On 28th December, 2023 Switzerland's Swissmedic released an updated information sheet "Clinical Investigations with Medical Devices" that provides guidance on the authorisation process, reporting requirements of sponsors, and the surveillance of clinical investigations by the Swiss Agency for Therapeutic Products, Swissmedic.
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.
This guidance is intended for sponsors of clinical investigations of devices, contract research organisations (CROs), and investigators. Medical devices include, for example, implants, therapeutic devices, diagnostic devices for use on patients and other products, but neither medicinal products nor transplant products with living cells.
The applicable procedure for approval of a clinical investigation depends on the categorisation.
Category A clinical investigation: Such investigations are often termed "post-market". The investigational devices may be placed on the Swiss market (i.e. the CE mark has been obtained) and the devices will be used exclusively as stated in the CE-marked instructions for use
Category C clinical investigation Such investigations are often termed "pre-market". The medical device bears either a CE-marking but will not be used in accordance with the CE-marked instructions for use (off-label use, Category C1), or is not CE-marked (Category C2), or its placing on the market or use is prohibited in Switzerland (Category C3).
To know more about Validation, Review and authorisation, etc click this LINK.
Also checkout this Information sheet "Performance studies with IVD" released by Swissmedic intended for sponsors of performance studies with IVD, contract research organisations (CROs), and investigators that provides guidance on the authorisation process, reporting requirements of sponsors, and the surveillance.
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