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ICH adopts E6(R3) guideline on good clinical practices

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Annual reports and other publications of swissethics

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List of documents recently updated by swissethics

News

In memoriam Professor Dr. med. Peter Meier-Abt

31.05.2021

Peter Meier Abt passed away on May 27, 2021. He was a lifelong advocate for medicine in Switzerland and far beyond at universities, at the Swiss Academy of Medical Sciences, and other institutions.

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The Medical Device Regulation (MDR) in the EU and the Ordinance on clinical trials with medical devices (ClinO-MD) in Switzerland came into force

26.05.2021

The Medical Device Regulation (MDR) in the EU and the Ordinance on clinical trials with medical devices (ClinO-MD) in Switzerland came into force today, May 26, 2021.As of today, all new clinical trials with medical devices must be submitted to the Ethics Committee using the new submission form “RESEARCH PROJECT APPLICATION FORM FOR MEDICAL DEVICES”, which meets the requirements of MDR and ClinO-MD.

swissethics publishes a new template of the patient information for the “Re-Consent”

13.04.2021

In clinical trials, sometimes fundamental conditions change in the course of the study, for example when new safety data are available or it is clear that the participants are exposed to a (new) risk. In this case, an amendment is submitted to the ethics committee and the participants must be informed accordingly and give their consent in writing (so-called "re-consent").

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Clinical trials with medical devices: Expected changes in the legal requirements and BASEC

16.03.2021

On May 26, 2021, the Medical Device Regulation (MDR at EU level) and in Switzerland the Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on clinical investigations with medical devices, including investigations on proof of efficacy and safety of medical devices. Hence, many additional documents must be submitted to the ethics committees.

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Clinical trials with medical devices: Expected changes in the legal requirements and BASEC

16.03.2021

On May 26, 2021, the Medical Device Regulation (MDR at EU level) and in Switzerland the Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on clinical investigations with medical devices.
If you are planning to submit a new clinical investigation with a medical device before May 26, 2021, or if you currently have a clinical investigation with a medical device under review by the ethics committee, we strongly advise you to read on the swissethics.ch website how the transition of such investigations is to be regulated. 
Weblinks to the instructions in EnglishGermanFrench and Italian on the swissethics.ch website.

Weblink to the newsletter of April 1st 2021.