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EU AI Act Art. 43(4): new conformity assessment on substantial modification

A system already assessed undergoes a new conformity assessment on substantial modification; changes pre-determined in the technical documentation of a system that continues to learn are not substantial modifications

By Reviewed

From clause to evidenceThe chain from EU AI Act Art. 43(4) to its evidence record, in 6 steps; the text alternative lists them and the facts under the figure state each in full.Clause: EU AI Act (post-Omnibus), Art. 43(4)ClauseEU AI ActArt. 43Duty holder: ProviderDuty holderProviderApplies from: 2027-12-02 (Deferred)Applies from2027-12-02DeferredArtefact: Change-classification policy on merge; pre-determined change envelope as code; reassessment trigger in the registryArtefactChange-classificationpolicy on mergeLayers: Layer 01 Govern-as-Code and Layer 05 Assurance & Continuous ComplianceLayersLayer 01Layer 05Evidence record: Go/no-go decisionEvidence recordGo/no-godecisionSame topic elsewhere: no crosswalk topic files this clause yetAs of 2026-09-24 · illustrative, not a claim of conformity From clause to evidenceThe chain from EU AI Act Art. 43(4) to its evidence record, in 6 steps; the text alternative lists them and the facts under the figure state each in full.Clause: EU AI Act (post-Omnibus), Art. 43(4)ClauseEU AI Act · Art. 43Duty holder: ProviderDuty holderProviderApplies from: 2027-12-02 (Deferred)Applies from2027-12-02 · DeferredArtefact: Change-classification policy on merge; pre-determined change envelope as code; reassessment trigger in the registryArtefactChange-classification policy on…Layers: Layer 01 Govern-as-Code and Layer 05 Assurance & Continuous ComplianceLayersLayer 01Layer 05Evidence record: Go/no-go decisionEvidence recordGo/no-go decisionSame topic elsewhere: no crosswalk topicfiles this clause yetAs of 2026-09-24illustrative, not a claim of conformity
From clause to evidence Build the artefact, then file every output it produces as a record that names AIGE-OBL-EUAIA-ART43-4. Drawn from chapter 08.
Text alternative
  • Clause: EU AI Act, Art. 43.
  • Duty holder: Provider.
  • Applies from: 2027-12-02, Deferred.
  • Artefact: Change-classification policy on merge.
  • Layers: Layer 01, Layer 05.
  • Evidence record: Go/no-go decision.
  • Record schemas: Go/no-go decision .
  • No crosswalk topic files this clause yet.
When this obligation applies3 dates of AIGE-OBL-EUAIA-ART43-4 on a time axis, against its review date 2026-09-24.2024202620282030As of 2026-09-242027-12-02 · DeferredAnnex III2028-08-02 · High-risk(Annex I)Applies to Annex I embedded(product safety-component)systems2030-08-02 · Later stepDeadline for legacy high-risksystems intended for use bypublic authorities (Art.111(2))2027-12-02 · Deferred · Annex III2028-08-02 · High-risk (Annex I) · Applies to Annex I embedded (product safety-component) systems2030-08-02 · Later step · Deadline for legacy high-risk systems intended for use by public authorities (Art. 111(2))Source: Obligation register(chapter 08)
When this obligation applies3 dates of AIGE-OBL-EUAIA-ART43-4 on a time axis, against its review date 2026-09-24.2027-12-02 · DeferredAnnex III2028-08-02 · High-risk (Annex I)Applies to Annex I embedded(product safety-component)systems2030-08-02 · Later stepDeadline for legacy high-risksystems intended for use by publicauthorities (Art. 111(2))2024202620282030As of 2026-09-242027-12-02 · Deferred · Annex III2028-08-02 · High-risk (Annex I) · Applies to Annex I embedded (product safety-component) systems2030-08-02 · Later step · Deadline for legacy high-risk systems intended for use by public authorities (Art. 111(2))Source: Obligation register (chapter 08)
When this obligation applies The first date in the row's status, then each later step: filled once its date has passed, outlined while it is still ahead of the review date.
Data table: the dates
Dates of AIGE-OBL-EUAIA-ART43-4
DateStepDetail
2027-12-02DeferredAnnex III
2028-08-02High-risk (Annex I)Applies to Annex I embedded (product safety-component) systems
2030-08-02Later stepDeadline for legacy high-risk systems intended for use by public authorities (Art. 111(2))
Id
AIGE-OBL-EUAIA-ART43-4
Instrument
EU AI Act (post-Omnibus) law
Compared side by side
ISO 42001 vs EU AI Act · NIST AI RMF vs EU AI Act
Clause
Art. 43(4)
Duty holder
Provider
Authority
National MSA
Applies from
Deferred · Annex III
Later dates
  • Applies to Annex I embedded (product safety-component) systems
  • Deadline for legacy high-risk systems intended for use by public authorities (Art. 111(2))
System class
High-risk (Annex III) · High-risk (Annex I)

The artefact that evidences it

Change-classification policy on merge; pre-determined change envelope as code; reassessment trigger in the registry.

Patterns that build it

No pattern in the catalogue names this clause on its "Maps to" line yet; the artefact above is the engineering answer.

Source

Chapter 08, section EU AI Act, post-Omnibus, checked against its sources on the review date above.

Machine-readable

Cite this obligation

García Aibar, J. (2026). EU AI Act Art. 43(4): new conformity assessment on substantial modification (AIGE-OBL-EUAIA-ART43-4). In AI Governance Engineering: The Thesis & Body of Knowledge (v0.5.0). https://doi.org/10.5281/zenodo.22956197. https://aigovernanceengineer.com/obligations/aige-obl-euaia-art43-4. CC BY 4.0

BibTeX

@misc{aige2026obligation,
  author       = {Jorge García Aibar},
  title        = {{EU AI Act Art. 43(4): new conformity assessment on substantial modification (AIGE-OBL-EUAIA-ART43-4)}},
  howpublished = {In AI Governance Engineering: The Thesis \& Body of Knowledge},
  year         = {2026},
  version      = {0.5.0},
  doi          = {10.5281/zenodo.22956197},
  url          = {https://aigovernanceengineer.com/obligations/aige-obl-euaia-art43-4},
  note         = {Version 0.5.0}
}