On 4 May 2022, the Federal Council adopted the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and the amendment to the Ordinance on Clinical Trials with Medical Devices (CTO-MedD). The new legal requirements entered into force on 26 May 2022, at the same time as the application of the IVDR in the EU. Since 26 May 2022, clinical trials with in vitro diagnostic medical devices have been regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).
The aim of the new regulations is to improve patient safety through the introduction of stricter conformity assessment procedures and performance studies, which ensure the safety and quality of in vitro diagnostic medical devices. In addition, new requirements apply for monitoring, traceability and transparency following placement on the market.
At the online information event, we will cover the new and changed requirements and clarify the specifications in Switzerland.