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

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Annual reports and other publications of swissethics

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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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Publication in Jusletter: Human research, further use and informed consent

02.02.2021

swissethics was mandated by the FOPH, Human Research Section, in 2020 to prepare a structured analysis on the further use of health-related personal data and biological material and the application of Article 34 HRA (link to the report in German).

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swissethics publishes recommendations on research adapted to gender

16.12.2020

Gender equity in research is an important issue: there are significant differences between men and women in many clinical drug trials, as well as in non-clinical trials with persons or in research projects of further use of health-related personal data and biological material.

The published recommendations address essential steps towards equitable research between the sexes, with ethics commissions playing an important role in the evaluation of the applications.

The recommendations are published in German and French.

Guidance document on the use of food stuffs and food supplements in research

07.12.2020

swissethics has published a short guidance document regarding the use of food stuffs and food supplements in research. These products could be classified as investigational medicinal products (IMP) according to ClinO, in which case they would have to be made according to GMP and be submitted to the ethics committee and Swissmedic.

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Information on the coronavirus: new and updated document “Joint guidance document on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic”

05.11.2020

Due to the current situation, changes were introduced in the document “Joint guidance of swissethics - Swissmedic on the conduct of clinical trials during COVID-19 pandemic”. Details related to the changes are outlined in the guidance paper.