January 11, 2024   Notifying Your European Notified Body About Non-Significant Changes   Europe’s Union MDR (Regulation 2017/745) includes legislative authority (e.g., in Annex VII sec. 4.9) for Notified Bodies (NBs) to require a manufacturer to notify the NB about certain kinds of changes [e.g., QMS, product range, device design (including labeling), intended use or […]