News Category: Regulatory news
The Medical Devices Coordination Group (MDCG) has published a notice addressed to third country manufacturers of in vitro diagnostic medical devices (IVDs) for SARS-CoV-2 (MDCG 2022-1).
This notice highlights common issues identified by EU national competent authorities regarding compliance of SARS-CoV-2 IVDs placed on the market by manufacturers based outside the EU or EEA. The notice explains how the issues affect compliance with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.
These issues can also be relevant for SARS-CoV-2 devices transitioning to Regulation (EU) 2017/746.