The EU AI Act Conformity File Engine assembles a regulator-ready technical file — Annex IV technical documentation, Article 9 risk-management file, data-governance record, post-market monitoring plan, and a draft EU Declaration of Conformity — checked against the letter of the AI Act before a qualified reviewer releases it.
An AI provider's conformity assessment is only as strong as the technical file behind it. Miss one of the nine Annex IV sections, skip a required risk-management step, misclassify the system, or fail to document data governance — and the provider faces administrative fines up to €15M or 3% of worldwide annual turnover.
Most providers run this by hand, from memory, once or twice before a deadline. The Act has not been read end-to-end since the last time it mattered. That is exactly where completeness gaps hide.
The EU AI Act Conformity File Engine exists to close that gap with a single, exhaustive standard applied identically to every file.
We do not summarize the law and hope. Every file is scored against a versioned rule pack tied to the exact text of Regulation (EU) 2024/1689. These are the provisions each file is held to.
General description, development methodology, system architecture, training data, performance metrics, risk management, data governance, transparency, and human oversight — all present, or the file does not release.
A documented risk-management process covering identification, analysis, evaluation, mitigation, and residual risk acceptance — mapped to the system's intended purpose and reasonably foreseeable misuse.
Training, validation, and testing data provenance, bias detection, and suitability assessment — including data collection, labeling, and preprocessing practices.
For most Annex III high-risk systems, the provider self-assesses. The file must demonstrate compliance with Articles 9–15 and Annex IV — no notified body required.
A systematic plan to collect, document, and analyze data on system performance and incidents throughout the lifetime of the system.
A draft Declaration of Conformity referencing the relevant harmonized standards, and a CE-marking checklist — sequenced so the provider can affix the mark and register in the EU database.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A qualified AI-governance reviewer signs every release. That order is never reversed.
Upload system artifacts (model cards, datasheets, evaluation reports, architecture docs). We return a free completeness read: which Annex IV sections and Act requirements you already have, and which are missing.
We classify the system under Annex III (high-risk, limited, minimal, or GPAI) and map each Act requirement to existing evidence — flagging gaps for drafting.
The nine Annex IV sections are drafted from your validated artifacts and the AI Act rule pack into field-locked templates — no legal opinions, no invented facts.
Every article and annex requirement is checked; risk management is verified; data governance is resolved; post-market monitoring plan is present. Any failure blocks release.
A qualified AI-governance reviewer reviews the exception queue and attests that the file is complete and internally consistent. High-risk or GPAI systems route to attorney review first.
You receive the file: Annex IV technical documentation, risk-management file, data-governance record, post-market monitoring plan, draft Declaration of Conformity, and a gap-remediation plan — ready for the provider to sign and self-declare.
The deliverable is completeness itself — every article and annex requirement accounted for or explicitly exception-coded. Nothing is left implicit.
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a statutory requirement.
We prepare documentation and run evidence mapping as your clerical agent. We never provide legal advice, classify systems as high-risk, or sign the Declaration of Conformity.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
Start with a free System Gap Scan. Send your system artifacts and we'll return a completeness read against every article and annex of the AI Act.
Documentation-completeness service · not legal advice · the provider signs every declaration.