adverse event
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:
‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;
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.