Please note this is an extract of the original bulletin.
Devices manufactured and used in healthcare institutions
General information and notes on in-house devices according to MedDO and IvDO
New information on submitting vigilance reports for medical devices
Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219)
Revision of MedDO and IvDO
When the changes entered into force on 1 November 2023, Swissmedic updated its website in this regard and published implementation guides
Swissmedic reviews Swiss importers
Swissmedic reviewed 30 importers of medical devices for compliance with legal requirements
