Report incidents & FSCA (Vigilance)
Serious incidents
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;
Field safety corrective action (FSCA)
Field safety corrective action (FSCA) means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
Any professional who becomes aware of a serious incident when using medical devices and IVD must report this to the supplier and the competent authority.
Customs-Treaty-Law:
The competent authority for devices placed on the market under Customs-Treaty-Law is Swissmedic. Further information and the corresponding notification form can be found on the website of Swissmedic.
EEA-Law:
The competent authority for devices placed on the market under EEA-Law is the Office of Public Health. The following notification form must be used for the notification.
Hospitals (*) must set up an internal reporting system within the framework of an established quality management system for the purpose of reporting serious incidents (see upper section “user”). Records and all documents created under the vigilance quality management system must be retained for at least 15 years..
In addition, hospitals must designate a suitable competent person (vigilance contact person) with a medical or technical qualification to assume responsibility for reporting serious incidents. This person must be reported to the competent authority.
(*) Hospitals are health institutions in which inpatient treatment of illnesses or inpatient medical rehabilitation measures or inpatient medical measures for the purpose of aesthetics are carried out through medical and nursing assistance.
Customs-Treaty-Law:
The competent authority for devices placed on the market under Customs-Treaty-Law is Swissmedic. Further information and the corresponding notification forms can be found on the website of Swissmedic.
EEA-Law:
The competent authority for devices placed on the market under EEA-Law is the Office of Public Health. The following notification forms must be used for notifications.
Due to the parallel marketability (see market access), either the provisions of EEA-Law or Customs-Treaty-Law apply with regard to vigilance. Depending on the law under which the device was placed on the market, either EEA-Law or Customs-Treaty-Law applies.
Customs-Treaty-Law:
In accordance with Art. 66 of the Swiss Medical Devices Ordinance (MedDO) and Art. 59 of the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO), manufacturers and persons who assemble systems or procedure packs, or their authorized representatives where applicable, are responsible for reporting serious incidents, field safety corrective actions (FSCA) and trend reports.
Swissmedic is responsible for processing vigilance reports for devices placed on the market under Customs-Treaty-Law.
Further information on the reporting modalities can be found on the website of Swissmedic.
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 (FSCAs) and trend reports.
For devices placed on the market under EEA-Law, the Office of Public Health is responsible for processing vigilance reports. Until EUDAMED is operational, information is exchanged by e-mail to medical.devices@llv.li. The European agreed notification forms that can be downloaded from the website of the European Commission must be used for the reports.