Driver monitoring and assistance: which AI Act duties apply?
In-vehicle AI often falls under the product legislation in Annex I of the AI Act. Whether the high-risk rules apply depends on that sectoral type-approval law — not on Annex III.
Short answer: AI functions for driver monitoring and driving assistance may fall under the AI Act's high-risk rules, but not via the standalone list in Annex III. They run through the Annex I route: AI as a safety component of a product that already falls under sectoral product legislation and type-approval. Whether and when the high-risk duties apply is therefore co-determined by that vehicle legislation.
Two routes to "high-risk"
The AI Act (Regulation (EU) 2024/1689) provides two ways for an AI system to qualify as high-risk. The first is Annex III, a standalone list of use cases. The second, in Article 6(1) and Annex I, applies to AI systems intended to be used as a safety component of a product covered by the Union harmonisation legislation listed there, or that are themselves such a product — provided the product requires third-party conformity assessment.
For vehicles, Annex I refers to the sectoral type-approval legislation. Driver monitoring and driving assistance embedded as a safety component in a vehicle can therefore, in principle, fall under the Annex I high-risk route. The exact scope follows from the interplay between the AI Act and the relevant sectoral legislation; consult the primary sources for this.
What this means in practice
If a system falls under the high-risk route, the requirements of Chapter III of the Regulation apply: risk management, data governance, technical documentation, event logging, transparency towards users, human oversight and appropriate accuracy, robustness and cybersecurity. For products with an existing conformity assessment, the Regulation aims to integrate these requirements as far as possible into the existing sectoral procedures, to limit duplicate assessment.
Timeline and points of attention
The dates of application differ per route. For high-risk systems covered by the Annex I product legislation, the Regulation sets a later date of application than for the Annex III systems. Because these dates are subject to ongoing amendment, it is advisable to verify the current state via the primary source and the Commission policy page before committing to a date.
Note that not every in-car AI is high-risk: functions that do not constitute a safety component, or products without a mandatory third-party assessment, may fall outside the high-risk category. A concrete classification always requires assessment against the Regulation's text and the sectoral legislation.
Read more: AI Act: timeline of obligations. Take the scan.
Sources
- https://eur-lex.europa.eu/eli/reg/2024/1689/oj
Regulation (EU) 2024/1689 (AI Act), authentic text in the Official Journal; Article 6 and Annex I set out the high-risk route via product legislation. - https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai
European Commission policy page on the AI Act, with the state of implementation and delegated acts.
Read next
AI as a medical device: the dual conformity (MDR + AI Act)
If your AI is a medical device, it must meet both the MDR (clinical evaluation, CE) and the AI Act (high-risk requirements). The regulations are meant to run together through a single conformity assessment and one notified body — not two separate tracks.
AI in healthcare: the AI Act and the Medical Device Regulation (MDR)
Medical AI often falls under two regimes at once: as a medical device under the MDR (CE marking) and as high-risk AI under the AI Act (Annex I). The regulations align the conformity assessment as far as possible. Health data is also special-category personal data under the GDPR.
Which AI systems are high-risk? The Commission's draft Article 6 guidelines
On 19 May 2026 the Commission published draft guidelines on which AI systems are high-risk under Article 6: the two routes (Annex I and Annex III), the Article 6(3) filter and practical examples. Non-binding; the targeted consultation was extended to 23 July 2026, final text expected later in 2026.