Team-NB members adopted, at the unanimity of the presents, a common paper aimed at describing in detail the pre-application and application and Post application phases processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/746 (IVDR).
Team-NB-PositionPaper-IVDR-Certification-Process-Consensus-Document-V1-20250409