Anyone placing medical devices on the Swiss market as a manufacturer or distributor must report all incidents to Swissmedic.Further information can be found via the following link:
New form for reporting serious incidents for manufacturers & placers on the market
On 19 December 2018 the European Commission published the new form for reporting serious incidents (link). This can be used for submitting reports to Swissmedic with immediate effect.
Swissmedic made the new form available on its web page.
Once the one-year transition period has elapsed, reports will no longer be accepted on the old form (Rev. 7).
The old form can be downloaded from the website of the European Commission: Old form
Last modification 08.03.2019