clinical evidence

Defined in Article 2, Medical Device Regulation (MDR)

Definitions over time (2)

1. 24/04/2020 – today applies on 12/11/2026 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

   ‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

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 evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

Used in (21 places in 8 provisions on 12/11/2026)

Medical Device Regulation (MDR) (21 in 8)

Recital 71 · Article 2 · Article 61⁴ · Article 81 · Annex IX⁸ · Annex VII · Annex X² · Annex XIV³