Medical-Diagnostic Devices: News on Swiss Regulation.
The Federal Council has decided to extend the deadline for in vitro diagnostic medical devices (IVDs) to comply with new requirements, thus keeping Switzerland in line with EU regulations. These devices, crucial for examinations such as COVID-19 tests or blood tests, will continue to be subject to strict controls to ensure safety and quality.
In addition, the simplified labeling requirement for some DIVs will be maintained indefinitely, facilitating distribution in the Swiss market and ensuring supply. From 2026, all medical devices will have to be registered in a central database, developed by Swissmedic, to ensure greater transparency and control in the market.
