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EU AI Act Declaration of Conformity Template

Art. 47 and Annex V declaration for a high-risk AI system: conformity route, evidence before signing, eight Annex V items, CE marking

IA & Apprentissage automatiqueStandardEU AI Act Art. 47, Annex Vactdeclarationconformity

Mode d'emploi: Use it when a provider has completed the conformity assessment of a high-risk AI system and must sign the EU declaration of conformity. Fill the conformity route and the evidence table first and sign only when every row is complete. The main pitfall is signing under internal control when a notified body is required, or not updating the declaration after a substantial modification.

Aperçu

EU Declaration of Conformity: [High-risk AI system name] [version]

EU declaration of conformity for a high-risk AI system under Article 47 and Annex V of the EU Artificial Intelligence Act (Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744). Part A prepares and controls the declaration; Part B is the declaration itself, with the eight Annex V items in order. Under the amended Article 113 the high-risk requirements apply from 2 December 2027 for Annex III systems and from 2 August 2028 for systems covered by Annex I legislation; check the consolidated text for the dates that apply to you. Replace every [bracketed] value and every row marked Example. This is a documentation format, not legal advice.

Document control

FieldValue
Document ID[DoC-001]
AI system and version[Name] [version]
Provider[Legal name]
Declaration version[1.0]
Status[Draft / Signed / Superseded / Withdrawn]
Owner[@regulatory-lead]
Reviewers[@legal], [@quality-manager], [@product-owner]
Signatory[Name, function]
Language versions[EN, DE, FR, other]
Machine-readable format[PDF/A with embedded metadata / XML / other]
Retention until[Date 10 years after placing on the market or putting into service]
Last updatedYYYY-MM-DD

Approvals

RoleNameDecisionDate
Quality manager[@name][Evidence complete / Not complete]YYYY-MM-DD
Legal[@name][Approve / Reject]YYYY-MM-DD
Signatory[@name][Signed]YYYY-MM-DD

Revision history

VersionDateAuthorChange summary
0.1YYYY-MM-DD[@name]First draft
1.0YYYY-MM-DD[@name]Example: Signed for release 3.2
1.1YYYY-MM-DD[@name]Example: Provider address changed; no change to conformity

1. Context and conformity route

QuestionAnswer
High-risk basis[Article 6(1) and Annex I act / Article 6(2) and Annex III point] Example: Annex III, point 4(a): recruitment and selection
Conformity assessment procedureExample: Internal control, Annex VI
Notified body involved[Name and number / Not applicable]
Other Union harmonisation legislation requiring a declaration[List / None]
Personal data processed?[Yes / No]
Harmonised standards or common specifications applied[References, see item 6]

2. Evidence before signature

IDRequirementArticleEvidenceStatus
DOC-EV-001 (Example)Risk management systemArt. 9Risk management file RMF-3.2Complete
DOC-EV-002 (Example)Data and data governanceArt. 10Data governance report DG-3.2Complete
DOC-EV-003 (Example)Technical documentationArt. 11, Annex IVai-data/ai-act-technical-documentation file TD-3.2Complete
DOC-EV-004 (Example)Record-keeping (logs)Art. 12Logging specification LOG-2Complete
DOC-EV-005 (Example)Transparency and instructions for useArt. 13Instructions for use IFU-3.2Complete
DOC-EV-006 (Example)Human oversightArt. 14ai-data/human-oversight-design HOD-3Complete
DOC-EV-007 (Example)Accuracy, robustness and cybersecurityArt. 15Validation report VAL-3.2; penetration test PT-12Complete
DOC-EV-008 (Example)Quality management systemArt. 17QMS manual QM-4Complete
DOC-EV-009 (Example)Conformity assessment recordArt. 43Internal control report ICR-3.2Complete

Signature rule: every row must show Complete. [Record who checked and when.]

3. Declaration (Annex V items)

EU DECLARATION OF CONFORMITY

Declaration number: [DoC-001, version 1.0]

3.1 Item 1: AI system identification

FieldValue
Name[AI system name] Example: VH-Screen
Type[Type] Example: Candidate shortlisting software, decision support
Version and unique reference[Version, build ID, other reference allowing identification and traceability] Example: 3.2.0, build 3.2.0+4471

3.2 Item 2: Provider

FieldValue
Provider name and address[Legal name, address] Example: Vennamire Hiring Systems GmbH, a fictional provider, [address]
Authorised representative (where applicable)[Name and address / Not applicable]

3.3 Item 3: Sole responsibility

This declaration of conformity is issued under the sole responsibility of the provider named in item 2.

3.4 Item 4: Statement of conformity

The AI system identified in item 1 is in conformity with Regulation (EU) 2024/1689, as amended, [and with the following other Union law that provides for an EU declaration of conformity: list acts, or delete this phrase].

3.5 Item 5: Data protection

[Where the system processes personal data:] The AI system complies with Regulation (EU) 2016/679 [and, where relevant, Regulation (EU) 2018/1725 and Directive (EU) 2016/680]. [Where it does not process personal data, state so or delete this item according to your legal advice.]

3.6 Item 6: Harmonised standards and common specifications

ReferenceTitleParts applied
[Standard reference and date as published in the Official Journal][Title][Clauses or full]
Example: EN 18286:2026 (reference cited by Commission Implementing Decision (EU) 2026/2274, October 2026; check the OJ)Artificial intelligence, Quality management system for EU AI Act regulatory purposes[Clauses or full]
[Common specification reference][Title][Clauses or full]

[If none were applied, state that conformity was shown by other means described in the technical documentation.]

3.7 Item 7: Notified body (where applicable)

FieldValue
Notified body name and number[Name, four-digit number / Not applicable]
Conformity assessment procedure[Annex VII / procedure under the Annex I sectoral legislation]
Certificate[Certificate number and date / Not applicable]

3.8 Item 8: Place, date and signature

FieldValue
Place and date of issue[City], YYYY-MM-DD
Name and function of signatory[Name, function]
Signed for and on behalf of[Provider legal name]
Signature[Physical or electronic signature]

4. After signature

Step or triggerActionOwner
CE marking (Art. 48)Affix visibly, or digitally for digital-only systems[@product-owner]
EU database registration (Art. 49)Register before placing on the market where required[@regulatory-lead]
Copy on requestProvide to national competent authorities on request[@regulatory-lead]
Change of provider detailsUpdate declaration version[@legal]
Substantial modificationNew conformity assessment and new declaration[@quality-manager]
New or revised harmonised standard appliedUpdate item 6[@quality-manager]

5. References

  • Regulation (EU) 2024/1689 (Artificial Intelligence Act), Articles 16, 43, 47, 48 and 49 and Annexes V, VI and VII, as amended by Regulation (EU) 2026/1744; consolidated text on EUR-Lex, https://eur-lex.europa.eu/eli/reg/2024/1689/oj
  • Lists of harmonised standards for the AI Act published by the European Commission (check the Official Journal references).
  • Related templates: technical documentation (ai-data/ai-act-technical-documentation), human oversight design (ai-data/human-oversight-design), post-market monitoring (ai-data/ai-post-market-monitoring), fundamental rights impact assessment (ai-data/ai-act-fria), quality management system (ai-data/ai-act-quality-management-system), instructions for use (ai-data/ai-act-instructions-for-use).

Standard and licence note

Based on Article 47 and Annex V of Regulation (EU) 2024/1689 (the Artificial Intelligence Act) as amended by Regulation (EU) 2026/1744. The Annex V items are summarised in original wording; EU legislative texts are free to reuse, and no text of the Regulation is reproduced beyond short item names. The provider, system and references are fictional examples. Check the consolidated text on EUR-Lex and current Commission guidance before signing. This is a documentation format, not legal advice. Template licence: MIT.

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