Any professional who uses devices according to MedDO/IvDO and notices a serious incident is obliged by law to notify the supplier and Swissmedic. The following guidance document applies to all professionals. It explains the reasons for the reporting obligation, defines what constitutes a serious incident, and specifies the information required for a complete incident report to Swissmedic.
Swissmedic
New guideline: Swiss Good Practice for Materiovigilance in In-vitro Diagnostics (GPMV-IVD)
Original title: New guideline «Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik» (GPMV-IVD)
Guidance on serious incident reporting obligations for IVD professionals, defining incidents and specifying required information for Swissmedic notification.
Published by Swissmedic. HealthSignal links to the original document; the summary above is extracted from the source text.