MDCG notice on the impact of genetic variants on SARS-COV-2 IVD medical devices

The European Medical Devices and Coordination Group (MDCG) has endorsed a notice on the impact of genetic variants on SARS-COV-2 IVD medical devices.

The notice (MDCG 2021-7) is addressed to manufacturers and authorised representatives of in vitro diagnostic medical devices (IVDs) with the intended purpose of detecting and/or quantifying markers of SARS-CoV-2 infection.

The notice underlines manufacturers’ responsibilities to continually assess the impact of newly identified genetic variants of SARS-COV-2 on the capability of their IVDs to meet their performance, risk and safety claims.

The IVD Working Group (IVD WG) encourages reference to this document by members of industry, EU manufacturers, and authorised representatives of third country manufacturers.

Source:

MDCG website

HPRA website