Notice to Manufacturers on SARS-COV-2 Tests and Genetic Variants

News Category: Regulatory news

Date: 18/05/2021

The European Commission Medical Devices Coordination Group (MDCG) has endorsed a notice addressed to manufacturers and authorised representatives of in vitro diagnostic medical devices (IVDs) for SARS-COV-2. The notice is available to download from the website of the European Commission.

The notice underlines the 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.

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