serious adverse event

Defined in Article 2, Medical Device Regulation (MDR)

Definitions over time (2)

1. 24/04/2020 – today applies on 12/11/2026 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;

2. 05/05/2017 – 25/05/2017 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;

Used in (16 places in 8 provisions on 12/11/2026)

Medical Device Regulation (MDR) (16 in 8)

Recital 46 · Recital 79 · Article 2 · Article 73 · Article 80⁶ · Article 81² · Article 120 · Annex XV³