Serious public health threat

This is the most urgent vigilance category in the EU, with the shortest reporting deadline for manufacturers. It covers events that may affect many people or are unusual for the time and place, not only single-patient outcomes.

‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;

EU MDR, Article 2(66)

‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;

IVDR, Article 2(69)