‘Clinical data’ means 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.
[Definition according to (EU) 2017/745 Article 2 No. 48]