In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC

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In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC


On May 26, 2022, the In Vitro Diagnostic Medical Device Regulation (IVDR at EU level) and in Switzerland the revised Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on IVD performance studies.

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NO to the ban on animal and human experimentation: swissethics rejects the federal popular initiative «Yes to the ban on animal and human experiments» of February 13, 2022


The Federal Act on Research involving Human Beings (HRA) thoroughly regulates clinical trials and research projects in Switzerland. swissethics is committed to clinical research that meets the highest ethical and scientific standards.

Acceptance of the initiative would create ethically questionable situations. All clinical trials would then be banned in Switzerland, medical care in Switzerland would be put at risk and patients would no longer benefit from new medicines and medical innovations. This is ethically unacceptable.

swissethics supports the positions of unimedsuisse, SAMW and SCTO. These provide further information and arguments on the compelling need to reject this initiative (in German link, in French link).

Comprehensibility as an ethical dimension


The comprehensibility of the patient information and consent forms is a prerequisite for good, fair and correct information concerning participation in clinical trials and research projects. Unfortunately, not all such documents submitted to ethics committees fulfil this requirement to the desired and necessary extent.

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Position paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products


The development of novel technologies and digitalization in the field of therapeutic products offers new opportunities. Through the use of these technologies in clinical trials, it is possible that study visits do not always have to be carried out in the hospital, but can also take place at home.

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swissethics publishes the updated templates of the protocols for research projects of further use


The further use of data and samples for research purposes accounts for an increasingly growing proportion of all research projects conducted in Switzerland. Questions on Big Data and data sharing, e.g. also in the context of large national projects such as SPHN, are often in the foreground.

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