Devices intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers:
- ABO system [A (ABO1), B (ABO2), AB (ABO3)];
- Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
- Kell system [Kel1 (K)];
- Kidd system [JK1 (Jka), JK2 (Jkb)];
- Duffy system [FY1 (Fya), FY2 (Fyb)]
Note: Please see MDCG 2020-167 (Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746) for examples of devices falling in Class D.
[Definition according to MDCG 2022-3 No. 3.1, also corresponds to definition under (EU) 2017/746 Annex VIII Section 2 Rule 2]