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Swiss Medic: Information sheet on Clinical Investigations with Medical Devices

Recently (13-April-2023) Switzerland's Swissmedic released an updated Information sheet document for "Information sheet on Clinical investigations with Medical Devices".

'Clinical trial' in Swiss legal texts is an umbrella term used for clinical investigations with medical devices, performance studies with IVD, clinical trials of medicinal products, and clinical trials conducted with other interventions (e.g. surgical interventions, other therapies).

A clinical investigation with a medical device is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

Swiss human research law regulates biomedical research on human subjects based on internationally recognized principles. In particular, it shall ensure that the investigational medical device is at an adequate stage of development for its intended use on humans, that scientific and ethical criteria are met, and that human subjects' dignity, personality, and health are protected.

Click this LINK to more about the Authorisation of clinical investigations with medical devices and Review and surveillance activities by Swissmedic, etc.

Also, there was another Information sheet Performance Studies with In vitro diagnostic (IVD) that was updated and released on the same day. Click this LINK to know more on topics like Submissions during performance studies (notification duties, authorisations).


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