benefit-risk determination

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:

   ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given 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:

   ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;

Used in (9 places in 5 provisions on 12/11/2026)

Medical Device Regulation (MDR) (9 in 5)

Article 2 · Article 83 · Article 86 · Article 90 · Annex IX⁵