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

The Cost
of
Mistakes

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.