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Medical Device Coordination Group (MDCG) issues note to COVID IVD Manufacturers

By January 14, 2022No Comments

The Medical Device Coordination Group (MDCG) has endorsed a notice addressed to manufacturers of in vitro diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection that are based in countries outside the EU or the EEA and that place or intend to place the abovementioned devices on the EU market.

The notice is intended to highlight a number of common issues that EU national competent authorities have identified in the course of their market surveillance activities regarding compliance of SARS-CoV-2 IVDs 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 which are transitioning to IVD Regulation (EU) 2017/746.

For more information, you can access the document online.

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