The Notified Body: The Conformity Assessment Body for Medical Devices in Europe

A Notified Body (NB) is a conformity assessment body designated under the
Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation
(IVDR 2017/746) that assesses the conformity of medical devices for CE
marking before they enter the European market. The European member state in
which a Notified Body is to be located is responsible for enforcing the organization,
quality management, resources and procedural requirements for the Notified
Body specified in these regulations. Once a Notified Body is designated, it carries
out the conformity assessment activities according to the requirements of a
chosen conformity assessment procedure that includes quality management system
auditing, product testing, review of technical documentation, preclinical and
clinical evaluation assessment, IVD performance evaluation assessment, and
special procedures, if applicable.
In this chapter, we present in detail what a Notified Body is in the sense of the
aforementioned regulations and what special requirements are placed on designated
notified bodies. We describe when a Notified Body is required for CE
marking and what the main tasks of a Notified Body are in the conformity
assessment procedure chosen by the manufacturer. Finally, challenges and pitfalls
from the perspective of a Notified Body are summarized and discussed to ensure
that manufacturers and distributers of medical devices entering the European
market are optimally prepared for CE-marking approval.