The IVDR refers to class D devices in rules 1 and 2 of Annex VIII as follows: Devices intended to be used for the following purposes are classified as class D:
- detection of the presence of, or exposure to, a transmissible 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;
- detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation;
- determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.
[Definition according to MDCG 2022-3 No. 3.1, also complies to definition under (EU) 2017/746 Article 47(I) & Annex VIII Section 2 Rule 1]