Clinical trials of medical devices

The term "clinical trial" covers

• the "clinical investigation" with devices in accordance with the Medical Devices Ordinance (MedDO)
• the "performance study" with devices in accordance with the Ordinance on In Vitro Diagnostic Medical Devices (IvDO)

The Human Research Act (HRA) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD) regulate the requirements for conducting clinical trials. They implement the provisions of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in Swiss law and define national requirements.

ClinO-MD regulates the requirements pertaining to clinical trials:

1. with medical devices and other devices in accordance with Article 1 of MedDO;
2. with in vitro diagnostic medical devices and their accessories in accordance with Article 1 paragraph 1 of IvDO.