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Annex IV Technical Documentation
Detailed Annex IV documentation template aligned with Art. 11 and related EU AI Act obligations.
Category: High-Risk Documentation • Risk level: High
# Annex IV Technical Documentation Template (EU AI Act) > **Legal basis:** Annex IV + Art. 11 and related obligations (EU AI Act 2024/1689) > **Use case:** High-risk AI systems requiring structured technical documentation > **Document owner:** [Name / Role] > **Document version:** [vX.Y] > **Last updated:** [YYYY-MM-DD] --- ## 0) Document Governance - System name: [System] - Unique system identifier: [ID] - Provider legal entity: [Entity] - Documentation owner: [Name] - Review cycle: [Monthly/Quarterly] - Approval authority: [Role] - Linked files repository: [URL/path] **Guidance:** Annex IV documentation must be controlled, versioned, and auditable. --- ## 1) General Description of the AI System 1.1 Intended purpose: [Describe core purpose] 1.2 Scope of use: [In-scope/out-of-scope] 1.3 Target users/operators: [Who uses it] 1.4 Affected persons/groups: [Who is impacted] 1.5 Deployment context: [Sector/region/process] 1.6 Lifecycle stage: [Development/pilot/production] 1.7 Functional boundaries: [What it does not do] 1.8 Foreseeable misuse summary: [Known misuse scenarios] **Common mistake:** vague purpose statements that cannot be audited. --- ## 2) Design Specifications and Architecture 2.1 System architecture overview (diagram reference): [Ref] 2.2 Core components/modules: [List] 2.3 Model type(s): [Classifier/LLM/ranker/etc.] 2.4 Input channels and interfaces: [APIs/UI/streams] 2.5 Output formats and confidence signals: [Format] 2.6 Decision logic and thresholds: [Rules] 2.7 External dependencies/vendors: [List] 2.8 Infrastructure environment: [Cloud/on-prem] **Guidance:** include enough detail for technical and regulatory review. --- ## 3) Development Process and Validation 3.1 Development methodology: [SDLC/MLOps approach] 3.2 Data split strategy: [Train/validation/test] 3.3 Performance metrics used: [Precision/recall/etc.] 3.4 Acceptance thresholds: [Threshold table] 3.5 Robustness/stress testing summary: [Results] 3.6 Adversarial or misuse testing summary: [Results] 3.7 Human evaluation steps: [Who/when] 3.8 Known limitations and failure modes: [List] **Related articles:** Art. 15 (accuracy, robustness, cybersecurity). --- ## 4) Data Requirements and Governance 4.1 Data sources and provenance: [Source list] 4.2 Data collection method: [Method] 4.3 Data relevance/representativeness checks: [Method] 4.4 Data quality metrics: [Completeness, consistency] 4.5 Labeling and annotation controls: [Process] 4.6 Bias detection/testing approach: [Method] 4.7 Data cleaning and preprocessing pipeline: [Summary] 4.8 Data retention/deletion policy: [Policy] 4.9 Personal data handling and GDPR interfaces: [Summary] **Related article:** Art. 10 data governance. --- ## 5) Risk Management and Control Measures 5.1 Risk management framework reference: [Doc] 5.2 Identified harms and risk scenarios: [Table] 5.3 Risk scoring methodology: [Likelihood x severity] 5.4 Mitigation controls per risk: [Control list] 5.5 Residual risk acceptance process: [Process] 5.6 Escalation and incident triggers: [Thresholds] 5.7 Reassessment cadence: [Frequency] **Related article:** Art. 9 risk management system. --- ## 6) Human Oversight Measures 6.1 Oversight roles and responsibilities: [Roles] 6.2 Human intervention points: [Workflow steps] 6.3 Override/stop mechanisms: [Controls] 6.4 User instruction/training plan: [Program] 6.5 Escalation authority map: [Who can decide] 6.6 Safeguards against automation bias: [Measures] **Related article:** Art. 14 human oversight. --- ## 7) Logging, Monitoring, and Post-Market Activities 7.1 Logging scope/events captured: [Events] 7.2 Log retention and integrity controls: [Policy] 7.3 Monitoring KPIs and thresholds: [KPI table] 7.4 Drift/performance degradation checks: [Method] 7.5 Incident handling workflow: [Process] 7.6 Corrective action workflow: [Process] 7.7 Post-market review cadence: [Schedule] **Related articles:** Art. 12 (record-keeping), Art. 72+ (monitoring/incident context). --- ## 8) Conformity and Regulatory Information 8.1 Conformity assessment route: [Internal / notified body] 8.2 Harmonised standards used: [Standards list] 8.3 Common specifications used: [If any] 8.4 CE marking status: [Status] 8.5 EU declaration of conformity reference: [Doc] 8.6 EU database registration status/ID: [Status/ID] 8.7 Notified body details (if applicable): [Entity] **Related articles:** Art. 43, Art. 47, Art. 49. --- ## 9) Cybersecurity and Resilience 9.1 Threat model summary: [Model] 9.2 Access control model: [IAM/segmentation] 9.3 Secure update process: [Procedure] 9.4 Vulnerability management process: [Procedure] 9.5 Backup/recovery strategy: [Plan] 9.6 Business continuity assumptions: [Assumptions] --- ## 10) Documentation Quality Checks - [ ] All sections complete and current - [ ] Technical claims evidenced by test artifacts - [ ] Legal references reviewed with compliance owner - [ ] Version control and approvals recorded - [ ] External dependencies and third-party assumptions documented --- ## 11) Annexes - Annex A: Architecture diagrams - Annex B: Data dictionaries - Annex C: Validation test reports - Annex D: Risk register extracts - Annex E: User instructions and oversight SOPs - Annex F: Conformity evidence bundle --- ## Fillable Sign-Off - Prepared by: [Name / Date] - Reviewed by (Technical): [Name / Date] - Reviewed by (Compliance): [Name / Date] - Approved by: [Name / Date]