clinical benefit

Defined in Article 2, Medical Device Regulation (MDR)

Uses as of 27/05/2018

Definitions over time (1)

1. 25/05/2017 – 24/04/2020 applies on 27/05/2018 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

   ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;

Used in (20 places in 8 provisions on 27/05/2018)

Medical Device Regulation (MDR) (20 in 8)

Article 2⁴ · Article 61 · Article 62 · Article 71 · Article 89 · Annex I³ · Annex XIV² · Annex XV⁷