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Annexes — referenced by Article 6(1)Article Annex I

Annex I: Union Harmonisation Legislation — Product Law List

Applies from 2 Aug 20275 min readEUR-Lex verified Apr 2026

Annex I lists the Union harmonisation legislation (product-law directives and regulations) referenced by Article 6(1). AI systems that are safety components of products covered by this legislation — or that are themselves such products — are classified as high-risk when the product requires third-party conformity assessment. The list is divided into Section A (legislation listed in full) and Section B (other Union harmonisation legislation). Key sectors include machinery, toys, lifts, medical devices, in vitro diagnostics, vehicles, aviation, marine equipment, and more.

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Who does this apply to?

  • -Product manufacturers where AI is a safety component under Annex I legislation
  • -Providers of AI systems that are themselves regulated products (e.g. medical devices with AI)
  • -Notified bodies conducting integrated conformity assessments under Article 43(3)
  • -Regulatory teams mapping dual compliance (product law + AI Act)

Scenarios

A medical device with an AI diagnostic algorithm is regulated under the Medical Devices Regulation (MDR) 2017/745, which is listed in Annex I Section A.

Article 6(1) path: the AI component is high-risk if MDR conformity includes a notified body assessment. One integrated assessment covers both MDR and AI Act requirements.
Ref. Annex I + Art. 6(1) + Art. 43(3)

A toy with an AI-powered interactive feature falls under Directive 2009/48/EC (Toy Safety), listed in Annex I Section A.

If the AI component is a safety component and the toy requires third-party conformity assessment, Article 6(1) classifies it as high-risk AI.
Ref. Annex I + Art. 6(1)

A company builds an AI scheduling tool for a factory but the tool does not interact with machinery safety functions.

Even though the factory uses machinery under the Machinery Regulation, the AI tool is not a safety component — Annex I does not apply. Check Annex III for alternative high-risk classification.
Ref. Art. 6(1) — not triggered

What Annex I covers (plain terms)

Annex I lists the EU product-safety laws that interact with the AI Act. The key concept:

  • If an AI system is a safety component of a product covered by Annex I legislation
  • AND the product must undergo third-party conformity assessment under that legislation
  • THEN the AI system is classified as high-risk under Article 6(1)

This creates the product-law path to high-risk classification — distinct from the Annex III use-case path under Article 6(2).

Key legislation in Annex I (headline view)

Section A includes (among others): - Machinery Regulation (EU) 2023/1230 - Toy Safety Directive 2009/48/EC - Recreational Craft Directive 2013/53/EU - Lifts Directive 2014/33/EU - PPE Regulation (EU) 2016/425 - Medical Devices Regulation (MDR) (EU) 2017/745 - In Vitro Diagnostics Regulation (IVDR) (EU) 2017/746 - Civil Aviation Safety Regulation (EU) 2018/1139 - Motor Vehicles — various type-approval regulations - Rail interoperability directives - Marine Equipment Directive 2014/90/EU

Section B references other Union harmonisation legislation.

Always check the complete list on EUR-Lex Annex I.

Annex I vs Annex III — two paths to high-risk

| | Annex I (Article 6(1)) | Annex III (Article 6(2)) | |---|---|---| | Trigger | AI as safety component of listed product law | AI for listed use cases (biometrics, employment, etc.) | | Conformity | Integrated with sectoral assessment | Standalone AI Act assessment (Annex VI/VII) | | Application date | 2 August 2027 | 2 August 2026 | | Notified body | As required by sectoral law | Only for biometric ID (Annex III pt 1) |

A system can fall under both paths simultaneously (e.g. a medical AI device also used for Annex III biometric purposes).

Recitals (preamble) on EUR-Lex

The recitals in the same consolidated AI Act on EUR-Lex contextualise the product-safety alignment, integrated conformity, and the one-year delay for Annex I systems (2027 vs 2026). Use the official preamble on EUR-Lex.

Compliance checklist

  • Identify whether your product falls under any Annex I legislation (Section A or B).
  • Assess whether the AI component is a 'safety component' of the product.
  • Check whether the product requires third-party conformity assessment under the sectoral law.
  • If all three conditions met: classify as high-risk under Article 6(1) — integrated assessment under Article 43(3).
  • Map dual compliance requirements between the sectoral law and AI Act Chapter III.
  • Track the August 2, 2027 application date for Annex I systems.
  • If your AI also falls under Annex III, apply the earlier date (August 2, 2026) and the stricter regime.
Read the official text on EUR-Lex

Check if your product triggers the Annex I path—free assessment.

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Related annexes

  • Annex III — High-risk use cases (the alternative classification path)
  • Annex IV — Technical documentation for high-risk systems

Frequently asked questions

Does every AI in a medical device trigger Annex I?

Only if the AI is a safety component (or the device itself) AND the device requires notified body assessment under MDR. Class I devices with self-declaration may not trigger Article 6(1) — but check Annex III for alternative classification.

Why do Annex I systems have an extra year (2027)?

The one-year delay recognises that dual-regulated products need additional time to integrate AI Act requirements into existing sectoral conformity processes.

Can the Commission update Annex I?

Yes, via delegated acts under Article 7, to reflect new or amended Union harmonisation legislation.