Technical Documentation: What It Means Under the EU AI Act

Under the EU AI Act, technical documentation is the file the provider of a high-risk AI system must draw up before the system reaches the market and keep current for its working life. It is the evidence base that proves conformity — not a marketing pack, not a user manual, not a runtime log. This page pins down what the file is and routes the Annex IV breakdown and the fill-in template to dedicated pages below.

---

The EU AI Act definition

Article 11(1) of Regulation (EU) 2024/1689 sets the obligation in one move: the provider of a high-risk AI system must draw up the technical documentation before the system is placed on the market or put into service, and keep it up to date.

The statute fixes the purpose. The file must demonstrate that the system complies with the requirements in Chapter III, Section 2 (Articles 8 to 15) — risk management, data governance, record-keeping, transparency, human oversight, accuracy, robustness and cybersecurity — in a clear and comprehensive form, so national competent authorities and notified bodies can assess that compliance.

The minimum contents are set by Annex IV. Article 11(1) requires the file to contain at least the elements Annex IV lists — a floor, not a ceiling.

A scope guardrail. A stand-alone Annex III high-risk system takes this duty directly. For a high-risk system tied to a product under the Annex I Section A acts — machinery, medical devices under MDR 2017/745, in-vitro diagnostics under IVDR 2017/746 — Article 11(2) lets a single set of documentation satisfy both this Regulation and the sectoral act, and Article 43(3) routes conformity through those acts.

---

What the file must contain (Annex IV, in brief)

Annex IV sets the minimum content categories. A glossary lists those categories; it does not reproduce the form.

Why a glossary lists the categories, not the form

The categories tell you what the file covers. The drafting itself belongs on the deep-dive and template pages linked below. Here is the map.

Article 11(1) frames these as the minimum: authorities may require additional information to assess conformity. For the section-by-section drafting and a fill-in structure, follow the Annex IV deep-dive and the template page in the related terms below.

---

The simplified form for small companies and start-ups

The final subparagraph of Article 11(1) eases the presentation burden, not the substance. SMEs, including start-ups, may provide the Annex IV elements in a simplified manner. The Commission is to establish a simplified technical documentation form for small enterprises; a small company relying on it provides the elements that form specifies.

Simplified does not mean exempt. The same conformity with Articles 8 to 15 must still be demonstrable, and a competent authority can still request the underlying information. Only the documentation effort is lightened.

---

How it differs from the declaration of conformity and the logs

Three instruments get confused. They are distinct in what they are, which article governs them, and the role each plays.

Technical documentation vs EU declaration of conformity (Article 47)

The EU declaration of conformity under Article 47 is a short signed attestation that the system meets Articles 8 to 15; its contents come from Annex V. A copy of it is itself one Annex IV element. The technical documentation is the evidence base it points to — the declaration is the cover page, the documentation is the file behind it.

Technical documentation vs automatically generated logs (Articles 12 and 19)

Article 12 requires high-risk systems to technically allow the automatic recording of events — logs — over their lifetime. Article 19 requires the provider to keep those logs for at least six months unless other law requires longer. Logs are runtime records the system generates as it runs; technical documentation is a static file drawn up before market entry. One records what happened; the other explains how the system was built and why it conforms.

Who draws it up. Only the provider; Article 16(c) lists keeping the technical documentation among provider obligations. Under Article 25, a deployer, distributor or importer becomes a provider — and inherits this duty — where it puts its name or trademark on the system, makes a substantial modification, or changes the intended purpose so the system becomes high-risk.

Retention. Under Article 18, the provider keeps the technical documentation at the disposal of national competent authorities for 10 years after the system is placed on the market.

---

How Confir helps

Confir assembles the Annex IV technical documentation from the conformity record you have already built, mapping each point to the underlying evidence and flagging gaps before market entry. The synthesis engine is deterministic and rule-based — no model inference, no hallucination — so the file reflects your record exactly.

---

Frequently asked questions

What is technical documentation under the EU AI Act?

It is the file the provider of a high-risk AI system must draw up before the system is placed on the market or put into service, then keep up to date (Article 11(1)). Its job is to demonstrate that the system meets the Chapter III, Section 2 requirements (Articles 8 to 15) and to give national competent authorities and notified bodies the information they need to assess that compliance. Article 11 sets the obligation; Annex IV fixes the minimum contents the file must include.

Is technical documentation the same as the declaration of conformity?

No. The technical documentation (Article 11, Annex IV) is the detailed evidence base that demonstrates conformity. The EU declaration of conformity (Article 47, Annex V) is a short signed statement that the system meets Articles 8 to 15. They are linked but distinct: a copy of the declaration is itself one of the Annex IV elements the technical documentation must contain. The declaration is the cover attestation; the technical documentation is the file it points to.

How is technical documentation different from the AI system's logs?

Technical documentation is a static file the provider draws up before market entry and keeps current (Article 11). Logs are runtime records: Article 12 requires high-risk systems to technically allow the automatic recording of events over their lifetime, and Article 19 requires the provider to keep those logs for at least six months unless other law requires longer. Documentation describes how the system was built and why it conforms; logs record what it actually did in operation.

Can small companies use a simplified technical documentation file?

Yes. The final subparagraph of Article 11(1) lets SMEs, including start-ups, provide the Annex IV elements in a simplified manner, using a simplified form the Commission is to establish for small enterprises. Simplified presentation does not remove the duty: the same conformity with Articles 8 to 15 must still be demonstrable, and authorities can still request the underlying information. Only the documentation burden is eased, not the substantive requirement.

Who has to draw up the technical documentation, and how long must it be kept?

Only the provider — the entity placing the high-risk AI system on the market or putting it into service under its own name or trademark (Article 16(c)). Under Article 25, a deployer, distributor or importer that rebrands the system, substantially modifies it, or changes its intended purpose to a high-risk use is treated as a provider and inherits the duty. The provider must keep the documentation at the disposal of national competent authorities for 10 years after the system is placed on the market or put into service (Article 18).

---

Related terms

• Article 11 technical documentation obligation
• Annex IV technical documentation contents
• Annex IV technical documentation template
• EU declaration of conformity
• build and maintain AI documentation