New Regulations Applicable to In Vitro Diagnostic Medical Devices

On 26 May 2022 the Swissmedic announced the entry into force of the new regulations on in vitro diagnostic medical devices.

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 aim of the new regulations is to improve patient safety by means of stricter requirements for conformity assessment and post-market surveillance. The new legal requirements enter into force on 26 May 2022, at the same time as the application of the IVDR in the EU. From 26 May 2022, clinical trials with in vitro diagnostic medical devices will be regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).

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