MDCG 2022-3 Verification of manufactured class D IVDs by ...
The IVDR refers to class D devices in rules 1 and 2 of Annex VIII as follows: ... agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration; ... or analysis of one or more quantities or characteristics to determine the ...
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