The Medical Device Coordination Group (MDCG) has issued a guidance document MDCG 2021-7 for manufacturers of in vitro diagnostic medical devices that relate to SARS-CoV-2.
The scope is defined as follows:
“This notice is 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, as well as their authorized representatives. The notice underlines the manufacturers’ responsibilities to continually assess the impact of newly identified genetic variants of SARS-CoV-2 on the capability of those IVDs to meet their performance, risk and safety claims.”
Among others, manufacturers are required to continually assess the impact that new genetic variants may have, to ensure that the performance of their devices continues to meet the essential requirements set out in the IVDD.
Please review the guidance document in detail and make sure that the corresponding requirements are fulfilled. Please note also that we require updates of your technical documentation to maintain the current registrations.
Source: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-7_en.pdf