serious incident

Defined in Article 2, Medical Device Regulation (MDR)

Uses as of 01/12/2018

Definitions over time (1)

1. 25/05/2017 – 24/04/2020 applies on 01/12/2018 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;

Used in (47 places in 18 provisions on 01/12/2018)

Medical Device Regulation (MDR) (47 in 18)

Recital 46 · Recital 75 · Recital 76² · Recital 77 · Recital 79 · Article 2² · Article 10 · Article 27 · Article 83 · Article 87¹⁴ · Article 88 · Article 89¹¹ · Article 91³ · Article 92² · Annex I · Annex III² · Annex IX · Annex XIII