The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD).
