The Medical Device Coordinator Group #MDCG has published a document “MDCG 2022-3 : Verification of manufactured class D IVDs by notified bodies”

 It provides guidance to notified bodies regarding their responsibilities for samples of manufactured Class D devices (or batches) in accordance with Annexes IX and XI of the IVDR.

 🔗 Original Document :  https://ec.europa.eu/health/system/files/2022-02/mdcg_2022-3_en.pdf