clinical data

Definitions over time (1)

25/05/2017 – 24/04/2020 Article 2, Medical Device Regulation (MDR) Scope: Whole act

For the purposes of this Regulation, the following definitions apply:

‘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;

Each has its own scope, dates and uses. Open one to see when it applies.

No text uses this concept on 11/11/2026.