EU AI Act High-Risk Technical Documentation Generator

General Description, Intended Purpose, and Provider

Identify the high-risk AI system, its provider, intended purpose, users, and operating context.

AI system name

Provider legal name

Provider address

Compliance contact

Intended purpose Required. Describe what the system is designed to do, the decision context, and the expected users.

High-risk category

User groups

Deployment context and operating assumptions

System Elements and Development Process

Document components, development lifecycle, third-party tools or models, logging, and technical environment.

System architecture and components

Development process

AI models and model versions

Third-party tools, APIs, or models

Compute and deployment environment

Logging and traceability capabilities

Data and Data Governance

Record training, validation, and test data; provenance; quality controls; representativeness; and bias checks.

Data governance summary Required. Summarize the governance system for datasets used by the AI system.

Training data

Validation data

Test data

Data provenance and collection

Quality and representativeness checks

Bias checks and remediation

Preprocessing and feature controls

Retention, deletion, and access controls

Monitoring, Functioning, and Control

Describe accuracy, robustness, cybersecurity, human oversight, monitoring, fallback, and incident handling.

Accuracy metrics and thresholds

Robustness metrics and stress tests

Cybersecurity measures

Human oversight measures

Runtime monitoring process

Incident response and escalation

Fallback, shutdown, or safe-use controls

Risk-Management System

Maintain a risk register with hazards, mitigations, residual risk, owners, and review status.

Risk-management process

Changes and Version History

Track material changes, technical impacts, and approvals across the system lifecycle.

Change-control process

Standards Applied and EU Declaration of Conformity

Capture harmonised standards, common specifications, conformity assessment, and EU DoC references.

Harmonised standards applied

Common specifications or other controls

Conformity assessment approach

EU Declaration of Conformity reference

Quality management system reference

Notified body or internal assessment notes

Post-Market Monitoring Plan

Define post-market monitoring, feedback channels, performance reviews, incident reporting, and corrective actions.

Post-market monitoring plan

Feedback and complaint channels

Performance review cadence

Serious incident reporting process

Corrective and preventive actions

Record keeping and evidence retention

JSON Output

Portable client-side export generated from the same Annex IV data model as the dossier.

Current JSON

About the EU AI Act High-Risk Technical Documentation (Annex IV)

Providers of high-risk artificial intelligence systems must maintain exhaustive technical records detailing their model's architecture, training data, and safety guardrails. Formatting an Annex IV technical documentation dossier prevents deployment delays and demonstrates rigorous algorithmic accountability to EU notified bodies. AI engineers can systematically outline risk management frameworks, data governance procedures, and robust human oversight mechanisms into a single, compliant file.

How it works

Describe the AI system's intended purpose, architecture, and logic.

Detail the data governance protocols, including the origin, scope, and preparation of training datasets.

Document the risk management system, specifying identified hazards and implemented mitigation strategies.

Compile the final technical dossier, including post-market monitoring plans and human oversight instructions.

Frequently asked questions

What qualifies an AI system as 'high-risk' under the EU AI Act?

High-risk systems include those used as safety components in regulated products (like medical devices) and specific standalone applications affecting fundamental rights, such as biometrics, critical infrastructure, employment screening, and law enforcement.

What must be included in the data governance section of the dossier?

Providers must document the design choices, data collection processes, data preparation (cleaning and labeling), and assessments for biases or gaps within the training, validation, and testing datasets.

Is a risk management system required before the AI is developed?

Yes, the risk management system must be established early in the design phase and must be an iterative, continuous process that updates throughout the entire lifecycle of the high-risk AI system.

Who reviews the Annex IV technical documentation?

The documentation must be kept at the disposal of national competent authorities for inspection, and for certain high-risk categories, it must be submitted to a designated Notified Body for an external conformity assessment before market entry.