serious incident
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:
‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following: the death of a patient, user or other person, the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, a serious public health threat;
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.