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

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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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Federal Council breaks off negotiations on the institutional agreement with the EU: Consequences for the clinical research of medical devices in Switzerland

31.05.2021

On May 26, the Medical Device Regulation (MDR) at EU level and in Switzerland the ordinance for clinical trials of medical devices (ClinO-MD) came into force. At the same time, Switzerland broke off the negotiations on the framework agreement with the EU.

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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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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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