AIGO — EU AI Act Conformity and Documentation Mapping
1. Document Purpose
This document provides the AIGO mapping for the conformity-assessment, technical-documentation, quality-management, declaration, registration, notified-body, and related documentation requirements of Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744. The mapping translates these requirements into AIGO governance mechanisms covering:- conformity applicability;
- conformity-assessment pathway selection;
- technical documentation;
- quality-management systems;
- record keeping;
- logs;
- declaration of conformity;
- CE marking;
- notified bodies;
- notifying authorities;
- EU registration;
- post-market documentation;
- corrective action;
- regulatory evidence;
- assurance;
- change management;
- document integrity;
- management review; and
- retirement.
2. Mapping Information
Regulation (EU) 2026/1744 made targeted changes to Article 43 concerning conformity assessment and notified-body arrangements, including transitional provisions for certain notified bodies already designated under the Union harmonisation legislation listed in Annex I.
3. Source Hierarchy
3.1 Binding Legal Source
The primary source is: Regulation (EU) 2024/1689 as amended by applicable subsequent Union legislation, including: Regulation (EU) 2026/1744. The current EUR-Lex legal text is authoritative.3.2 Official Implementation Material
Supporting sources include:- European Commission guidance;
- European AI Office guidance;
- official FAQs;
- implementing acts;
- delegated acts;
- harmonised standards;
- common specifications;
- notified-body information;
- Commission implementation material.
3.3 AIGO Mapping
AIGO translates the legal requirements into organizational governance mechanisms. AIGO controls, assessments, approvals, and assurance activities are not automatically statutory conformity procedures.4. Conformity Governance Principle
Conformity governance should follow:5. Conformity Applicability
Before establishing a conformity workflow, AIGO should determine:- whether the AI system is high-risk;
- whether Article 6(1) or Article 6(2) applies;
- whether an applicable product-law pathway exists;
- whether a third-party conformity assessment is required;
- whether internal control is permitted;
- whether notified-body involvement is required;
- whether an exemption or special pathway applies;
- whether transition provisions apply.
6. Conformity Decision Record
AIGO should maintain a controlled conformity applicability assessment containing:7. AIGO Conformity Control
Control Name: AI Act Conformity Assessment Governance Objective: Ensure that applicable conformity-assessment requirements are identified, assigned, documented, completed, evidenced, and maintained through the AI system lifecycle. Control Owner: AI Governance Owner / Compliance Owner / AI System Owner. Frequency:- before applicable market placement or putting into service;
- after material change;
- when legal requirements change;
- when conformity-assessment conditions change;
- during post-market obligations.
8. Relationship Between AIGO Assurance and Conformity Assessment
AIGO shall maintain a strict distinction:- readiness;
- control design;
- control implementation;
- evidence;
- documentation;
- risk management;
- monitoring.
9. Article 11 — Technical Documentation
9.1 Legal Theme
Providers of high-risk AI systems must draw up and maintain the technical documentation required by Article 11 and Annex IV. The documentation must allow authorities and, where relevant, notified bodies to assess compliance with the applicable requirements. The Regulation requires at least the information specified in Annex IV.9.2 AIGO Mapping
Relationship:DIRECT / CRITICAL
AIGO Components:
- AI System;
- Governance;
- Risk;
- Control;
- Assessment;
- Evidence;
- Change;
- Assurance.
10. Technical Documentation Control
Control Name: High-Risk AI Technical Documentation The control should ensure that applicable technical documentation:- exists;
- is complete;
- is current;
- is version-controlled;
- is internally consistent;
- is traceable;
- is retained;
- can be provided to authorized authorities or notified bodies where required.
11. Technical Documentation — General System Description
Annex IV requires a general description including, as applicable:- intended purpose;
- provider name;
- system version;
- relationship to previous versions;
- interaction with hardware and software;
- relevant software or firmware versions;
- update requirements;
- forms of market placement or putting into service;
- intended hardware environment;
- product-component information.
AIGO Mapping
These elements should map to:- AI System Profile;
- Change Management;
- Evidence;
- Configuration Management.
12. Technical Documentation — Intended Purpose
The intended purpose should be:- explicitly defined;
- approved;
- version-controlled;
- linked to classification;
- linked to risk;
- linked to controls;
- reassessed after material change.
13. Technical Documentation — System Version
AIGO should preserve:14. Technical Documentation — System Interfaces
Documentation should describe relevant interactions with:- software;
- hardware;
- APIs;
- external systems;
- other AI systems;
- data services;
- identity systems;
- monitoring platforms.
15. Technical Documentation — Lifecycle Versions
The documentation should preserve relationships among:16. Technical Documentation — Design and Development
Where applicable, the technical documentation should capture:- design specifications;
- architecture;
- computational methods;
- model structure;
- development process;
- data requirements;
- testing;
- validation;
- verification;
- performance;
- limitations.
17. Technical Documentation — Data
Documentation should include relevant information about:- training data;
- validation data;
- testing data;
- data governance;
- data provenance;
- data preparation;
- quality;
- bias;
- representativeness;
- data-processing choices.
18. Technical Documentation — Risk Management
Technical documentation should remain traceable to the applicable risk-management process. Recommended chain:19. Technical Documentation — Testing and Validation
The documentation should preserve applicable:- test plans;
- test datasets;
- validation methods;
- acceptance criteria;
- test results;
- known failures;
- remediation;
- retesting.
20. Technical Documentation — Accuracy
Where accuracy requirements apply, documentation should identify:- accuracy objectives;
- performance measures;
- measurement methods;
- validation results;
- limitations;
- monitoring;
- changes.
21. Technical Documentation — Robustness
Documentation should address applicable:- robustness requirements;
- expected failure modes;
- stress tests;
- resilience;
- failure handling;
- degradation behavior.
22. Technical Documentation — Cybersecurity
Documentation should address relevant cybersecurity measures, including:- threat model;
- security architecture;
- vulnerabilities;
- protective controls;
- testing;
- incident response;
- updates.
23. Technical Documentation — Human Oversight
Where applicable, documentation should describe:- human oversight arrangements;
- roles;
- intervention;
- override;
- limitations;
- escalation;
- competence requirements.
24. Technical Documentation — Logging
Documentation should identify:- what is logged;
- how logging operates;
- applicable retention;
- integrity measures;
- access controls;
- review mechanisms.
25. Article 12 — Record-Keeping
25.1 AIGO Mapping
Relationship:DIRECT
AIGO should provide:
High-Risk Record-Keeping Control
The control should manage:
- automatic logs where required;
- records;
- access;
- retention;
- integrity;
- traceability;
- incident linkage.
26. Record-Keeping Evidence
AIGO should retain evidence showing:- logging was enabled;
- logs were produced;
- log configuration;
- changes;
- access;
- retention;
- relevant incidents.
27. Article 16 — Provider Documentation and Compliance Responsibilities
Provider obligations should be distributed across the AIGO lifecycle. Recommended chain:28. Article 17 — Quality Management System
28.1 Legal Theme
Providers of high-risk AI systems must establish a quality-management system addressing the applicable requirements.28.2 AIGO Mapping
Relationship:DIRECT / SUPPORTING
AIGO may provide governance structures supporting the QMS through:
- policies;
- procedures;
- roles;
- design controls;
- testing;
- risk management;
- documentation;
- records;
- corrective action;
- monitoring;
- supplier management.
29. QMS Documentation
The QMS should be represented through controlled records where required. Potential evidence:- policy;
- procedures;
- responsibilities;
- change management;
- testing;
- data governance;
- risk management;
- corrective action;
- record keeping;
- internal review.
30. QMS and Existing Management Systems
Where an organization already maintains:- quality management;
- information security;
- privacy management;
- safety management;
- product compliance;
31. Article 18 — Documentation Retention
AIGO should map retention obligations to the Evidence and Document Integrity frameworks. Retention controls should capture:- artifact;
- legal basis;
- retention period;
- start event;
- repository;
- access;
- disposition;
- legal hold.
32. Article 19 — Automatically Generated Logs
AIGO should integrate logs with:- Monitoring;
- Evidence;
- Incident;
- Assurance.
33. Articles 20–22 — Corrective Action and Cooperation
Where conformity or market-surveillance findings identify non-compliance, AIGO should provide:- corrective action;
- change;
- verification;
- evidence;
- regulatory communication.
34. Article 43 — Conformity Assessment
34.1 Legal Theme
Article 43 establishes conformity-assessment procedures for high-risk AI systems. The applicable procedure depends on the relevant high-risk pathway and legal conditions. The AI Act includes internal-control and third-party-assessment routes through Annexes VI and VII, with specific rules depending on the system and applicable Union harmonisation legislation.34.2 AIGO Mapping
Relationship:DIRECT / CRITICAL
35. Conformity Pathway Decision
AIGO should establish a formal determination of:36. Internal Control Route
Where the applicable legal pathway permits conformity assessment based on internal control, AIGO may support the organizational process through:- quality management;
- risk management;
- technical documentation;
- control assessment;
- evidence;
- internal review;
- corrective action.
37. Third-Party Conformity Assessment
Where a notified body is required, the AIGO governance model should support:- notified-body selection;
- scope verification;
- contract;
- assessment preparation;
- evidence package;
- correspondence;
- findings;
- corrective actions;
- certificate;
- surveillance;
- re-assessment.
38. Notified Body Governance
AIGO should maintain a controlled notified-body record containing:- organization name;
- notification status;
- scope;
- applicable product / AI system categories;
- notification authority;
- assessment scope;
- certificate;
- validity;
- surveillance;
- communications.
39. Notifying Authority Relationship
The notifying authority supervises notified bodies. AIGO should distinguish:40. Article 43 Amendment Baseline
Regulation (EU) 2026/1744 made targeted changes to Article 43. The amendment:- corrects the relationship between conformity-assessment requirements and provider obligations;
- clarifies interaction with Union harmonisation legislation;
- permits specified notified bodies already notified under relevant product legislation to conduct certain AI conformity assessments during an 18-month transitional period beginning 27 July 2026, without prejudice to the general notification regime under Article 28.
41. Notified-Body Transition Control
For Article 6(1)/Annex I systems, AIGO should capture:- notified-body legal basis;
- existing product-law notification;
- AI Act notification status;
- transitional authority where applicable;
- assessment scope;
- transition expiry;
- current verification source.
42. Article 44 — Certificates
Where a conformity certificate is issued under the applicable procedure, AIGO should record:- certificate identifier;
- notified body;
- system;
- scope;
- issue date;
- expiry date where applicable;
- version;
- conditions;
- surveillance;
- related documentation.
43. Certificate Integrity
Certificates should be treated as controlled evidence. AIGO should verify:- source;
- issuer;
- validity;
- scope;
- system identity;
- version;
- relationship to technical documentation.
44. Certificate Change Management
Changes should trigger review of certificate status where they affect:- system version;
- intended purpose;
- architecture;
- conformity scope;
- product;
- applicable legal requirements.
45. Article 45 — Changes to High-Risk Systems
AIGO should link material changes to:- conformity reassessment;
- documentation update;
- risk reassessment;
- control assessment;
- certificate impact;
- declaration impact;
- registration impact.
46. Article 46 — Certain Procedures for Product-Related Systems
For certain Article 6(1) systems, conformity assessment interacts with the relevant Union harmonisation legislation. AIGO should therefore retain:- product regulation;
- applicable conformity module;
- AI Act relationship;
- notified body;
- assessment record;
- certificate;
- declaration.
47. Article 47 — EU Declaration of Conformity
47.1 AIGO Mapping
Relationship:DIRECT / CRITICAL
Where required, the organization should maintain the EU declaration of conformity as a distinct legal artifact.
AIGO should provide:
- document control;
- version;
- approval;
- evidence;
- applicable legal references;
- change linkage;
- retention.
48. Declaration of Conformity Control
Control Name: EU Declaration of Conformity Governance The control should ensure:- correct declaration exists where required;
- responsible signer is identified;
- applicable system is identified;
- applicable legislation is identified;
- version is current;
- declaration is retained;
- changes trigger review.
49. Declaration Evidence
Potential evidence includes:- signed declaration;
- version;
- legal references;
- product/system identifier;
- authorized signatory;
- date;
- supporting conformity records.
50. Article 48 — CE Marking
Where applicable, CE marking should be managed as a distinct regulatory artifact and product-compliance activity. AIGO should maintain:- applicability;
- marking design;
- product/system version;
- declaration relationship;
- assessment basis;
- evidence.
51. Article 49 — Registration
Where registration requirements apply, AIGO should connect:52. EU Database Registration Control
Control Name: AI Act Registration Governance The control should manage:- registration applicability;
- responsible owner;
- submission;
- registration identifier;
- update triggers;
- evidence;
- regulatory communication.
53. Registration Change Management
Changes may require registration updates. AIGO should identify:- system change;
- legal change;
- provider change;
- intended-purpose change;
- registration impact;
- update requirement.
54. Annex IV — Technical Documentation Architecture
AIGO should use Annex IV as the primary technical-documentation baseline for applicable high-risk AI systems. The documentation architecture should cover, as applicable:55. AIGO Technical Documentation Profile
The AI System Profile should provide the operational foundation for technical documentation, while preserving the distinction between:56. Technical Documentation and Evidence
Every material technical-documentation component should have:- owner;
- version;
- source;
- review;
- applicability;
- evidence;
- change history.
57. Technical Documentation and Change
The Change Management process should automatically identify documentation impacts. Potential triggers:- new model;
- model update;
- architecture change;
- training-data change;
- hardware change;
- API change;
- intended-purpose change;
- new deployment context;
- security change;
- human-oversight change.
58. Technical Documentation and Assurance
Assurance may assess:- completeness;
- consistency;
- version alignment;
- evidence;
- risk linkage;
- change history.
59. Simplified Documentation for SMEs
The AI Act provides for simplified technical documentation for eligible SMEs, including start-ups, through a Commission-established form where the applicable requirements are met. AIGO should record:- SME status;
- eligibility;
- use of simplified documentation;
- applicable form;
- approval;
- evidence.
60. Technical Documentation and Document Integrity
The AIGO Document Integrity Checker should verify:- file exists;
- version;
- integrity;
- references;
- completeness of required sections;
- controlled status.
61. Technical Documentation and Framework Consistency
The Framework Consistency Checker should verify:- system identifier;
- version;
- intended purpose;
- provider;
- classification;
- applicable controls;
- related assessments;
- registration;
- declaration;
- certificate.
62. Technical Documentation and Evidence Coverage
The Evidence Coverage Validator should identify required documentation components that are absent or stale. Examples:63. Quality Management and Document Control
The QMS should ensure that documentation changes are:- authorized;
- reviewed;
- approved;
- versioned;
- distributed appropriately;
- retained;
- traceable.
64. Regulatory Evidence Pack
For applicable high-risk systems, organizations should be able to assemble a controlled evidence package containing, as relevant:65. Evidence-Pack Integrity
The evidence pack should include:- system version;
- evidence date;
- source identifiers;
- checksums where required;
- repository references;
- review status.
66. Market-Placement Readiness
Before placing an applicable high-risk AI system on the market or putting it into service, AIGO should evaluate:- classification;
- risk management;
- documentation;
- QMS;
- conformity assessment;
- declaration;
- CE marking where applicable;
- registration where applicable;
- monitoring;
- human oversight;
- evidence.
67. Putting-Into-Service Gate
A controlled deployment gate may be:68. Post-Market Documentation
AIGO should retain relevant:- monitoring records;
- incidents;
- corrective actions;
- changes;
- complaints;
- authority interactions;
- performance evidence;
- surveillance findings.
69. Corrective Action Documentation
When a non-conformity is found:70. Conformity and Incident Management
A serious incident may require:- regulatory reporting;
- corrective action;
- documentation update;
- conformity reassessment;
- monitoring changes;
- risk reassessment.
71. Conformity and Change Management
Material change should trigger:- legal applicability assessment;
- risk assessment;
- documentation update;
- conformity-impact analysis;
- certificate review;
- declaration review;
- registration review.
72. Conformity and Assurance
AIGO assurance should determine whether the organization is prepared to undergo the applicable conformity process. Possible assurance outputs:- readiness;
- gap;
- evidence sufficiency;
- documentation consistency;
- control coverage;
- unresolved issue.
73. Conformity and Management Review
Management review may consider:- conformity readiness;
- open assessment findings;
- certificate status;
- notified-body relationship;
- regulatory deadlines;
- documentation gaps;
- incidents;
- post-market findings;
- corrective actions.
74. Conformity and Retirement
Retirement should consider:- certificate history;
- declarations;
- registration;
- technical documentation;
- logs;
- incidents;
- authority communications;
- retention requirements.
75. Notified-Body Evidence
Where a notified body is involved, evidence should include:- body identity;
- notification scope;
- assessment agreement;
- assessment reports;
- findings;
- responses;
- certificate;
- surveillance;
- correspondence.
76. Notified-Body Change Management
The organization should reassess notified-body status when:- legal scope changes;
- notification changes;
- the body loses scope;
- certificates change;
- new AI-system categories become applicable;
- transition provisions expire.
77. Conformity Timeline Governance
The current amendment baseline changed the implementation timetable for high-risk obligations. The Commission currently states that specified Annex III high-risk systems become subject to the strict high-risk obligations from 2 December 2027, while AI systems embedded in regulated products under the Annex I pathway are subject to those obligations from 2 August 2028. The dedicated timeline document is authoritative:11-AIGO-EU-AI-Act-Applicability-and-Timeline-v0.1.md
78. Current Conformity Readiness Principle
AIGO should distinguish:79. Conformity and Digital Omnibus
Regulation (EU) 2026/1744 should be incorporated into the AIGO conformity baseline. It changed, among other matters:- Article 43 conformity-assessment provisions;
- notified-body transition arrangements;
- interaction with Union harmonisation legislation;
- QMS relationship;
- implementation timing.
80. Current Legal-Source Rule
Before approving a conformity mapping release, AIGO should verify:- current EUR-Lex consolidated text;
- amendments;
- applicable implementing acts;
- delegated acts;
- current Commission guidance;
- current notified-body information;
- relevant standards and common specifications.
81. Conformity Mapping Control Matrix
82. Technical Documentation Traceability
The minimum traceability chain is:83. Conformity Traceability
The preferred chain is:84. Conformity Findings
Potential AIGO findings include:85. Critical Conformity Findings
Potential critical findings include:- applicable conformity procedure not determined;
- required third-party assessment not performed;
- technical documentation materially absent;
- required declaration absent;
- required certificate absent;
- certificate does not cover the system;
- notified-body eligibility not established;
- required registration absent;
- material system change without conformity-impact analysis.
86. Evidence Requirements
A conformity evidence set may contain:87. Evidence Quality
Conformity evidence should be:- attributable;
- current;
- version-specific;
- traceable;
- complete;
- protected;
- reviewable.
88. Document Integrity
The Document Integrity Checker should verify:- file existence;
- readability;
- version;
- status;
- integrity;
- links;
- document control;
- metadata.
89. Framework Consistency
The Framework Consistency Checker should verify consistency among:- AI System Profile;
- classification;
- technical documentation;
- risk;
- QMS;
- certificate;
- declaration;
- registration;
- monitoring;
- changes.
90. Control Coverage
The Control Coverage Validator should determine whether required conformity-supporting controls exist. A control being present does not prove statutory conformity.91. Evidence Coverage
The Evidence Coverage Validator should identify missing or stale conformity evidence. A missing evidence record means the governance system cannot demonstrate the activity through the repository; it does not by itself prove that the activity never occurred.92. Assurance Coverage
The Assurance framework should identify which conformity-supporting activities have been independently or objectively reviewed. Assurance should not be presented as a statutory notified-body assessment unless it legally is one.93. Management Review
Management review should receive:- conformity status;
- open gaps;
- certificates;
- declarations;
- notified-body issues;
- regulatory changes;
- incidents;
- corrective actions;
- evidence gaps.
94. Regulatory Change Management
Conformity requirements should be reviewed after:- amendments;
- implementing acts;
- delegated acts;
- changes in harmonised standards;
- changes in common specifications;
- new Commission guidance;
- notified-body changes;
- sectoral-law changes.
95. Continuous Improvement
Conformity governance improvements may include:- better documentation;
- better version control;
- improved evidence;
- better assessment planning;
- improved notified-body management;
- improved QMS;
- stronger change controls;
- stronger post-market monitoring.
96. Relationship to High-Risk Mapping
This document depends on:03-AIGO-EU-AI-Act-High-Risk-AI-Mapping-v0.1.md
The high-risk mapping determines the relevant classification pathway.
This document then determines the conformity and documentation implications of that pathway.
97. Relationship to Governance and Enforcement
This document depends on:07-AIGO-EU-AI-Act-Governance-and-Enforcement-Mapping-v0.1.md
Regulatory authorities and enforcement relationships should be managed through the governance and enforcement layer.
98. Relationship to Evidence and Assurance
This document feeds:13-AIGO-EU-AI-Act-Evidence-and-Assurance-Mapping-v0.1.md
The detailed evidence and assurance mapping should determine how conformity evidence is preserved and tested.
99. Relationship to Annex Mapping
Detailed Annex I and Annex IV–IX relationships should be maintained in:10-AIGO-EU-AI-Act-Annexes-Mapping-v0.1.md
This document provides the operational conformity architecture and should not duplicate the full annex text.
100. Relationship to AIGO Schemas
No dedicated Conformity Schema is required at this stage.
101. Relationship to AIGO Templates
Relevant existing templates include:- AI System Profile;
- AI Classification;
- AI Risk Assessment;
- AI Control Assessment;
- AI Approval;
- AI Monitoring;
- AI Incident;
- AI Change Management;
- AI Assurance;
- AI Management Review;
- AI Evidence Record;
- AI Retirement.
102. Relationship to AIGO Tools
The mapping should be supported by:- Schema Validator;
- Reference Validator;
- Traceability Validator;
- Control Coverage Validator;
- Evidence Coverage Validator;
- Framework Consistency Checker;
- Document Integrity Checker;
- Repository Health Checker.
103. Validation Requirements
The mapping should satisfy:Legal Source Validation
Articles, Annexes, and amendment references resolve.Classification Validation
The applicable high-risk pathway is identifiable.Conformity Path Validation
The applicable procedure is documented.Documentation Validation
Required documentation components are identified.Evidence Validation
Supporting evidence is defined.Notified-Body Validation
Where relevant, current eligibility and scope are verified.Certificate Validation
Certificate scope and system version are aligned.Declaration Validation
Declaration is present where required and current.Registration Validation
Registration obligations are assessed.Timeline Validation
Application dates and transitions are current.Traceability Validation
Legal requirement → documentation → assessment → conformity → evidence chain is complete.104. Limitations
This mapping cannot independently determine:- whether a particular conformity-assessment route legally applies;
- whether a notified body is legally competent for a particular assessment;
- whether technical documentation is substantively sufficient;
- whether conformity has been demonstrated;
- whether a declaration of conformity is legally valid;
- whether CE marking is lawful;
- whether a product-law conformity procedure is satisfied.
105. Current Official Baseline
The current Commission implementation material states that high-risk AI systems are subject to strict obligations before they can be placed on the market or put into service, including risk management, data quality, logging, technical documentation, information to deployers, human oversight, robustness, cybersecurity, and accuracy. The current application schedule places the relevant Article 6(2)/Annex III obligations from 2 December 2027 and the Article 6(1)/Annex I product-related pathway from 2 August 2028. The Commission’s high-risk classification guidance remains an implementation aid rather than binding law.106. Current Amendment Baseline
Regulation (EU) 2026/1744 is part of the current legal baseline. For conformity governance, particular attention should be paid to its amendments concerning:- Article 43;
- notified-body arrangements;
- interaction with Union harmonisation legislation;
- quality-management systems;
- transitional assessment arrangements.
107. Review Triggers
This mapping should be reviewed when:- the AI Act is amended;
- Article 43 changes;
- technical-documentation requirements change;
- conformity procedures change;
- Annexes change;
- notified-body requirements change;
- implementing acts are adopted;
- delegated acts are adopted;
- harmonised standards materially change;
- common specifications are adopted;
- official Commission guidance changes.
108. Review Frequency
Minimum:- annual;
- event-driven after legal or regulatory change;
- before major AIGO releases.
109. Relationship to Other EU AI Act Mappings
110. Document Control
111. Document Status
Document: AIGO — EU AI Act Conformity and Documentation Mapping Version: 0.1 Status: Draft Working Name: AIGO Full Name: AI Governance Operating Framework Document Identifier:AIGO-MAP-EUAI-008
Document Type: EU AI Act Mapping
This document maps the EU AI Act conformity-assessment and documentation framework to the AIGO AI Governance Operating Framework, including technical documentation, quality management, record keeping, conformity procedures, notified bodies, certificates, declarations, CE marking, registration, corrective action, evidence, assurance, change management, and lifecycle governance.
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