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

News Category: Regulatory news

Date: 01/02/2022

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.

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