From 1 July 2026, manufacturers of medical devices and IVDs on the Swiss market will have to ensure that their devices are registered in Swissdamed.…
Swiss authority announces inspections of PMS documentation
On 23 April, Swissmedic announced that they will be conducting a focus campaign of the requirements for post-market surveillance (PMS) of higher-risk medical devices. The…
Switzerland aligns with the EU on new eIFUs regulation
In August 2025, Swissmedic announced to adopt the new EU requirements on eIFUs with immediate effect. With this alignment, it is possible to use electronic…
Swissdamed device registration module is now available
In August 2025, Swissmedic announced the new UDI Devices module in Swissdamed is live. The registration is voluntary and will become mandatory only in July…
2025 deadlines for medtech in the EU, UK, and Switzerland
2025 brings crucial regulatory deadlines for the medtech sector across the EU, UK, and Switzerland. Some of the key dates and requirements that a manufacturer…