clinical data
as defined in Regulation (EU) 2017/745 of the European Parliament and of the Council of…, Article 2, point (48) (Definitions)
(48)
‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
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clinical investigation(s) of the device concerned,
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clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
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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,
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clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;