Notified Bodies for AI Systems

Legal Framework

The role and designation of Notified Bodies for AI systems are governed by Articles 31-39 of the AI Act, which establish the framework for third-party conformity assessment of high-risk AI systems. The legal text mandates that Notified Bodies, designated by national authorities, are responsible for assessing the conformity of high-risk AI systems with the Act's requirements before they are placed on the market or put into service. Their core tasks include auditing the quality management systems of providers and reviewing the technical documentation of specific AI systems, culminating in the issuance of an EU technical documentation assessment certificate.

Practical Application

Recitals 125 and 179 of the AI Act provide critical context for interpretation. Recital 125 underscores that the involvement of Notified Bodies is essential due to the complexity and inherent risks of high-risk AI systems, establishing a pre-market conformity assessment modeled on existing product safety frameworks but adapted for AI-specific risks. The operational requirements for Notified Bodies are stringent; they must demonstrate independence, competence, and integrity. They are accredited against harmonised standards and must undergo ongoing monitoring by their designating national authority. A key practical implication is the phased application timeline highlighted in Recital 179: while prohibitions apply from February 2025, the conformity assessment procedures involving Notified Bodies for high-risk AI systems will fully apply from August 2026, giving providers and bodies time to prepare.

Key Considerations

• Provider Preparation for Assessment: Providers of high-risk AI systems must engage with a Notified Body early to understand the specific evidence required for conformity assessment, particularly for their technical documentation and quality management system.
• Selecting a Notified Body: Providers must verify that a Notified Body is designated for the specific category of their high-risk AI system under the AI Act and holds valid accreditation, as designations are not universal across all AI use-cases.
• Ongoing Compliance: Certification by a Notified Body is not a one-time event. Providers must maintain their quality system and ensure continued conformity, as Notified Bodies will conduct ongoing surveillance and may withdraw certificates in case of non-compliance.