MedDO on products without an intended medical purpose
In November 2023, the Swiss Medical Devices Ordinances (MedDO and IvDO) were revised to guarantee…
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…