A Notified Body (NB) is an organization designated by a national regulatory authority to assess the conformity of medical devices with the applicable regulations and standards. Notified Bodies play a critical role in the European regulatory system for medical devices. They are responsible for conducting conformity assessments and issuing CE certificates for devices that meet the requirements of the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).
Notified Bodies are required to meet strict requirements for competence, impartiality, and independence. They are subject to regular surveillance and oversight by the national regulatory authorities. Manufacturers must select a Notified Body to conduct the conformity assessment for their devices before they can be placed on the market in the European Union.
