Materiovigilance: information for manufacturers of medical devices/persons or companies who place medical devices on the market

Concerns serious incident reports and field safety corrective actions (FSCAs)

16.09.2015 - Swissmedic would like to make you aware that, as of 1 October 2015, it will only accept the following formats for serious incident reports and FSCAs:

For each vigilance report, please e-mail the active PDF provided by the European Commission under MEDDEV 2.12-1 guidelines and the accompanying xml file to

You can find the English PDF on our website at:

Thank you for your assistance.