The technical specifications are clearly structured for different product categories in the form of 13 annexes. The test methods covered by the regulation include tests for the detection of blood group antigens for the blood group systems ABO, Rh, Kell, Duffy and Kidd, the human immunodeficiency virus (HIV), the hepatitis C virus (HCV), hepatitis B virus (HBV), hepatitis D virus (HDV), Creutzfeldt-Jakob disease (vCJD), cytomegalovirus (CMV), Epstein-Barr virus infection (EBV), Treponema pallidum, Trypanosoma cruzi and severe acute respiratory syndrome infection coronavirus 2.
The following transition period applies:
From 25 July 2024 this Regulation will be binding in its entirety and directly applicable in all Member States.
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