MDCG 2022-3 Verification of Class D IVDs 📚
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