Article 106 — Amendments to Directive (EU) 2016/797 (EU AI Act)

Article 106 of Regulation (EU) 2024/1689 — Amendments to Directive (EU) 2016/797. Official text, practical interpretation, key obligations and compliance implications.

Official Text Summary

Article 106 of Regulation (EU) 2024/1689 (the EU AI Act) amends Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union. The amendment inserts AI Act-aligned references and provisions into the railway interoperability framework, ensuring that the two legal instruments operate coherently where AI systems are deployed in the railway sector.

The core purpose of Article 106 is legislative alignment: Directive 2016/797 governs the conditions under which rail subsystems and interoperability constituents may be placed in service across the EU, including safety assessments and the role of notified bodies. Where AI systems form part of such rail subsystems or interoperability constituents — particularly in safety-critical functions such as train control, signalling, or automated driving — the amendment ensures that the conformity assessment and supervisory obligations introduced by the AI Act are integrated into the existing railway regulatory structure rather than operating in parallel without coordination.

Article 106 belongs to Title XIII (Final Provisions), which contains a series of consequential amendments to sectoral EU legislation that must be updated to reflect the AI Act's new obligations. It does not stand alone as a substantive compliance chapter but rather ensures that the railway sector's pre-existing legal framework is brought into coherent alignment with the horizontal AI regulatory architecture established by Regulation (EU) 2024/1689.

What This Means in Practice

For organisations operating in the railway sector, Article 106 has two practical consequences that compliance teams must account for simultaneously.

First, any AI system integrated into a railway subsystem or interoperability constituent already subject to Directive 2016/797 must be assessed against both the railway interoperability requirements and, where applicable, the EU AI Act's high-risk AI system requirements. AI systems involved in train control, automatic train operation, infrastructure monitoring, or safety-critical maintenance functions are strong candidates for classification as high-risk AI systems under Annex I, Section 3 of the AI Act (AI in transport). This means conformity assessment procedures under both regimes apply, and compliance teams must map how the two assessments interact, which notified body or conformity assessment body is competent, and how technical documentation requirements can be harmonised.

Second, national safety authorities responsible for supervising compliance with Directive 2016/797 must coordinate with the national competent authorities designated under Article 70 of the EU AI Act. Article 106 creates the legal basis for this coordination by embedding AI Act references into the railway directive, but organisations should not wait for national authorities to establish coordination protocols before acting. Proactive engagement with both the railway safety authority and the AI market surveillance authority is advisable.

Practically, railway undertakings and infrastructure managers should audit their AI deployments, identify which systems fall within the scope of both Directive 2016/797 and the EU AI Act, and initiate dual-compliance documentation processes as early as possible.

Key Obligations

• Dual-regime conformity assessment: AI systems forming part of railway subsystems or interoperability constituents must satisfy both the conformity assessment procedures under Directive 2016/797 and, where classified as high-risk, the requirements of Chapter III of the EU AI Act.
• Coordinated supervisory engagement: Operators must engage with both national railway safety authorities and AI Act market surveillance authorities where AI systems are deployed in safety-critical rail functions.
• Technical documentation alignment: Providers and deployers must ensure that technical documentation prepared under Article 11 of the EU AI Act and the technical files required under Directive 2016/797 are mutually consistent and cross-referencing.
• Notified body competence verification: Organisations must verify that conformity assessment bodies authorised under Directive 2016/797 have the competence and designation to assess AI-related components, or identify whether separate AI Act notified bodies must be involved.
• Continuous monitoring obligations: High-risk AI systems deployed in railway operations are subject to the post-market monitoring and incident reporting obligations of the EU AI Act (Articles 72–73), which must be integrated into existing railway safety management systems.
• Legislative watch: Because Article 106 amends Directive 2016/797 rather than creating standalone obligations, organisations must track implementing measures and guidance issued under that directive as it evolves post-amendment.

Relationship to Other Articles

Article 106 must be read alongside the substantive high-risk AI system provisions of the EU AI Act, particularly Articles 9 through 17 (risk management, data governance, technical documentation, transparency, human oversight, accuracy and robustness), and Article 43 (conformity assessment procedures for high-risk systems). Annex I, Section 3 of the AI Act, which lists AI systems in transport as a high-risk category, is the primary classification gateway for railway AI deployments affected by Article 106.

Within Title XIII, Article 106 sits alongside Articles 102 through 113, which collectively amend a range of sectoral EU directives and regulations to ensure coherence with the AI Act's horizontal framework. Article 97 (review and amendments to Annexes) and Article 98 (exercise of delegation) are relevant for understanding how the Annex I classification lists — and therefore the scope of Article 106's practical impact — may evolve over time. Article 70 (designation of national competent authorities) defines the supervisory architecture that Article 106 implicitly relies upon for enforcement coordination with railway safety bodies.

Compliance Timeline

Article 106 entered into force on 1 August 2024, the date Regulation (EU) 2024/1689 took effect, as published in the Official Journal of the European Union on 12 July 2024. However, its practical impact follows the phased application schedule of the broader EU AI Act:

• 2 February 2025 — Prohibited AI practices (Article 5) became applicable. Railway operators should have assessed by this date whether any AI deployment in the rail sector met a prohibition threshold.
• 2 August 2025 — GPAI model obligations and governance provisions became applicable. Railway AI systems using general-purpose AI models as components must comply from this date.
• 2 August 2026 — High-risk AI systems listed in Annex I (including safety components covered by existing Union harmonisation legislation such as Directive 2016/797) must comply with Chapter III obligations, with the exception of certain systems covered by the extended transition.
• 2 August 2027 — Final deadline for high-risk AI systems already placed on the market before 2 August 2026 to be brought into compliance where they have undergone significant modifications, and the latest deadline for most remaining high-risk transitional provisions.

Railway sector organisations should treat August 2026 as their primary hard compliance deadline for AI systems affected by Article 106's amendments, and should have conformity assessment processes well underway by the end of 2025.