Users and operators


Incidents


Any professional who uses medical devices in the course of their profession and notices a serious incident is obliged by law to notify the supplier and Swissmedic.

This guidance document explains why this notification requirement exists, what is meant by “serious incident” and where to find the information to be forwarded to Swissmedic by means of the user report form:

Responsibility for deciding whether an incident is serious and therefore subject to the notification requirement lies with the user. If the incident is serious, Swissmedic must be notified (materiovigilance@swissmedic.ch) using the following form, which must be submitted electronically and in machine readable format: 

Please note that Swissmedic will only accept user notifications that have been completed in full and are submitted using the form above.

 


Medical devices vigilance in hospitals


Hospitals are legally obliged to set up a reporting system. As part of this obligation, they must designate someone to be responsible for serious incidents involving medical devices and officially notify this vigilance contact person for medical devices to Swissmedic.

Further information can be found in the following guidance document:

Swissmedic must be notified of new vigilance contact persons for medical devices or if the contact details of existing registered contact persons change. This should be done by completing the following form and sending it to materiovigilance@swissmedic.ch

Swissmedic inspects hospitals’ reporting systems. The following document provides a checklist covering the key points.

IN615_10_004d_CL Checkliste für die Inspektion von Systemen der Vigilance betreffend Medizinprodukten (PDF, 1 MB, 26.05.2021)(Meldung schwerwiegender Vorkommnisse im Zusammenhang mit Medizinprodukten und Sicherheitsmitteilungen)
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