Users & Operators

Incidents

Anyone who uses or operates medical devices professionally must report incidents to Swissmedic.

The procedure for submitting reports and the purpose of reports are described in the following fact sheet.
It is not always easy to decide whether an incident should be reported. Our decision-making tree can help you answer this question:
Here are a few examples of notifiable incidents from everyday hospital practice:
You can report incidents direct to Swissmedic via the following link.
The following link leads to a publication on the subject of "Reporting incidents – an important contribution by hospitals to patient safety".
The link below takes you to an article from Competence (H+ Hospital Forum) magazine on incidents involving medical devices and a comparison of hospitals' reporting obligations.
(Article in German, Summary in French)

Materiovigilance contact person in hospitals

Hospitals are legally obliged to set up a materiovigilance system. As part of this obligation, they must designate someone to be responsible for materiovigilance (materiovigilance contact person) and notify this person to Swissmedic.

An information brochure on materiovigilance in hospitals can be found below:

New materiovigilance contact persons or changes in the contact details of existing registered contact persons must be notified to Swissmedic. This should be done by completing the following form and sending it to: materiovigilance@swissmedic.ch:

The following information sheet provides specific information about materiovigilance contact persons

Swissmedic also conducts materiovigilance reporting inspections in hospitals. The following document lists key points that may arise during an inspection. It also describes how an inspector might proceed.
Documents from conferences or courses for contact persons can be found here:

Recalls and other safety measures (Field Safety Corrective Actions (FSCAs)

A list of recalls and other safety measures can be found under "News".

https://www.swissmedic.ch/content/swissmedic/en/home/medizinprodukte/vorkommnisse---fsca-melden--materiovigilance-/anwender---betreiber.html