Team-NB

MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…

MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…

Team-NB hve published a press release "TEAM-NB Notified Bodies call to action to manufacturers to apply. October 2023" This press release is a call to action to to apply with notified bodies in time especially for high-risk IVD medical devices. It intends to raise awareness with the device manufacturers and other economic operators to apply with notified bodies in time.…

Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as "Team-NB PositionPaper BPG-IVDR V1" on the Team-NB website. Please note that although this is a guidance document published by a collective group of Notified Bodies, it is…