Briefing
AI Act Instructions for Use: Article 13
The Short Answer
A Document Set the Provider Must Write and Keep Current
Regulation (EU) 2024/1689, the AI Act, requires high-risk AI systems to be accompanied by instructions for use (Article 13(2)). The Regulation defines instructions for use as the information the provider gives the deployer about, in particular, the system's intended purpose and proper use (Article 3(15)). Article 13(3) lists the minimum content. The deployer is then bound to use and monitor the system in accordance with them (Article 26).
This is a different subject from using AI on your own documents. If that is what you came for, read how an AI answers from your documents. Here the AI system is the product, and its manual is the regulated item. This article reads the provisions as a documentation team would. It is not legal advice; whether your system is high-risk, and what you owe, is a question for your legal and conformity advisers and for the text of the Regulation.
Dates
December 2027 and August 2028
Regulation (EU) 2026/1744, the Digital Omnibus on AI, was signed on 8 July 2026 and published in the Official Journal on 24 July 2026. It entered into force on the third day after publication, 27 July 2026 (Article 4). It replaced Article 113(c) of the AI Act so that Chapter III Sections 1, 2 and 3, with the exception of Article 6(5), apply from 2 December 2027 for AI systems classified as high-risk under Article 6(2) and Annex III, and from 2 August 2028 for those classified under Article 6(1) and Annex I. Article 13 sits in Section 2, so those are its dates.
Two related points. Article 111(2), as replaced, applies the Regulation to systems already on the market before the Chapter III date only if they are subject to significant changes in design, but providers and deployers of high-risk systems intended for public authorities must take the necessary steps to comply by 2 August 2030. And the same Regulation moved machinery to Section B of Annex I, which changes how AI requirements reach machinery; our comparison of EU digital instruction rules sets that out next to the other regimes.
Article 13(3)
What the Instructions Must Contain
Article 13(2) sets the standard: the information must be concise, complete, correct and clear, and relevant, accessible and comprehensible to deployers. Article 13(3) says the instructions contain at least the following.
- (a) Who the provider is
- The identity and contact details of the provider and, where applicable, of its authorized representative.
- (b) What the system can and cannot do
- The characteristics, capabilities and limitations of performance, in seven parts. (i) Its intended purpose. (ii) The accuracy, robustness and cybersecurity levels it was tested and validated against and can be expected to reach, with the metrics, and any known and foreseeable circumstances that affect them. (iii) Any known or foreseeable circumstance, in intended use or reasonably foreseeable misuse, that may lead to risks to health and safety or fundamental rights. (iv) Where applicable, the technical capabilities that help explain its output. (v) When appropriate, its performance for the specific persons or groups it is meant to be used on. (vi) When appropriate, specifications for the input data, or other relevant information on the training, validation and testing data sets. (vii) Where applicable, information that lets deployers interpret the output and use it appropriately.
- (c) Changes decided in advance
- The changes to the system and its performance that the provider pre-determined at the moment of the initial conformity assessment, if any.
- (d) Human oversight
- The human oversight measures referred to in Article 14, including the technical measures that help deployers interpret the system's outputs.
- (e) Resources, lifetime and upkeep
- The computational and hardware resources needed, the expected lifetime of the system, and any necessary maintenance and care measures, including their frequency, to ensure proper functioning, including as regards software updates.
- (f) Logs
- Where relevant, a description of the mechanisms in the system that let deployers properly collect, store and interpret the logs, in line with Article 12.
Article 15(3) adds one more placement rule: the levels of accuracy and the relevant accuracy metrics "shall be declared in the accompanying instructions of use". Several items are conditional ("where applicable", "when appropriate", "where relevant"), which means the provider decides and should be able to explain why an item was left out.
Two Documents
Instructions Are Not the Technical File
Article 11(1) requires technical documentation to be drawn up before the system is placed on the market or put into service and kept up to date. It must demonstrate compliance and give national competent authorities and notified bodies the information to assess it in a clear and comprehensive form, and it contains at a minimum the elements in Annex IV. Regulation (EU) 2026/1744 replaced the second subparagraph of Article 11(1) to extend the simplified form for Annex IV to small mid-caps as well as SMEs.
The audiences differ: authorities and notified bodies for the technical file, deployers for the instructions. They overlap in one place. Annex IV point 1(h) lists the instructions for use for the deployer among the items of the technical file, so the two documents must agree. For a high-risk system related to a product covered by the Union harmonization legislation in Section A of Annex I, Article 11(2) calls for a single set of technical documentation containing the Article 11(1) information and what those other acts require. The 10-year retention duty in Article 18(1) names the technical documentation, not the instructions for use.
Article 26
What Deployers Do With Them
- Use the system as the instructions say
- Article 26(1): deployers take appropriate technical and organizational measures to use high-risk systems in accordance with the instructions for use that accompany them.
- Monitor on the basis of the instructions
- Article 26(5): deployers monitor the operation of the system on the basis of the instructions for use. If using it in accordance with the instructions may result in a risk, they must inform the provider or distributor and the market surveillance authority without undue delay, and suspend use.
- Run human oversight
- Article 26(2): deployers assign human oversight to people with the necessary competence, training, authority and support. The oversight measures they apply are the ones the provider described under Article 13(3)(d).
- Keep the logs
- Article 26(6): deployers keep the automatically generated logs to the extent they control them, for a period appropriate to the intended purpose and at least six months, unless other law provides otherwise. Article 13(3)(f) is where they learn how to collect and interpret them.
- Feed a data protection impact assessment
- Article 26(9): where applicable, deployers use the information provided under Article 13 for their obligation to carry out a data protection impact assessment.
Each of these duties points back at the instructions, so a gap in the document becomes a gap in the customer's compliance. An instruction set that is vague about limitations or oversight leaves the deployer unable to show it followed them.
Keeping It Current
What a Provider Has to Run
Article 13(3)(c) and (e) make the instructions describe change: updates the provider pre-determined at the initial conformity assessment, and maintenance and software updates with their frequency. Article 11(1) says the technical file is kept up to date. Read together, they describe a versioned set. Each system version needs the instructions that match it, the limitations and accuracy figures that apply to that version, and a record of what changed between versions. That is a documentation-engineering reading rather than a quotation from the Regulation, and it follows the same pattern as the machinery rule's digital-instruction conditions.
Content that must stay consistent between the deployer instructions and the technical file is the case for single-source publishing: write the intended purpose, limitations and oversight measures once and publish them to both. Tying each version to its effective date is the discipline described in effective-dated publishing. For how to structure and write instructions for a defined audience, IEC/IEEE 82079-1 is the general international standard for preparing instructions for use; the Regulation does not cite it, so treat it as method. Where the system sits in a regulated machine or device, compare the electronic instructions for medical devices.
FAQ
Questions We Hear
Is this about using AI to write or search our manuals?
No. This page is about the documents a provider of a high-risk AI system must supply to the organizations that deploy it. If you want to know how AI systems answer questions from your own documents, see How an AI Answers From Your Documents. The AI Act duty here attaches to the system being sold or put into service, not to the tools used to write its manual.
What is the difference between instructions for use and technical documentation?
Instructions for use go to the deployer so it can use the system properly (Article 13). Technical documentation is drawn up to demonstrate compliance and is written for national competent authorities and notified bodies (Article 11(1)). The instructions are also one of the items listed in Annex IV point 1(h), so the technical file has to contain them. A provider keeps the technical documentation at the disposal of the authorities for 10 years after the system is placed on the market or put into service (Article 18(1)).
When do the Article 13 rules apply?
Regulation (EU) 2026/1744 replaced Article 113(c). Chapter III Sections 1 to 3, which include Article 13, apply from 2 December 2027 for systems classified as high-risk under Article 6(2) and Annex III, and from 2 August 2028 for those under Article 6(1) and Annex I. Article 111(2) separately gives providers and deployers of high-risk systems intended for public authorities until 2 August 2030 for systems already on the market.
Must the instructions be digital, or can they be on paper?
Article 13(2) says the instructions accompany the system "in an appropriate digital format or otherwise". It does not say paper must be offered on request, how long the instructions must stay available, or in which language. It requires the information to be concise, complete, correct and clear, and relevant, accessible and comprehensible to deployers. Other provisions or national law may add requirements.
Where does the accuracy level go?
Into the instructions. Article 15(3) says the levels of accuracy and the relevant accuracy metrics shall be declared in the accompanying instructions of use, and Article 13(3)(b)(ii) lists them with robustness and cybersecurity as required content.
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Plan the Document Set Before the Date
Send us the instructions or technical file you have for a system today and we will talk through how it is structured and kept current.