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

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MDCG 2021-21 Rev.1 Performance Eval of SARS-CoV-2 IVDs ✅

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Common Specification Class D for IVDR 💥