Serious incident

Serious incidents trigger vigilance reporting by the manufacturer to the competent authority. The words 'might have led' mean that a near miss with a serious potential outcome can still be reportable, which is easy to miss. In the US the comparable trigger is an MDR reportable event under 21 CFR 803, where MDR means Medical Device Report.

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

EU MDR, Article 2(65)

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

IVDR, Article 2(68)