Devices for screening

Screening tests are used on people who appear healthy, so a wrong result reaches many people who had no reason to suspect a problem. MDCG 2020-16 also counts tests that check blood, tissues or organs for transmissible agents before transfusion or transplantation as screening, which places them among the highest-risk IVDs.

are used to detect the presence of or the predisposition to a disease, disorder or other physiological state in a specimen from an individual, embryo or foetus not demonstrating clinically evident symptoms. Depending on the nature of the condition and the targeted patient population, screening devices may be used routinely or may be restricted to "at risk" patients. This also includes (for example) devices intended to assess the suitability of blood, blood components, cells, tissues or organs, or in any of their derivatives for transfusion, transplantation or cell administration, with respect to transmissible agents.

MDCG 2020-16 Rev.5, Section 2, Definitions