MDCG 2021-21 Rev.1 Performance Eval of SARS-CoV-2 IVDs ✅
The European Commision has published Revision 1 of “MDCG 2021-21 : Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices".
🔗 Original Document : https://ec.europa.eu/health/system/files/2022-02/mdcg_2021-21_en.pdf