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

AI・機械学習標準EU AI Act Art. 47, Annex Vact declaration conformity更新 2026/10/29

エディタで開く.mdをダウンロード

使い方: 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.

プレビュー

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

Field	Value
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Status	[Draft / Signed / Superseded / Withdrawn]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 updated	YYYY-MM-DD

Approvals

Role	Name	Decision	Date
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

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

1. Context and conformity route

Question	Answer
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 procedure	Example: 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

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

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

Field	Value
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

Field	Value
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

Reference	Title	Parts 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)

Field	Value
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

Field	Value
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 trigger	Action	Owner
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 request	Provide to national competent authorities on request	[@regulatory-lead]
Change of provider details	Update declaration version	[@legal]
Substantial modification	New conformity assessment and new declaration	[@quality-manager]
New or revised harmonised standard applied	Update 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.