The Federal Council has decided to amend the Ordinance on In-vitro Diagnostics (Verordnung über In-vitro-Diagnostika, IvDV) and extend the transition periods for compliance with the new requirements, in alignment with European Union (EU) regulations, until early 2025. This amendment primarily affects the certification process for In-vitro Diagnostics, such as Covid-19 rapid tests, for which the original deadlines were deemed insufficient. The adjustment aims to mitigate the risk of supply shortages and ensure regulatory harmonization with the EU.

Furthermore, the simplified labeling requirements for certain In-vitro Diagnostics, which are not intended for self-use, will be continued indefinitely. This provision, in effect since May 2022 for products from Switzerland, facilitates trade and ensures supply chain stability. The permanent regulation will enter into force on 1 January 2025.

Under the current provisions of the Medical Devices Ordinance (Medizinprodukteverordnung, MepV) and IvDV, all medical devices and In-vitro Diagnostics are required to be registered with Swissmedic. Beginning on 1 July 2026, this registration obligation will be enforced through the «Swiss Database on Medical Devices» (swissdamed), developed by Swissmedic. This measure is designed to enhance transparency and strengthen market surveillance. Certain sections of the new database will be available for voluntary registration starting in 2025.

For more information, see here.