The legal requirements for clinical trials with medical devices are changing. In the course of adapting Swiss legislation to the new EU Medical Device Regulation (MDR), clinical research with medical devices (with the exception of in vitro diagnostics) in Switzerland will be regulated in a separate ordinance. The new "Medical Device Regulation" (ClinO-MD) will come into force on 26.5.2021, at the same time as the MDR.
You can find more detailed information here.
The Coordination Office for Human Research (Kofam) is required by law to provide the public with information about the work of the ethics committees. To this end, every year it produces a summary of the annual reports of the individual committees.
The summary of the individual annual reports for 2019 is now available. Because of the corona pandemic, there was a delay in submitting the reports.
Parallel to this, a statistical report has again been published on the type and number of human research projects that have been submitted and approved in Switzerland.
The 2019 summary report and statistical report can be found here:
- Summary of the individual 2019 annual reports of the ethics committees
A brief summary of the key points on human research in Switzerland
All information on the requirement to obtain authorisation, categorisation and submission of applications is available here:
Search for registered clinical trials in Switzerland.
The categoriser provides help in assigning and categorising your research project according to the provisions of the Human Research Act – good preparation for the submission of your application!
The case study module provides a selection of real human research projects, each with a brief summary. The projects can be filtered according to various criteria.
