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COVID-19 TaskforceCOVID-19 Taskforce Archive

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

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…
January 14, 2022
COVID-19 TaskforceCOVID-19 Taskforce Archive

BIVDA/ABHI Briefing on CTDA Validation requirements regarding COVID Test Applications

Ahead of the 31 December deadline, BIVDA and ABHI are hosting a joint webinar on the latest COVID-19 Test Desktop Validation developments from the CTDA team for live applications. This will take place on Tuesday 21 December from 10am to 11am. Please register your attendance at this page. There is some important information to share with members which may assist in completing outstanding applications.…
December 17, 2021