Clinical data

Only the listed sources count, such as clinical investigations, literature on the device or an equivalent device, and post-market surveillance data. Bench tests and simulations are not clinical data, however strong they are.

‘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;

EU MDR, Article 2(48)