On November 20, 2024, the Swiss Federal Council decided to align the In-Vitro Diagnostics Ordinance (IvDO) with the updated EU transition periods. This step aims to minimize the risk of supply shortages.
Extension of Transition Periods for IVD Certification
The deadlines for transitioning to new legal requirements for in vitro diagnostics (IVDs) in Switzerland and the EU have proven insufficient for all products to comply. To address this, the EU extended the transition periods under specific conditions to minimize the risk of supply shortages. To ensure equivalent legislation and prevent supply bottlenecks in Switzerland, the Federal Council has decided to adopt the EU’s extended transitional periods into the Swiss In Vitro Diagnostics Ordinance (IVDO). This change will come into force on January 1, 2025.
Simplified Labeling Requirements Made Permanent
The temporary simplification of labeling requirements for certain IVDs, which are not intended for self-testing, will become permanent. This measure reduces costs and facilitates the distribution of these products in the Swiss market.
Mandatory Product Registration Effective 2026
The requirement to register medical devices and IVDs in the Swissmedic database (swissdamed) will come into force on July 1, 2026. Certain parts of the database are already available on a voluntary basis.
These adjustments ensure patient safety and the continued availability of in-vitro diagnostics in Switzerland.
This information is currently only available in German, Italian, and French language on the Swissmedic website.