COVID-19 Taskforce – BIVDA Newsletter

COVID-19 Taskforce

CTDA Lessons Learnt webinar on 21 March – Slides and Recording

A Lessons Learnt webinar on the COVID-19 test validation approved products (CTDA) process took place on 21 March. A recording of the meeting is available here. To access it, you will need to enter the password: CTDAWebinar Presentation slides from the webinar are available for download here.

MichaelApril 1, 2022

January 14, 2022 in COVID-19 Taskforce, COVID-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…

December 17, 2021 in COVID-19 Taskforce, COVID-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.…

October 29, 2021 in COVID-19 Taskforce, COVID-19 Taskforce Archive

Slides from the BIVDA-ABHI Joint Webinar on the COVID test desktop validation

The slides from Thursday's joint webinar hosted by BIVDA and ABHI on CDTA updates regarding the COVID test desktop validation process can be found here.

October 1, 2021 in COVID-19 Taskforce, COVID-19 Taskforce Archive

BIVDA Responses to COVID-19 Antigen & Molecular Test Lab Validation Consultation

Please find here the responses to the COVID-19 test validation consultation from BIVDA. ***Many questions require input from companies directly and we couldn't answer these generically.