Self-tests for coronavirus, an article from Politico
https://www.politico.com/news/2020/08/14/the-breakthrough-that-could-halt-the-pandemic-even-before-a-vaccine-395179
Team-NB approved a new Position Paper on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical DeviceQuality Management System Regulation and ISO 13485 Audit Reports (TCP III) thanks to the preparation of the TCP task force members.
List of COVID-19 essential Medical Devices (MDs and IVDs) available from now
NBM-036-20 List of COVID-19 essential Medical Devices final
This rolling plan regarding the implementation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746…
... which contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted or intends to adopt in the future has been updated in May and made available. NBM-034-20 Rolling plan_June 2020_EXT
Team-NB applied to the CORE-MD project as a consortium partner.
The project is aimed to develop methodological approaches for improved clinical investigation and evaluation of high-risk medical devices.