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AI & Regulatory ComplianceReg. (EU) 2024/1689

EU AI Act — Annex IV Technical Documentation

Complete technical documentation for high-risk AI systems. Drafted directly from Articles 9 through 15, structured for the auditor or notified body that will read it.

Standard delivery

15 business days

Starting from

$1,200

Regulatory basis

Annex IV / Art. 9–15

Risk tier coverage

High-Risk AI

The Regulatory Context

What Annex IV actually requires providers to document.

Article 11 of Regulation (EU) 2024/1689 mandates that providers of high-risk AI systems compile and maintain technical documentation as specified in Annex IV before placing the system on the market or putting it into service.

Failure to maintain Annex IV documentation is a market access violation under Article 99 with penalties of up to €15M or 3% of global annual turnover.
Read Regulation (EU) 2024/1689

Full Article Coverage

Article 9

Risk Management System

A systematic, iterative risk identification and mitigation framework documenting probability matrices, residual safety levels, and post-deployment monitoring triggers.

Article 10

Data Governance & Provenance Log

Full data lifecycle records covering training data origins, bias mitigation measures, data quality indicators, and validation set construction.

Article 11

Technical File Assembly

Annex IV structural documentation compiling all required technical components into a single inspection-ready file meeting the provider's technical documentation obligation.

Article 12

Logging & Record-Keeping Configuration

Automated logging strategy documentation covering events capture scope, retention policy, and incident trace requirements for market surveillance.

Article 13

Transparency & User Information

End-user disclosure documentation including system capability statements, limitations disclosures, and Article 13 obligation compliance briefs.

Article 14

Human Oversight Operational Guide

Documented human oversight architecture mapping decision points, override mechanisms, and roles responsible for AI system monitoring.

Article 15

Accuracy, Robustness & Cybersecurity

Performance validation records, adversarial robustness test summaries, and security boundary documentation aligned to the system's operational context.

Pricing

Fixed-scope packages.
No surprise invoices.

Basic

Sections 1–2 only

$650per system
  • Annex IV Sections 1 and 2
  • System description and general documentation
  • Design specification summary
Most Requested

Standard

Full Annex IV

$1,200per system
  • Complete Annex IV technical file
  • Article 9 Risk Management System
  • Article 10 Data Governance log
  • Article 14 Human Oversight guide
  • 15 business-day delivery

Premium

Full provider package

$2,200per system
  • Everything in Standard
  • Article 12 logging configuration
  • Article 15 robustness documentation
  • Post-market monitoring plan (Article 61)
  • Quality Management System (Article 17)
  • 21 business-day delivery

Common Questions

Does ComplDoc certify compliance with the EU AI Act?

No. ComplDoc drafts technical evidence files that your system requires under Article 11 and Annex IV. Formal conformity assessment is conducted by a notified body or through self-assessment — ComplDoc is not a notified body and does not certify compliance.

Which AI systems require Annex IV documentation?

High-risk AI systems as defined under Annex III of Regulation (EU) 2024/1689 require Annex IV technical documentation before being placed on the market or put into service. This includes AI systems in areas like employment screening, credit scoring, biometric identification, medical devices, and critical infrastructure.

Can you work with our internal engineering team?

Yes. We coordinate directly with your ML engineers, data scientists, and product leads to extract the technical parameters required. We operate under a mutual NDA and require access to model cards, training data documentation, and system architecture briefs.

What if our system changes post-delivery?

Substantial modifications to a high-risk AI system may trigger re-documentation obligations under Article 9. We offer a Compliance Maintenance Plan for systems undergoing continuous retraining or architectural updates.

Start with a classification call.

A 60-minute session confirms whether your system falls under Annex III before any documentation work begins.