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ai-act-high-risk-docs

Preparing EU AI Act compliance documentation for high-risk AI systems. Covers Annex III classification, technical documentation under Art. 11, conformity assessment, risk management systems, and CE marking requirements. Keywords: EU AI Act, high-risk AI, Annex III, conformity assessment, CE marking.

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EU AI Act High-Risk AI System Documentation

Overview

The EU AI Act (Regulation 2024/1689, entered into force 1 August 2024, with high-risk obligations applicable from 2 August 2026) establishes a risk-based regulatory framework for artificial intelligence systems. High-risk AI systems — those listed in Annex III or used as safety components of products covered by Union harmonisation legislation in Annex I — must meet extensive documentation, transparency, and governance requirements before being placed on the EU market. Cerebrum AI Labs must prepare comprehensive technical documentation, implement a risk management system, ensure data governance, and undergo conformity assessment for each high-risk AI system.

High-Risk Classification

Annex III Categories Relevant to Cerebrum AI Labs

CategoryAnnex III ReferenceCerebrum AI Labs SystemClassification
Employment and workers managementAnnex III, para. 4(a)CV Screening AI — automated filtering of job applicationsHigh-risk
Access to essential servicesAnnex III, para. 5(b)Credit Scoring AI — creditworthiness assessment for financial productsHigh-risk
Law enforcementAnnex III, para. 6(a)Not applicableN/A
Biometric identificationAnnex III, para. 1(a)Facial Verification AI — identity verification at onboardingHigh-risk
Education and vocational trainingAnnex III, para. 3(a)Not applicableN/A

Classification Decision Tree

Is the AI system listed in Annex III?
├── Yes → High-risk (unless exception applies under Art. 6(3))
│   └── Does the system make decisions materially affecting natural persons?
│       ├── Yes → High-risk confirmed
│       └── No → May qualify for Art. 6(3) exception (narrow, profiling, preparatory)
│
├── No → Is it a safety component of a product under Annex I legislation?
│   ├── Yes → High-risk (subject to third-party conformity assessment)
│   └── No → Not high-risk under AI Act
│
└── Is it a general-purpose AI model with systemic risk? (Art. 51)
    ├── Yes → GPAI systemic risk obligations
    └── No → GPAI transparency obligations only

Technical Documentation Requirements (Art. 11)

Annex IV — Required Documentation Content

Section 1: General Description

Document ElementContent for Cerebrum AI Labs CV Screening AI
Intended purposeAutomated screening and ranking of job applications based on qualification match
Provider name and contactCerebrum AI Labs, 42 Innovation Drive, Dublin, Ireland
AI system versionv2.4.1 (deployed March 2026)
Hardware/software requirementsCloud-hosted on EU infrastructure (AWS eu-west-1), Python 3.11, PyTorch 2.2
Product integrationIntegrated into Cerebrum TalentFlow ATS platform

Section 2: Detailed Description of System Elements

ElementDocumentation Required
Development methodologyModel architecture, training approach, design choices and rationale
Computational resourcesTraining compute (GPU hours), energy consumption
Training dataData sources, collection methods, size, labeling methodology, preprocessing
Validation and testingTest datasets, metrics, results, known limitations
Input data specificationsExpected input format, quality requirements
Output descriptionOutput format, confidence scores, decision thresholds

Section 3: Monitoring, Functioning, and Control

ElementDocumentation Required
Human oversight measuresArt. 14 requirements: override capability, decision review process
Technical measures for accuracyAccuracy metrics, drift detection, retraining triggers
Cybersecurity measuresData encryption, access controls, adversarial robustness testing
Performance in edge casesKnown failure modes, boundary conditions, degradation behavior

Section 4: Risk Management

ElementDocumentation Required
Risk management systemArt. 9 risk management process documentation
Known and foreseeable risksRisk register with severity and likelihood
Mitigation measuresControls for each identified risk
Residual risk assessmentAcceptable residual risk justification

Risk Management System (Art. 9)

Continuous Risk Management Process for Cerebrum AI Labs

PhaseActivityFrequency
IdentificationIdentify risks to health, safety, and fundamental rightsInitial + quarterly
AnalysisEstimate risk severity and likelihoodInitial + quarterly
EvaluationCompare risks against acceptance criteriaInitial + quarterly
MitigationImplement risk reduction measuresOngoing
MonitoringTrack risk indicators in productionContinuous
ReviewReview and update risk assessmentQuarterly

Risk Register — CV Screening AI

Risk IDRisk DescriptionSeverityLikelihoodMitigationResidual Risk
R-001Gender bias in screening recommendationsHighMediumBias testing on protected attributes, debiasing training dataLow
R-002Discrimination against non-native language speakersHighMediumMultilingual evaluation, language-agnostic featuresMedium
R-003Over-reliance on AI recommendations by recruitersMediumHighMandatory human review, confidence thresholdsLow
R-004Inaccurate qualification matching for novel job rolesMediumMediumFallback to keyword matching, human review flagLow
R-005Privacy breach via training data memorizationHighLowDifferential privacy in training, memorization auditLow

Data Governance (Art. 10)

Training Data Requirements

RequirementImplementation at Cerebrum AI Labs
Relevance and representativenessTraining data sourced from 50,000 job applications across 12 EU countries, balanced by gender, age, nationality
Bias examinationStatistical parity analysis on protected attributes (gender, age, ethnicity, disability) before and after training
Gap identificationIdentified underrepresentation of applicants with disabilities; augmented with synthetic examples
Data qualityAutomated data quality checks: completeness >95%, label accuracy >98% (human-verified sample)
Personal data processingDPIA completed (DPIA-AI-2026-001); lawful basis: Art. 6(1)(f) legitimate interest; special categories removed

Conformity Assessment (Art. 43)

Assessment Procedure for Cerebrum AI Labs

SystemAssessment TypeBasis
CV Screening AIInternal conformity assessment (Art. 43(2)) + quality management systemAnnex III, para. 4 — not biometric, not critical infrastructure
Credit Scoring AIInternal conformity assessment (Art. 43(2))Annex III, para. 5
Facial Verification AIThird-party conformity assessment (Art. 43(1)) via notified bodyAnnex III, para. 1 — biometric identification

Internal Conformity Assessment Steps

  1. Verify quality management system is established (Art. 17)
  2. Prepare technical documentation per Annex IV
  3. Conduct risk management assessment per Art. 9
  4. Verify data governance per Art. 10
  5. Verify transparency and information provision per Art. 13
  6. Verify human oversight per Art. 14
  7. Verify accuracy, robustness, and cybersecurity per Art. 15
  8. Draw up EU Declaration of Conformity (Art. 47)
  9. Affix CE marking (Art. 48)
  10. Register in EU database (Art. 49)

Post-Market Monitoring (Art. 72)

ActivityFrequencyOwner
Performance metric monitoringContinuousML Engineering
Bias drift detectionWeeklyResponsible AI team
Incident reportingAs needed (within 15 days for serious incidents per Art. 73)DPO + Legal
User feedback collectionContinuousProduct team
Risk register updateQuarterlyRisk Management
Technical documentation updateOn material changeML Engineering + Legal

Key Legal References

  • EU AI Act (Regulation 2024/1689) — Full text, entered into force 1 August 2024
  • AI Act Art. 6 + Annex III — High-risk classification criteria
  • AI Act Art. 9 — Risk management system requirements
  • AI Act Art. 10 — Data and data governance requirements
  • AI Act Art. 11 + Annex IV — Technical documentation requirements
  • AI Act Art. 13 — Transparency and provision of information to deployers
  • AI Act Art. 14 — Human oversight requirements
  • AI Act Art. 43 — Conformity assessment procedures
  • AI Act Art. 72 — Post-market monitoring obligations
  • AI Act Art. 73 — Reporting of serious incidents
  • GDPR Art. 22 — Automated individual decision-making (complementary to AI Act)
  • EDPB-EDPS Joint Opinion 5/2021 on the AI Act Proposal — Data protection perspective on AI regulation

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