MDCG 2022-1 – Notice to 3rd country manf. of SARS-CoV-2 IVD 📚

The Medical Device Coordination Group #MDCG has published a new document on “Notice to Third Country Manufacturers of SARS-CoV-2 In Vitro Diagnostic Medical Devices”

 The document provides a brief overview of:

-          Designation of an authorised body

-          Involvement of NB for self-tests

-          Translations of IFU/label

-          SAR-Coov-2 Performance Evaluation

-          Transition to MDR

 🔗 Original Document :  https://ec.europa.eu/health/system/files/2022-01/mdcg_2022-1_en.pdf