EC: Common Specifications for Certain High-Risk IVDs
On 4 July 2022 the European Commission published the Implementing Regulation (EU) 2022/1107 to establish common specifications for certain class D in vitro diagnostic medical devices considered to be high-risk. These relevant harmonised standards had already been partially introduced in the repealed Directive 98/97/EC. Now the specifications have been updated and adapted to the state of the art.
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 2022 until 25 July 2024, devices that are in conformity with the common technical specifications set out in Decision 2002/364/EC shall be presumed to be in conformity with the requirements regarding the performance characteristics set out in Section 9.1 of Annex I to Regulation (EU) 2017/746.
- For devices not complying with those common specifications, it shall be duly justified that a level of safety and performance at least equivalent to that of the common specifications can be ensured.
From 25 July 2024 this Regulation will be binding in its entirety and directly applicable in all Member States.
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