Glossary
Updated
While many high-risk systems can undergo internal control assessments, certain systems (like remote biometric identification) require a third-party assessment by a Notified Body to verify the system's technical documentation and risk management systems. The Notified Body audits the provider's Quality Management System (QMS) before the CE mark can be legally applied.
Example
A startup building a facial recognition tool for an airport must hire a government-approved Notified Body to audit their algorithm before they are legally allowed to deploy it in the EU.