TEAM NB Publish Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment
Team-NB has published a new guidance document outlining harmonised Notified Body expectations for demonstrating the safety and performance of reagent devices intended for use in combination with other devices, equipment, or instruments. The document clarifies key considerations for ensuring compliance with Regulation (EU) 2017/746 (IVDR). It is intended to support and complement the existing Team-NB ...
Team NB Publish Position Paper on MDR/IVDR Revision
Team-NB has released a position paper addressing the European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The paper acknowledges that the proposed changes present opportunities to enhance predictability, transparency, and efficiency within the conformity assessment process. Notified Bodies (NBs) broadly support these objectives and recognise that the ...
