Any professional who uses devices according to MedDO/IvDO 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 notification form.
Responsibility for deciding whether an incident is serious and therefore subject to the reporting obligation 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:
MU680_20_015d_FO Anwendermeldung (PDF, 1 MB, 01.11.2023)Document only available in German, French or Italien
Please note that Swissmedic will only accept user notifications that have been completed in full and are submitted using the form above.
Hospitals are legally obliged to set up a reporting system. As part of this obligation, they must designate a suitable person to assume responsibility for reporting serious incidents involving devices according to MedDO/IvDO 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. The vigilance contact person can be responsible for medical devices according to the Medical Devices Ordinance of 1 July 2020 (MedDO; SR 812.213) or according to the Ordinance of 4 May 2022 on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), or for medical devices according to both ordinances. Please complete the following notification form and send it to materiovigilance@swissmedic.ch
MU680_10_014d_FO Vigilance-Kontaktperson für Medizinprodukte - Mutation (PDF, 1 MB, 30.11.2022)Document only available in German, French or Italian
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, 20.06.2024)(Notification of serious incidents in connection with medical devices and safety notices) Document only available in German, French or Italian
Serious incidents involving medical devices: find out in the video why every report counts!
