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.
Permanent link of this page
www.swissmedic.ch/
md-clinicaltrials-en

Forms and templates

Forms for clincial inestigations of medical devices

Forms for interventional performance studies with in vitro diagnostics

Forms for combined studies (a clinical trial of a medicinal product/ATMP conducted in parallel with a clinical trial of a medical device/IVD)

General forms

Templates

Last modification 16.05.2023

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