Reporting Incidents & FSCAs (Vigilance)

Any professional who becomes aware of a serious incident when using devices must report this to the supplier and the responsible authority.

‘Serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:

• The death of a patient, user or other person,
• the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
• a serious public health threat.

EEA Law: 

The responsible authority for devices placed on the market under EEA law is the Office of Public Health. The following notification form should be used for notification.

Notification Form Incident User (EEA)

Customs Convetion Law:

The responsible authority for devices placed on the market under customs convention law is Swissmedic. For more information and the appropriate notification form, visit the website of Swissmedic.

Due to the parallel marketability (see market-access), either the provisions under EEA law or customs convention law apply with regard to vigilance. Depending on the law under which the device was placed on the market, either EEA law or customs convention law applies accordingly.

EEA Law:

According to Art. 87 and 88 of Regulation (EU) 2017/745 on medical devices (MDR) and Art. 82 and 83 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), manufacturers are responsible for reporting serious incidents, field safety corrective actions (FSCA), and trend reports.

For devices placed on the market under EEA law, report must be made to the Office of Public Health. Until EUDAMED is functional, information is exchanged via email to medical.devices@llv.li. The European-accorded reporting forms are to be used for reporting.

Customs Convention Law:

According to Art. 66 MedDO and Art. 59 IvDO, manufacturers and persons who assemble systems or procedure packs, or their authorized representatives if applicable, are responsible for reporting serious incidents, field safety corrective actions (FSCA), and trend reports.

For devices placed on the market under customs convention law, report must be made to Swissmedic.

Further information on the reporting modalities can be found on the website of Swissmedic.