Amendment to the Ordinance on In Vitro Diagnostic Medical Devices

Protection of human health or safety (TBT); Harmonization (TBT)

In vitro diagnostic medical devices

Link to ePing

11.100.10 - In vitro diagnostic test systems; 11.100.10 - In vitro diagnostic test systems

Human health; Human health

Content of changed notified measures are summarized as follows: In order to improve the safety and quality of medical devices, Switzerland adapted its legislation on medical devices in line with developments in EU law (Medical Devices Regulation, MDR and In vitro Diagnostic Medical Devices Regulation, IVDR). The new legislations in Switzerland are applicable since May 2021 for medical devices (MedDO) and May 2022 for in vitro diagnostic medical devices (IvDO) like in the EU.Transitional measures were notified to the WTO (G/TBT/N/CHE/258/add.1). Additional flexibilities for labeling requirements to IVD products that are not intended to be self-diagnosis are currently a temporary rule. The proposal foresees to adopt these flexibilities for labeling requirements as a permanent rule. In addition, on 13 June 2024, Regulation (EU) 2024/1860 amending the EU-MDR and the EU-IVDR entered into force in the EU and provides in particular for an extension of the transitional periods in the EU provided for in the IVDR and a gradual roll-out of Eudamed. The extended transitional periods in the IVDR as well as the applicable conditions for their extensions are transposed into the corresponding Swiss legislation to maintain the equivalence with the European regulation as regards the transitional periods. The registration of Unique Device Identification (UDI) number with the Swiss authorities will become mandatory by July 1st 2026.

1:File here 2:File here

EN:File here

Active Inactive