MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices

The Medical Devices Coordination Group (MDCG) has published the notice MDCG 2022-1 for manufacturers of in vitro diagnostic medical devices (IVDs), established in countries outside the EU or the EEA, who place or intend to place on the EU market IVDs intended to detect and/or quantify markers of SARS-CoV-2 infection.

This notice aims to highlight a number of common issues that EU national competent authorities have identified during their market surveillance activities regarding the compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC. These issues may also be relevant for SARS-CoV-2 devices that are in transition to Regulation (EU) 2017/746.

DOWNLOAD THE NOTICE MDCG 2022-1