clinical evaluation

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 evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device 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 evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

Used in (143 places in 36 provisions on 12/11/2026)

Medical Device Regulation (MDR) (143 in 36)

Recital 4 · Recital 12 · Recital 20 · Recital 23 · Recital 29 · Recital 33³ · Recital 48 · Recital 49 · Recital 51 · Recital 56² · Recital 57 · Recital 74 · Recital 83 · Article 1 · Article 2³ · Article 5 · Article 8 · Article 9 · Article 10² · Article 32 · Article 44 · Article 45⁴ · Article 54⁵ · Article 61¹⁷ · Article 62² · Article 71 · Article 83 · Article 105 · Article 106⁸ · Annex ES · Annex II² · Annex IX¹⁷ · Annex VII³⁸ · Annex X² · Annex XIV¹³ · Annex XV⁴