EU Declaration of Conformity (Art. 47, Annex V)
Official EU Declaration of Conformity template for high-risk AI systems as required by EU AI Act Article 47 and Annex V, including all mandatory fields and reference standards.
This template includes both English and Spanish versions. Scroll down to find "Versión Española".
EU Declaration of Conformity
Article 47 & Annex V — EU AI Act (Regulation (EU) 2024/1689)
Disclaimer: This is guidance only, not legal advice. Consult qualified legal counsel before signing and issuing this declaration. An incorrectly issued Declaration of Conformity may expose the provider to liability under the EU AI Act.
Template provided by VORLUX AI | vorluxai.com
Instructions for Completing This Declaration
Annex V of the EU AI Act mandates specific content for the Declaration of Conformity. This document must:
- Be drawn up for each high-risk AI system separately
- Contain all the information listed in Annex V
- Be kept for 10 years after the AI system has been placed on the market or put into service
- Be made available to national competent authorities on request
- Be updated when a substantial modification is made to the AI system
- Be translated into the official language(s) of Member States where the system is deployed, if required by national authority
═══════════════════════════════════════════════
EU DECLARATION OF CONFORMITY
═══════════════════════════════════════════════
Declaration No.: DOC-____-____-____
Issue Date: ____-__-__
Version: ___
1. Provider Identification
[Annex V §1 — Full name and address of provider]
| Field | Details |
|---|---|
| Legal Entity Name | ___________________________ |
| Trading Name (if different) | ___________________________ |
| Legal Form | ___________________________ |
| Registered Address (Line 1) | ___________________________ |
| Registered Address (Line 2) | ___________________________ |
| City | ___________________________ |
| Postcode | ___________________________ |
| Country (EU Member State) | ___________________________ |
| VAT / Company Registration No. | ___________________________ |
| Contact Email | ___________________________ |
| Contact Telephone | ___________________________ |
| Website | ___________________________ |
Where the provider is not established in the EU:
| Field | Details |
|---|---|
| EU Authorised Representative Name | ___________________________ |
| EU Authorised Representative Address | ___________________________ |
| EU Authorised Representative Contact | ___________________________ |
| Mandate Reference | ___________________________ |
2. AI System Identification
[Annex V §2 — Name and type of the AI system, version information]
| Field | Details |
|---|---|
| AI System Name | ___________________________ |
| Product / Model Reference | ___________________________ |
| Version Number | ___________________________ |
| Software Version / Build ID | ___________________________ |
| Serial Number (if applicable) | ___________________________ |
| Batch / Lot Number (if applicable) | ___________________________ |
| Unique Identifier (UUID/SKU) | ___________________________ |
| Date of Manufacture / Release | ____-__-__ |
Brief System Description:
[Provide a concise description of what the AI system does, sufficient to identify it
clearly. Example: "An AI-based recruitment screening tool that analyses CVs and
ranks candidates for shortlisting, intended for use by HR professionals in
medium-to-large enterprises."]High-Risk Classification:
- Annex III Item:
_____ - Category:
___________________________ - Deployment Context:
___________________________
3. Statement of Conformity
[Annex V §3 — Statement that the AI system is in conformity with this Regulation]
This EU Declaration of Conformity is issued under the sole responsibility of the provider identified in Section 1 above.
The AI system identified in Section 2:
is in conformity with Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts.
Specifically, the AI system complies with the following provisions of Regulation (EU) 2024/1689:
| Provision | Subject Matter | Compliant |
|---|---|---|
| Article 9 | Risk management system | ☐ Yes ☐ N/A |
| Article 10 | Data and data governance | ☐ Yes ☐ N/A |
| Article 11 | Technical documentation | ☐ Yes ☐ N/A |
| Article 12 | Record-keeping | ☐ Yes ☐ N/A |
| Article 13 | Transparency and provision of information | ☐ Yes ☐ N/A |
| Article 14 | Human oversight | ☐ Yes ☐ N/A |
| Article 15 | Accuracy, robustness and cybersecurity | ☐ Yes ☐ N/A |
| Article 17 | Quality management system | ☐ Yes ☐ N/A |
| Article 49 | Registration in EU database | ☐ Yes ☐ N/A |
4. Reference to Applicable Harmonised Standards
[Annex V §4 — Where relevant, reference to harmonised standards applied]
Harmonised standards applied (tick all that apply and fill in details):
| Standard | Title | Version | Applied |
|---|---|---|---|
| EN ISO/IEC 42001 | Information technology — Artificial intelligence — Management system | ____ | ☐ Full ☐ Partial ☐ No |
| ISO/IEC 27001 | Information security management systems | ____ | ☐ Full ☐ Partial ☐ No |
| ISO/IEC 27701 | Privacy information management | ____ | ☐ Full ☐ Partial ☐ No |
| ISO/IEC 23894 | AI — Guidance on risk management | ____ | ☐ Full ☐ Partial ☐ No |
| ISO/IEC 38507 | Governance of IT — Governance implications of the use of AI | ____ | ☐ Full ☐ Partial ☐ No |
| CEN/CENELEC TR 17279 | AI — Overview of trustworthiness | ____ | ☐ Full ☐ Partial ☐ No |
| ETSI EN 303 645 | Cyber security for consumer IoT (if applicable) | ____ | ☐ Full ☐ Partial ☐ No |
Other: ___________ | ___________ | ____ | ☐ Full ☐ Partial ☐ No |
Note on partial application: Where a standard has been applied only partially, specify which clauses or elements were applied and which were not, with justification:
[List clauses applied, clauses not applied, and reason for non-application]5. Reference to Other EU Legislation
[Annex V §5 — Reference to any other relevant Union harmonisation legislation applied]
Where the AI system also falls within the scope of other EU harmonisation legislation, declare conformity with that legislation here:
| Regulation / Directive | Reference | Conformity Status |
|---|---|---|
| GDPR (Regulation (EU) 2016/679) | ☐ Applies | ___________ |
| Medical Device Regulation (EU) 2017/745 | ☐ Applies | ___________ |
| Machinery Regulation (EU) 2023/1230 | ☐ Applies | ___________ |
| Radio Equipment Directive 2014/53/EU | ☐ Applies | ___________ |
| General Product Safety Regulation | ☐ Applies | ___________ |
| NIS2 Directive (EU) 2022/2555 | ☐ Applies | ___________ |
Other: ___________ | ☐ Applies | ___________ |
6. Notified Body Information
[Annex V §6 — Where applicable, notified body name and number]
☐ Route A (Annex VI) — Internal Control: No notified body involvement. Declaration is based on provider’s internal conformity assessment.
☐ Route B (Annex VII) — Notified Body Assessment: The following notified body was involved:
| Field | Details |
|---|---|
| Notified Body Name | ___________________________ |
| Notified Body EU Reference Number | ___________________________ |
| Notified Body Address | ___________________________ |
| Type of Assessment Performed | ☐ Annex VII Module B (type-examination) ☐ Annex VII Module D (QMS) ☐ Other |
| Certificate / Report Reference | ___________________________ |
| Certificate Issue Date | ____-__-__ |
| Certificate Validity Date | ____-__-__ |
7. Technical Documentation Reference
[Supporting evidence — not an Annex V requirement but strongly recommended]
| Document | Reference | Version | Location |
|---|---|---|---|
| Annex IV Technical Documentation | TDD-____-____ | ___ | [Secure document store] |
| Risk Management Report | RMR-____-____ | ___ | [Secure document store] |
| Data Governance Report | DGR-____-____ | ___ | [Secure document store] |
| QMS Documentation | QMS-____-____ | ___ | [Secure document store] |
| Conformity Assessment Report | CAR-____-____ | ___ | [Secure document store] |
8. Signature and Authorisation
[Annex V §7 — Place and date of issue; name, function and signature of person authorised to sign]
This declaration is signed on behalf of the provider by:
Place of Issue: ___________________________
Date of Issue: ____-__-__
| Field | Details |
|---|---|
| Full Name | ___________________________ |
| Function / Title | ___________________________ |
| Department | ___________________________ |
___________________________ |
Signature:
___________________________
[Wet signature or qualified electronic signature (QES) required for official use]Company Stamp / Seal: (where required by national law)
[STAMP / SEAL]Declaration Version Control
| Version | Date | Author | Changes |
|---|---|---|---|
| 1.0 | ____-__-__ | ___________ | Initial issue |
___ | ____-__-__ | ___________ | ___________ |
Post-Issuance Obligations
After signing this declaration, the provider must:
| Obligation | Deadline | Status |
|---|---|---|
| Retain declaration for 10 years after last placement on market | Ongoing | ☐ Confirmed |
| Provide to national competent authority on request | Within period specified by authority | ☐ Procedure in place |
| Update declaration if substantial modification made to system | Before modified system is placed on market | ☐ Process defined |
| Update declaration if new EU harmonised standards become applicable | Upon publication and after transition period | ☐ Monitoring in place |
| Ensure EU authorised representative holds copy (if non-EU provider) | At time of issue | ☐ Confirmed |
| Include reference/link to declaration in instructions for use | At time of issue | ☐ Confirmed |
| Register or update entry in EU AI systems database (Art. 49) | Before placement on market | ☐ Completed — Reg. No.: ___ |
Substantial Modification Checklist
A new or updated declaration is required whenever the AI system undergoes a substantial modification. Review the following after any system change:
| Change Type | Substantial Modification? | New Declaration Required? |
|---|---|---|
| Change to intended purpose | Almost always YES | YES |
| Change to Annex III category | YES | YES |
| Significant change to model architecture | Assess case-by-case | Likely YES |
| Retraining on materially different data | Assess case-by-case | May be required |
| Security patch only | Usually NO | NO |
| UI/interface change only | Usually NO | NO |
| Performance improvement without architectural change | Assess case-by-case | May be required |
| Deployment to new Member State | NO (update instructions only) | NO (update registration) |
Decision Rule: When in doubt, consult legal counsel and document the decision rationale.
Template provided by VORLUX AI | vorluxai.com | This is guidance only, not legal advice.
Versión Española
Declaración de Conformidad de la UE
Artículo 47 & Anexo V — EU AI Act (Regulación (UE) 2024/1689)
Aviso: Este es solo una guía, no asesoramiento legal. Consulte a un abogado calificado antes de firmar e emitir esta declaración. Una Declaración de Conformidad emitida incorrectamente puede exponer al proveedor a responsabilidad bajo la EU AI Act.
Plantilla proporcionada por VORLUX AI | vorluxai.com
Instrucciones para completar esta declaración
El Anexo V de la EU AI Act establece contenido específico para la Declaración de Conformidad. Este documento debe:
- Ser elaborado para cada sistema de inteligencia artificial de alto riesgo por separado
- Contener toda la información enumerada en el Anexo V
- Ser mantenida durante 10 años después de que el sistema de inteligencia artificial haya sido puesto en el mercado o puesta en servicio
- Ser facilitada a las autoridades competentes nacionales a petición
- Ser actualizada cuando se realice una modificación sustancial al sistema de inteligencia artificial
- Ser traducida a los idiomas oficiales de los Estados miembros donde el sistema está desplegado, si lo requiere la autoridad nacional
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DECLARACIÓN DE CONFORMIDAD DE LA UE
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Número de Declaración: DOC-____-____-____
Fecha de emisión: ____-__-__
Versión: ___
1. Identificación del proveedor
[Anexo V §1 — Nombre y dirección completa del proveedor]
| Campo | Detalles |
|---|---|
| Nombre Legal de la Entidad | ___________________________ |
| Razón Social (si es diferente) | ___________________________ |
| Forma Jurídica | ___________________________ |
| Dirección Registrada (Línea 1) | ___________________________ |
| Dirección Registrada (Línea 2) | ___________________________ |
| Ciudad | ___________________________ |
| Código Postal | ___________________________ |
| País (Estado miembro de la UE) | ___________________________ |
| Número de Identificación Fiscal / Registro Comercial | ___________________________ |
| Correo Electrónico de Contacto | ___________________________ |
| Teléfono de Contacto | ___________________________ |
| Sitio Web | ___________________________ |
Si el proveedor no está establecido en la UE:
| Campo | Detalles |
|---|---|
| Nombre del Representante Autorizado por la UE | ___________________________ |
| Dirección del Representante Autorizado por la UE | ___________________________ |
| Contacto del Representante Autorizado por la UE | ___________________________ |
| Referencia de Mandato | ___________________________ |
2. Identificación del Sistema de Inteligencia Artificial
[Anexo V §2 — Nombre y tipo del sistema de inteligencia artificial, información de versión]
| Campo | Detalles |
|---|---|
| Nombre del Sistema de Inteligencia Artificial | ___________________________ |
| Referencia del Producto / Modelo | ___________________________ |
| Número de Versión | ___________________________ |
| Versión del Software / ID de Compilación | ___________________________ |
| Número de Serie (si corresponde) | ___________________________ |
| Número de Lote / Lot (si corresponde) | ___________________________ |
| Identificador Único (UUID/SKU) | ___________________________ |
| Fecha de Fabricación / Lanzamiento | ____-__-__ |
Descripción del Sistema Breve:
[Proporcione una descripción concisa de qué hace el sistema de inteligencia artificial, suficiente para identificarlo claramente. Ejemplo: "Una herramienta de screening de inteligencia artificial basada en CV que analiza y clasifica a los candidatos para su selección, destinada al uso por profesionales de RRHH en empresas medianas y grandes."]Clasificación de Alto Riesgo:
- Anexo III Item:
_____ - Categoría:
___________________________ - Contexto de Despliegue:
___________________________
3. Declaración de Conformidad
[Anexo V §3 — Declaración de que el sistema de inteligencia artificial es conforme con esta regulación]
Esta Declaración de Conformidad de la UE se emite bajo la responsabilidad exclusiva del proveedor identificado en la Sección 1 anterior.
El sistema de inteligencia artificial identificado en la Sección 2:
es conforme con la Regulación (UE) 2024/1689 del Parlamento Europeo y del Consejo de 13 de junio de 2024 que establece normas armonizadas sobre la inteligencia artificial (Artificial Intelligence).