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
