What is A Notified Body?

Notified Body Definition

A notified body is an organization that has been designated by an EU member state to assess the conformity of medical devices against the relevant EU regulations (e.g., MDR 2017/745, IVDR 2017/746). Assessments involve review of manufacturer’s quality system and review of technical documentation that supports safety and performance claims of the device. A database of Notified Bodies for all relevant EU legislation is housed under NANDO (New Approach Notified and Designated Organizations).

DEKRA Certification Mark
TUV Rheinland Certification Mark
GMED Mark
CE Certification Mark

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