On May 5th 2025 the European Commission published a new version (7.3.1) of the form for reporting serious incidents (link). This can now be used for submitting reports to Swissmedic, provided that the form is completed in accordance with the CH guide for Switzerland-specific content.
In accordance with the EU publication, this form will also be mandatory for incidents in Switzerland as of November 2025.
Swissmedic provides the new form and the CH guide on its website: www.swissmedic.ch/md-materiovigilance-manufacturers (Incidents section).