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AnnexesArticle Annex IX

Annex IX: Union Legislation Listed Under Article 43(1) Third Subparagraph

Applies from 2 Aug 20264 min readEUR-Lex verified Apr 2026

Annex IX lists the Union harmonisation legislation for which the third-party conformity assessment by a notified body under Annex VII must be carried out in conjunction with the existing product-safety conformity assessment. When a high-risk AI system is a safety component of a product already regulated by one of the Annex IX acts, the notified body assessment under the AI Act is integrated into the existing third-party assessment. This avoids duplication: one notified body covers both the product-safety and AI Act requirements. The list overlaps with but is not identical to Annex I.

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Who does this apply to?

  • -Providers of high-risk AI systems that are safety components of products under Annex IX legislation
  • -Notified bodies carrying out combined assessments
  • -Product compliance teams coordinating AI Act and sectoral conformity

Scenarios

An AI-powered medical device component requires Annex VII assessment under the AI Act. The device is also regulated under MDR 2017/745.

Because MDR is listed in Annex IX, the notified body carries out the AI Act Annex VII assessment integrated with the MDR conformity assessment.
Ref. Annex IX + Art. 43

A standalone AI credit-scoring system is high-risk under Annex III but not part of any Annex IX-listed product.

Annex IX does not apply — the provider follows Article 43's normal decision tree (typically Annex VI internal control for non-biometric Annex III systems).
Ref. Art. 43

What Annex IX contains

Annex IX lists Union harmonisation legislation where third-party conformity assessment is already required for the product. When the AI system is a safety component of such a product, the AI Act Annex VII assessment is conducted as part of the existing product assessment by the same or a cooperating notified body.

Key legislation in the list includes (confirm the full list on EUR-Lex Annex IX):

  • Regulation (EU) 2017/745 — Medical Devices Regulation (MDR)
  • Regulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices Regulation (IVDR)
  • Other product-safety legislation requiring third-party assessment

Annex IX vs Annex I

| Feature | Annex I | Annex IX | |---|---|---| | Purpose | Lists legislation that triggers Article 6(1) high-risk classification | Lists legislation where notified body assessment must be integrated | | Focus | Classification — *is* the system high-risk? | Assessment route — *how* is conformity assessed? | | Scope | Broader list of product-safety laws | Subset where third-party assessment already required |

A product may appear in Annex I (triggering high-risk classification) without being in Annex IX (if only self-certification is required under the sectoral law).

How Annex IX connects to the rest of the Act

  • Article 43(1) — References Annex IX in the third subparagraph for integrated assessment.
  • Annex VII — The notified body assessment procedure integrated with the product-safety assessment.
  • Annex I — Broader product-legislation list for classification.
  • Article 44 — Certificate lifecycle for integrated assessments.

Compliance checklist

  • Check if your product falls under Annex IX legislation requiring third-party assessment.
  • If yes: coordinate with your product-safety notified body to integrate AI Act Annex VII assessment.
  • If no: follow Article 43's normal decision tree for assessment route.
  • Document which Annex IX legislation applies and the integrated assessment approach.
  • Verify the full Annex IX list on EUR-Lex — it may be updated by delegated acts.
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Related annexes

  • Annex I — Union harmonisation legislation (classification)
  • Annex VII — Notified body conformity assessment

Frequently asked questions

Does Annex IX create new high-risk classifications?

No. Annex IX determines the assessment route, not the classification. Classification comes from Article 6 and Annex I/III.

Can I use a different notified body for the AI Act and the product-safety assessment?

The integrated approach in Annex IX aims for one combined assessment. Verify the exact procedural rules on EUR-Lex, as cooperation between notified bodies may be possible.

Does Annex IX create additional high-risk AI classifications?

No. Annex IX lists existing Union legislation whose conformity assessment procedures are extended to cover AI Act requirements when the AI system is a safety component of a product under that legislation. It does not create new high-risk categories but ensures the AI Act requirements are integrated into existing product-law assessments.