Swissmedic has updated its checklist for materiovigilance inspections in hospitals, covering medical devices and IVDs, quality management, reporting, traceability, FSN/FSCA processes and staff training.

The European Commission has updated the MIR 7.3.1 vigilance reporting forms under the EU MDR and IVDR. Manufacturers should verify accepted versions and updated XSD/XSL files.

Swissmedic updates guidance on medical device incident reporting. Key timelines, obligations, and implications for manufacturers explained.