

The document provides practical guidance for healthcare professionals on how to report serious incidents involving medical devices and in vitro diagnostics (IVDs) in Switzerland and Liechtenstein.

According to the change history, this update introduces clarifications and editorial adjustments, rather than significant changes to the regulatory framework.

Key elements of the guidance

• User reporting obligations
  Healthcare professionals who become aware of a serious incident must report it to Swissmedic and the supplier/manufacturer.

• Definition of a serious incident
  An incident is considered serious if it led, or could lead, to:

  • Death

  • Serious deterioration in health

  • A serious public health threat

• Reporting timelines

  • 2 days → serious public health threat

  • 10 days → death or serious deterioration

  • 15 days → all other serious incidents

• Information required for reporting
  Reports should include key identifiers such as:

  • Device trade name

  • Manufacturer details

  • Lot/serial number

  • UDI (where available)

  • Clear description of the incident and outcomes

• Device availability for investigation
  Users are instructed not to dispose of affected devices, enabling proper investigation by the manufacturer.

• Role of Swissmedic
  Swissmedic assesses reports, monitors trends, and oversees investigations, while manufacturers remain responsible for analysing devices and implementing corrective actions.

Context within the regulatory framework

The guidance is aligned with:

• Swiss MedDO and IvDO

• Concepts and definitions under EU MDR (2017/745) and IVDR (2017/746)

It also references national guidance such as GPMV-Spital, with GPMV-IVD expected to be published in 2026.

What manufacturers should consider

Although this guidance is addressed to users, it has practical implications for manufacturers, particularly in vigilance and post-market surveillance:

• Ensure efficient complaint handling and vigilance systems
  Users are legally required to report incidents to manufacturers, reinforcing the need for clear intake and investigation processes.

• Be prepared for timely investigations
  Reporting timelines for users may accelerate manufacturer awareness of incidents, requiring responsive internal procedures.

• Maintain robust traceability systems
  The emphasis on identifiers, including UDI, highlights the importance of accurate device traceability.

• Support users in reporting
  Clear instructions for use and accessible product information can facilitate accurate and complete incident reports.

Final note

This update does not introduce new obligations but reinforces the operational aspects of incident reporting within the Swiss vigilance system. For manufacturers, it is a useful reminder to ensure that post-market surveillance and vigilance processes remain aligned and effective.

Read the full document below.