Notified Body
A Notified Body is an organisation designated by a national authority and notified by the EU Commission to carry out conformity assessment procedures for medical devices. It reviews technical documentation, conducts quality management system audits, and issues EU conformity certificates that are a prerequisite for CE marking. Under the EU MDR, Notified Bodies themselves are subject to strict designation and monitoring requirements.
Notified Bodies also review labelling and instructions for use as part of the certification process. A deficient or missing IFU translation can lead to audit findings and delay certification.
Frequently Asked Questions
Do Notified Bodies review translations of instructions for use?+
Yes, Notified Bodies may spot-check the quality and completeness of IFU translations during conformity assessment and audits. They verify whether all regulatory required content has been correctly transferred into the respective national language and whether terminology is consistent and technically accurate.