Clinical data

information concerning safety or performance that is generated from the use of a device and is sourced from the following:
clinical investigation(s) of the device concerned,
—clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
— reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
— clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;

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