Article 38: Coordination of Notified Bodies
Article 38 requires the Commission to ensure appropriate coordination and cooperation between notified bodies through a sectoral group of notified bodies. All notified bodies under the AI Act must participate in this group — directly or through designated representatives. The group's purpose is to ensure harmonised application of conformity-assessment procedures, facilitate the exchange of best practices, and address any issues arising from the application of conformity assessment under the AI Act.
Who does this apply to?
- -Notified bodies that must participate in the sectoral coordination group, directly or via designated representatives
- -The European Commission, which facilitates and ensures the coordination between notified bodies
- -Providers of high-risk AI systems who benefit from harmonised assessment approaches across the single market
Scenarios
Two notified bodies in different Member States interpret the technical documentation requirements under Article 43 differently — one requires full source-code review, the other accepts a functional-equivalence analysis. The discrepancy creates competitive distortion.
A notified body encounters a novel AI architecture (e.g., a neuro-symbolic system) for which no established assessment methodology exists. It raises the issue in the sectoral coordination group.
What Article 38 requires
Article 38 establishes three core elements:
1. Commission facilitation — The Commission must ensure that appropriate coordination and cooperation between notified bodies takes place through a sectoral group.
2. Mandatory participation — Notified bodies must participate in the group directly or through designated representatives. This is not optional — it is an operational obligation.
3. Harmonisation mandate — The group must work toward: - Harmonised application of conformity-assessment procedures under the AI Act - Exchange of best practices among notified bodies - Resolution of issues arising from the practical application of conformity assessment
Why harmonisation matters
Without coordination, notified bodies in different Member States could develop divergent assessment standards, leading to:
- Forum shopping — Providers selecting the body with the easiest assessment
- Uneven safety levels — Higher-risk systems passing assessment in one Member State but failing in another
- Market fragmentation — Undermining the single market objective
The sectoral group under Article 38 is the AI Act's primary mechanism for preventing these outcomes. It mirrors the coordination groups that already exist under other Union product-safety legislation (e.g., the Medical Device Regulation).
How Article 38 connects to the broader framework
- Article 30 — Requirements for notified bodies; the coordination group helps ensure all bodies maintain consistent standards.
- Article 36 — Operational obligations that the group's harmonisation work helps interpret consistently.
- Article 43 — The conformity-assessment procedures whose harmonised application is a core group objective.
- Article 113 — Application dates.
Compliance checklist
- If your organisation is a notified body, confirm that you have designated a representative or directly participate in the sectoral group.
- Notified bodies should implement guidance and best practices issued by the coordination group into their assessment procedures.
- Providers can ask their notified body whether it participates in the coordination group and applies its harmonised methodologies.
- Track publications or position papers from the sectoral group that may affect how your conformity assessment is conducted.
- Notifying authorities should verify that notified bodies under their oversight are fulfilling their participation obligation.
Understand the conformity-assessment landscape — start the free assessment.
Start Free AssessmentRelated Articles
Frequently asked questions
Is the sectoral group a new body created by the AI Act?
The concept of sectoral coordination groups for notified bodies already exists under other Union product-safety legislation. Article 38 extends this model to the AI Act, with the Commission ensuring the group is established and functions effectively.
Can a notified body opt out of the coordination group?
No. Participation is mandatory — notified bodies must participate directly or through designated representatives. Failure to participate could be considered a breach of operational obligations.
How does this benefit providers?
Providers benefit from more predictable and consistent conformity-assessment outcomes across Member States, reducing the risk of conflicting interpretations and enabling smoother cross-border market access.