serious adverse event

Definitions over time (1)

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 adverse event’ means any adverse event that led to any of the following: death, serious deterioration in the health of the subject, that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, hospitalisation or prolongation of patient hospitalisation, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, chronic disease, foetal distress, foetal death or a congenital physical or mental impairment or birth defect;

Each has its own scope, dates and uses. Open one to see when it applies.

No text uses this concept on 12/11/2026.