Glossary

Serious public health threat [MDR/IVDR]

MDR IVDR

‘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.

 

[Definition under (EU) 2017/745 Article 2 No. 66 also corresponds to definition under (EU) 2017/746 Article 2 No. 69]