clinical performance
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:
‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;
Other definitions of this term in this act (1)
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Used in (0 places in 0 provisions on 12/11/2026)
No text uses this concept on 12/11/2026.