MDCG 2021-21 : Guidance on Performance Evaluation of SARS-CoV-2 IVDD📰

The #MDCG has released a new guidance regarding SARS-CoV-2 In Vitro diagnostic medical devices. This covers a variety of considerations, including those related to interference, cross-reactivity, sensitivity/specificity, and bench testing.

Specific considerations include various types of assays, antigen tests, and nucleic acid amplification techniques.

🔗 Original document here  :  https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-21_en.pdf

#MDRG #mdrguide #IVDR #MDR #medicaldevices #ec