In vitro diagnostics (IVDs) are used to analyse biological fluids, secretions, and tissues externally (in vitro). Examples of IVDs encompass quick COVID-19 assays and blood testing for the early identification of cancer. They are used every day in hospitals, labs, and medical practices, as well as by individuals in the form of self-administered tests. In 2017, the European Union decided to amend the regulations for IVDs and medical devices to elevate product quality and safety. Switzerland has enacted comparable regulations to maintain the same standard of patient safety.

When the regulatory requirements were revised in 2017, deadlines were set for the transition to the new legal requirements for IVDs. Upon the expiration of the transition periods, all IVDs must adhere to the new legal stipulations; failure to do so may result in their prohibition from sale in Switzerland and the EU. Already before the beginning of the COVID-19 pandemic, it has become evident that the timelines are inadequate to satisfy the increased standards for all items, whereby the pandemic even intensified this problem of deadlines. The EU has consequently resolved to prolong the transition periods under specific conditions to mitigate the risk of supply shortages of IVDs.

To mitigate this risk in Switzerland and to ensure legislative equivalence with the EU, the Federal Council resolved at its meeting on 20 November 2024 to integrate the new transitional periods from the EU decision into to Swiss law and to adapt the Ordinance on In Vitro Diagnostic Medical Devices (IvDO), accordingly effective 1 January 2025. In addition, the simplified labelling requirements for certain IVDs will be continued indefinitely. In its press release, the Federal Council also informed that the already established requirement to register medical devices and IVDs in a central database will come into force on 1 July 2026.