August 2020
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
July 2020
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.
June 2020
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 [...]
Team-NB applied to the CORE-MD project as a consortium partner.
The project is aimed to develop methodological approaches for improved [...]