benefit-risk determination
Definitions over time (1)
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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:
‘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;
Other definitions of this term in this act (1)
Each has its own scope, dates and uses. Open one to see when it applies.
Used in (0 places in 0 provisions on 12/11/2026)
No text uses this concept on 12/11/2026.