clinical data

Defined in Article 2, Medical Device Regulation (MDR)

Definitions over time (2)

1. 24/04/2020 – today applies on 11/11/2026 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;

2. 05/05/2017 – 25/05/2017 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;

Used in (37 places in 11 provisions on 11/11/2026)

Medical Device Regulation (MDR) (37 in 11)

Recital 63 · Article 2³ · Article 61⁶ · Article 62 · Article 75 · Article 106 · Annex II · Annex IX² · Annex VII⁶ · Annex XIV¹² · Annex XV³