Article 38 — Coordination of notified bodies (EU AI Act)

Article 38 of Regulation (EU) 2024/1689 — Coordination of notified bodies. Official text, practical interpretation, key obligations and compliance implications.

Official Text Summary

Article 38 of Regulation (EU) 2024/1689 establishes a mandatory coordination framework for notified bodies carrying out conformity assessments of high-risk AI systems under Title III, Chapter 5 of the Act. The article requires notified bodies to participate in, and actively contribute to, a coordination group operating under the oversight and facilitation of the European Commission.

The coordination mechanism serves a dual function. First, it ensures procedural consistency: notified bodies must align their assessment methodologies, interpretive approaches, and procedural standards so that equivalent high-risk AI systems receive equivalent scrutiny regardless of the Member State in which the assessment takes place. Second, it enables substantive learning: bodies must share relevant experience, emerging findings, and best practices arising from actual conformity assessments.

The Commission is tasked with facilitating the coordination group and may link it to existing sectoral coordination structures established under relevant Union harmonisation legislation — such as those operating in the medical devices, machinery, or civil aviation sectors — where AI systems are subject to sector-specific assessment requirements. Where European standardisation bodies such as CEN-CENELEC have developed harmonised standards relevant to AI, coordination under Article 38 must take those standards into account.

The article further provides that the Commission may adopt implementing acts to establish operational arrangements for the coordination group, including rules on information sharing, the frequency of coordination activities, and mechanisms for resolving divergences between bodies.

What This Means in Practice

For organisations developing or deploying high-risk AI systems, Article 38 has significant indirect compliance implications even though its direct obligations fall on notified bodies rather than on providers or deployers.

The most immediate practical effect is consistency of conformity assessment outcomes. Before the EU AI Act, divergent interpretations of technical requirements across Member State conformity assessment bodies were a recognised problem in the CE marking ecosystem. Article 38 is designed to prevent this from recurring for AI. Providers choosing a notified body for a conformity assessment can expect that the substantive standards applied will be comparable regardless of whether they engage an Austrian, Dutch, or German body.

For providers, this means documentation and technical files prepared for conformity assessment should be designed to meet a harmonised baseline rather than tailored to the idiosyncrasies of a particular body. It also means that information shared by a notified body within the coordination group — such as patterns of non-conformity or recurrent documentation gaps — may indirectly shape the scrutiny applied to future assessments across the whole ecosystem.

Deployers of high-risk AI systems in regulated sectors should note that sectoral coordination linkages under Article 38 mean that bodies assessing AI components embedded within medical devices, industrial machinery, or transport systems may be applying coordination outputs from both the AI Act group and the relevant sectoral group simultaneously. Compliance teams should monitor guidance and technical notes published by the Commission or the AI Office arising from coordination group activities.

Notified bodies themselves must budget for active participation in coordination, including staff time for meetings, working groups, and information-sharing obligations. Bodies that fail to engage meaningfully with coordination mechanisms risk adverse findings during the monitoring and peer review processes established elsewhere in Chapter 4.

Key Obligations

• Notified bodies must participate in the coordination group established or facilitated by the European Commission and contribute actively to its work.
• Bodies must share relevant experience, assessment findings, and methodological approaches with other participating notified bodies through the coordination structure.
• Bodies must align their conformity assessment practices with common approaches and interpretations developed through coordination, preventing divergent outcomes for comparable AI systems.
• The Commission must facilitate the coordination group and may link it to existing sectoral coordination bodies operating under other Union harmonisation legislation where AI systems fall within the scope of both regimes.
• The Commission may adopt implementing acts specifying organisational arrangements for the coordination group, including information-sharing protocols and procedures for resolving interpretive divergences between bodies.
• Notified bodies must take into account harmonised standards and relevant outputs from European standardisation activities when conducting coordinated assessments.

Relationship to Other Articles

Article 38 sits within Title III, Chapter 4, which collectively governs the designation, monitoring, and operation of notifying authorities and notified bodies. It must be read alongside Article 33, which establishes the substantive requirements a body must meet to be designated as a notified body, and Article 34, which covers the notification procedure itself. Article 35 addresses the operational obligations of notified bodies during assessments, while Article 36 covers subsidiaries and subcontracting. Article 37 establishes the monitoring and review of notified bodies by notifying authorities.

Beyond Chapter 4, Article 38 connects directly to the conformity assessment procedures in Chapter 5, particularly Articles 43 and 44, which specify when third-party notified body involvement is mandatory. The coordination work under Article 38 also intersects with the role of the AI Office established under Article 64 and the European Artificial Intelligence Board under Article 65, both of which have responsibilities for ensuring consistent application of the Regulation across Member States. Standardisation mandates issued under Article 40 are a primary input into the coordination group's technical work.

Compliance Timeline

The EU AI Act entered into force on 1 August 2024, following publication in the Official Journal of the European Union. Application of the Regulation is phased:

• February 2025 — Prohibitions on unacceptable-risk AI practices (Article 5) began applying.
• August 2025 — Obligations for general-purpose AI models (Title VIII) became applicable. Notified bodies may begin applying for designation from this date, triggering the initial activation of coordination obligations under Article 38.
• December 2026 — Conformity assessment obligations for high-risk AI systems listed in Annex I (products governed by existing Union harmonisation legislation) begin applying.
• August 2027 — Full application of high-risk AI system obligations under Annex III, making the notified body coordination framework under Article 38 fully operational across all covered use cases.

Organisations subject to third-party conformity assessments should engage with notified bodies well before the December 2026 and August 2027 deadlines, as coordination group outputs and harmonised assessment protocols are expected to solidify during 2025 and 2026. Monitoring Commission implementing acts relating to Article 38 coordination arrangements is recommended from mid-2025 onwards.