What is a Notified Body?
A Notified Body (NB) is an entity accredited by the Competent Authority of a European Union (EU) Member state to act as a third party assessor of manufacturers’ compliance with applicable EU regulation for certain products prior to market entry.
A Notified Body governs the CE marking process by assessing the conformity of medical devices and In Vitro Diagnostics devices with the appropriate European Regulations EU 2017/745 (MDR) to replace both the MDD and the AIMDD, and the EU 2017/746 (IVDR) to replace the IVDD. Under these regulations, Notified Bodies will perform conformity assessment based on the quality management system and assessment of the technical documentation, type examination, or product conformity verification.