Article 104 — Amendments to Regulation (EU) No 168/2013 (EU AI Act)

Article 104 of Regulation (EU) 2024/1689 — Amendments to Regulation (EU) No 168/2013. Official text, practical interpretation, key obligations and compliance implications.

Official Text Summary

Article 104 of Regulation (EU) 2024/1689 (the EU AI Act) forms part of Title XIII, which contains the final provisions governing the Act's integration with the broader EU regulatory landscape. Specifically, Article 104 introduces targeted amendments to Regulation (EU) No 168/2013 of the European Parliament and of the Council on the approval and market surveillance of two- or three-wheel vehicles and quadricycles — collectively known as L-category vehicles.

The amendment mechanism reflects the EU legislature's standard approach when enacting horizontal legislation: existing sectoral regulations must be updated to remain coherent with new cross-cutting rules. Regulation (EU) No 168/2013 established a comprehensive type-approval framework covering safety and environmental requirements for L-category vehicles. Where such vehicles incorporate AI systems — for example, advanced rider-assistance systems, automated braking, or adaptive cruise control functions — those AI components may fall within the scope of the EU AI Act and could qualify as high-risk AI systems under Annex I, Section 2 (AI systems used as safety components in products covered by Union harmonisation legislation).

Article 104 ensures that references, definitions, and procedures within Regulation (EU) No 168/2013 are aligned with the terminology and requirements introduced by the EU AI Act, preventing regulatory gaps or conflicts between the two instruments and preserving legal certainty for manufacturers and market surveillance authorities operating in the L-category vehicle sector.

What This Means in Practice

For manufacturers, importers, distributors, and authorised representatives of L-category vehicles, Article 104 has practical consequences wherever AI systems are integrated into those vehicles.

The most immediate effect is that any AI system functioning as a safety component in a moped, motorcycle, motor tricycle, or light quadricycle must be evaluated against the EU AI Act's high-risk classification criteria. If classified as high-risk, the AI system must comply with Chapter III requirements — including conformity assessment, technical documentation, post-market monitoring, transparency obligations, and registration in the EU database — in addition to the existing obligations under Regulation (EU) No 168/2013.

For type-approval purposes, national type-approval authorities and technical services involved in assessing L-category vehicles will need to verify AI Act compliance as part of their broader review. This may require updated assessment protocols and additional competences among designated technical services.

Practically, a manufacturer developing an AI-driven traction control or collision avoidance system for a motorcycle should:

• Determine whether the AI system qualifies as a safety component under Annex I of the EU AI Act.
• If high-risk, prepare a conformity assessment dossier meeting EU AI Act requirements before placing the vehicle on the market.
• Ensure that the technical documentation required by Regulation (EU) No 168/2013 is consistent with and references the AI Act documentation where applicable.
• Implement quality management systems covering the AI lifecycle, including post-market monitoring and incident reporting.

Market surveillance authorities responsible for L-category vehicles will likewise need to coordinate with authorities designated under the EU AI Act to avoid duplicative or conflicting oversight actions.

Key Obligations

• Regulatory alignment: Legal and compliance teams must ensure that all internal procedures for L-category vehicle development reflect the amendments introduced by Article 104, keeping type-approval documentation consistent with EU AI Act requirements where AI systems are present.
• High-risk classification review: Manufacturers must assess whether AI systems integrated into L-category vehicles qualify as high-risk AI systems under Annex I of the EU AI Act, triggering the full conformity assessment obligations of Chapter III.
• Updated technical documentation: Where AI systems are involved, technical documentation submitted for type-approval under Regulation (EU) No 168/2013 must be coherent with the technical documentation requirements set out in Article 11 and Annex IV of the EU AI Act.
• Conformity assessment procedures: High-risk AI systems in L-category vehicles must undergo conformity assessment as required by Article 43 of the EU AI Act prior to market placement, alongside the existing type-approval procedure.
• Market surveillance coordination: Authorities with competence under Regulation (EU) No 168/2013 and those designated under the EU AI Act must coordinate their market surveillance activities to ensure effective and non-duplicative oversight.
• Post-market monitoring: Manufacturers of L-category vehicles incorporating high-risk AI systems must establish post-market monitoring plans and report serious incidents in accordance with Articles 72 and 73 of the EU AI Act.

Relationship to Other Articles

Article 104 does not operate in isolation. It must be read alongside the definitional provisions of Article 3, which defines key concepts including AI system, safety component, and high-risk AI system. The high-risk classification criteria in Article 6 and Annex I are directly relevant: Section 2 of Annex I lists AI systems used as safety components in products covered by Union harmonisation legislation, which explicitly encompasses vehicle regulations.

The obligations triggered by a high-risk classification — technical documentation (Article 11 and Annex IV), conformity assessment (Article 43), quality management systems (Article 17), post-market monitoring (Article 72), and incident reporting (Article 73) — all apply to AI systems in L-category vehicles once the classification threshold is met.

Article 104 should also be read alongside the other amendment articles in Title XIII — including Articles 103, 105, and 106 — which collectively update several sectoral Union harmonisation regulations to ensure horizontal coherence with the EU AI Act.

Compliance Timeline

Article 104 entered into force on 1 August 2024, twenty days after the publication of Regulation (EU) 2024/1689 in the Official Journal of the European Union on 12 July 2024.

The phased application schedule of the EU AI Act determines when the substantive obligations relevant to Article 104 become enforceable:

• 1 August 2024 — Entry into force; the amendments to Regulation (EU) No 168/2013 take legal effect.
• 2 February 2025 — Provisions on prohibited AI practices (Article 5) become applicable; not directly relevant to Article 104 but marks the beginning of substantive enforcement.
• 2 August 2025 — GPAI model obligations and governance provisions apply; manufacturers should have reviewed their AI system classifications by this date.
• 2 December 2026 — High-risk AI systems listed in Annex I (which includes safety components in vehicles) must fully comply with all EU AI Act obligations. This is the critical compliance deadline for AI systems in L-category vehicles subject to Regulation (EU) No 168/2013.
• 2 August 2027 — Extended deadline for certain high-risk AI systems already placed on the market before August 2024, subject to conditions in Article 111.

Manufacturers of L-category vehicles incorporating AI systems should use the period up to December 2026 to complete classification assessments, conformity procedures, and documentation alignment across both regulatory frameworks.