The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) came into force on 1 January 2025, implementing the extended transitional periods in accordance with the European Union (EU) regulation, thereby restoring regulatory equivalence with the EU.

In 2024, EU Regulation 2024/1860 was enacted, making amendments to EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (EU-IVDR) regarding transitional provisions for certain in vitro diagnostic medical devices, as well as to EU Regulation 2017/745 on Medical Devices (EU-MDR) and the EU-IVDR for the phased introduction of the European database on medical devices (EUDAMED). These amendments extend the validity of certificates issued under the old legislation in the EU, addressing bottlenecks at notified bodies. Additionally, the labelling requirements for products intended for professionals were simplified to ensure the continued supply of In Vitro Diagnostics (IVDs) in Switzerland.

Healthcare institutions are also granted additional time to demonstrate that their «In-House Products» or «Laboratory Developed Tests (LDTs)» cannot be replaced by comparable CE-marked market products. This obligation now comes into effect on 31 December 2030, instead of the originally scheduled date of 26 May 2028.

However, the new reporting obligation for manufacturers according to art. 10a EU-MDR and EU-IVDR, requiring notification of the interruption or discontinuation of the supply of certain medical devices, is not part of this revision of the Swiss ordinances.

For more information, see here.