Life-threatening

MDCG 2020-16 uses the term when applying the IVDR classification rules, where the risk of a life-threatening disease or situation can place a test in class C or D. The guidance looks at what the condition generally leads to, so it describes the condition rather than the outcome for one patient.

are diseases, conditions or situations that in general result in death. These are often untreatable, treatment options are limited or require major medical interventions.

MDCG 2020-16 Rev.5, Section 2, Definitions (modified from Health Canada guidance, 2016)