Registration of medical devices in Switzerland: Swissdamed to be functional in 2024 Without a mutual recognition agreement between the European Union and Switzerland, medical devices and IVD…
Swissmedic inspects Class I manufacturers in Switzerland: results of market surveillance activities Since 26 May 2021, manufacturers of class I medical devices must comply with the Swiss…
Latest changes in the EU: how the new transitional provisions impact the Swiss Medical Devices Ordinance The initial transition periods foreseen by the Medical Devices Regulation (MDR) for legacy devices were…
Switzerland to accept FDA approved medical devices On November 28, 2022, the Swiss Parliament reached a key decision by instructing the Swiss…
Swiss Database on Medical Devices, what to know? Swissdamed, which stands for “Swiss Database on Medical Devices”, is a new database implemented by…
New rules on performance studies with IVD in Switzerland On May 26, 2022, the new Ordinance on In Vitro Diagnostic Medical Devices (IvDO SR…
All the Swiss IVD Ordinance (IvDO) deadlines you need to remember Progressive Rollout dates On May 4, 2022, Swiss legislator has officially adopted the new Swiss…
The Swiss Single Registration Number (CHRN) The CHRN - also known as Swiss Single Registration Number - is a unique identification…
Medical device supply in Switzerland – Swiss MedTech raises concerns According to the latest Swiss MedTech survey, Switzerland is expecting a shortage of up to…
Swiss Authorities publish FAQ on Medical Devices The Swiss Agency for Therapeutic Products - Swissmedic - has published on their website a…