In vitro diagnostic medical devices - common specifications | Feedback period 09 February 2022 - 09 March 2022

These common specifications for certain class D (highest risk) in vitro diagnostic medical devices set uniform and consistently high requirements for device performance across the Union.

The devices covered are those for detecting and/or quantifying HIV, human T-cell lymphotropic virus, hepatitis B, C, D, vCJD, cytomegalovirus, Epstein-Barr virus, Treponema pallidum (syphilis), Trypanosoma cruzi (Chagas disease) and SARS-CoV-2 and for determining ABO, Rhesus, Kell, Kidd and Duffy blood groups.

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