Article 11 of Regulation (EU) 2024/1689 requires every high-risk AI provider to draw up technical documentation before placing the system on the market and to keep it up to date. The minimum content is set in Annex IV: 9 blocks, ranging from general description to post-market monitoring plan. The documentation must demonstrate compliance with Chapter III, Section 2 (Articles 8 to 15) and be clear enough for national competent authorities and notified bodies to assess. SMEs and start-ups may submit Annex IV information in a simplified form (Art. 11(1)). The documentation must be retained for 10 years after placing on the market under Art. 18(1). AICheck generates the 9 Annex IV blocks in a structured ZIP in 45 minutes.
€249 one-time payment · 12 PDF documents in ZIP · 45 minutes · 100% in your browser
Annex IV is not a wishlist — it is the minimum content for the technical documentation under Art. 11(1). Each block has its own sub-items. The Commission may amend Annex IV by delegated act under Art. 11(3).
(a) intended purpose, provider name and version (and relation to previous versions); (b) interactions with hardware/software including other AI systems; (c) software/firmware versions and update requirements; (d) forms in which the system is placed on the market (embedded, downloads, APIs); (e) hardware on which it is intended to run; (f) for component-AI, photographs/illustrations of external features, marking and internal layout; (g) basic description of the user interface to deployer; (h) instructions for use for the deployer.
(a) methods and development steps, including pre-trained systems or third-party tools; (b) design specifications — general logic, key design choices, classification choices, optimisation targets, expected output and quality, technical trade-offs; (c) system architecture and computational resources used to develop, train, test, validate; (d) data requirements — datasheets describing training methodologies and data sets, provenance, scope, characteristics, selection, labelling, cleaning; (e) human-oversight measures under Art. 14; (f) pre-determined changes and the technical solutions adopted to ensure continuous compliance with Section 2; (g) validation and testing procedures, metrics for accuracy and robustness, test logs and reports; (h) cybersecurity measures.
Capabilities and limitations in performance — accuracy for specific persons/groups and overall expected accuracy in relation to intended purpose; foreseeable unintended outcomes and sources of risk to health, safety, fundamental rights and discrimination; human-oversight measures including technical measures to facilitate interpretation of outputs; specifications on input data, as appropriate.
Description of the appropriateness of the chosen performance metrics for the specific AI system, given its intended purpose and the populations on which it is to be used.
Detailed description of the risk management system implemented under Art. 9 — iterative process, risk identification, estimation/evaluation of risks, adoption of risk management measures, testing.
Description of relevant changes made by the provider to the system through its lifecycle.
List of harmonised standards applied in full or in part — references published in the Official Journal. Where no harmonised standards applied, detailed description of the solutions adopted to meet Section 2 requirements, including other relevant standards and technical specifications applied.
A copy of the EU declaration of conformity under Art. 47 and Annex V — signed, identifying the provider, the system, the Section 2 requirements, the harmonised standards applied, and any notified-body involvement.
Detailed description of the system in place to evaluate the AI system performance in the post-market phase under Art. 72, including the post-market monitoring plan referred to in Art. 72(3). The Commission implementing act with the post-market monitoring plan template is due by 2 February 2026.
Annex IV requires 9 distinct blocks, each with its own sub-items. A free-form description does not satisfy the requirement to demonstrate compliance with Section 2 in a clear and comprehensive form (Art. 11(1)). Authorities and notified bodies use the Annex IV structure as a checklist; missing blocks (training data details, performance metrics, harmonised standards, post-market plan) are common reasons for a finding of non-conformity.
No. SMEs and start-ups may submit the Annex IV information in a simplified manner under Art. 11(1), using the Commission's simplified form. Notified bodies must accept the simplified form for conformity assessment. But the substantive obligation to provide all 9 blocks of information remains.
Art. 11(1) — the technical documentation "shall be drawn up before that system is placed on the market or put into service and shall be kept up-to-date". The documentation must be retained for 10 years after placing on the market or putting into service (Art. 18(1)). Substantial modifications under Art. 3(23) require updating Annex IV and may trigger a new conformity assessment under Art. 43(4).
Answer these four questions to determine your obligations.
12 PDF documents generated from your inputs. Each cites the article of Regulation (EU) 2024/1689 it fulfils.
Identifies whether your system is prohibited (Art. 5), high-risk (Art. 6 + Annex III) or subject to transparency obligations (Art. 50).
The 9 blocks of Annex IV in full: system description, training data, validation, performance metrics, risk management, human oversight. Art. 11 + Annex IV.
Signable document conforming to Art. 47 and Annex V.
Key application dates: 2 Feb 2025, 2 Aug 2025, 2 Aug 2026, 2 Aug 2027. Art. 113.
Executive summary of compliance status for authorities or commercial buyers. Art. 43 procedure.
QMS structure covering the 13 aspects required by Art. 17.
Document for the entity deploying your system, conforming to Art. 13.
Verifiable evidence list, cross-referenced to every Annex IV block.
Notification protocol conforming to Art. 73 (15 days general / 10 days death / 2 days widespread).
Training plan conforming to Art. 4, in force since 2 February 2025.
Plan structure required by Art. 72 and integrated into the technical documentation under Annex IV(9).
Template under Art. 27 for public bodies, private entities providing public services, and Annex III 5(b)(c) deployers.
See before you buy — Download a sample dossier (PDF, fictional company) — Real structure, real articles, real format. Fictional data.
Generated from your inputs, in your browser. No data leaves your machine.
12 documents. 45 minutes. €249. The documentation your system needs before being placed on the market.
If your system falls under Art. 43(1) (Annex III point 1 biometrics with notified-body route, or Annex I products), you will need third-party conformity assessment. That is a separate process. AICheck does not replace it.
We do not sell audits. We do not sell consultancy. We sell the tool that structures your documentation under Annex IV.
Article 99 of Regulation (EU) 2024/1689. Chapter XII (Penalties) applies from 2 August 2025.
Art. 99(3). Up to €35 million or 7% of total worldwide annual turnover, whichever is higher. For SMEs and start-ups: whichever is lower (Art. 99(6)).
Art. 99(4). Includes failure to draw up technical documentation under Art. 11 + Annex IV. Covers obligations of providers (Art. 16), deployers (Art. 26), authorised representatives (Art. 22), importers (Art. 23), distributors (Art. 24), notified bodies (Art. 31, 33, 34) and transparency under Art. 50.
Art. 99(5). Applies when information provided to notified bodies or national competent authorities is wrong or misleading.
If you operate multiple AI systems and need to document them all under Annex IV, contact us for volume pricing at hello@solidwaretools.com.
Request volume pricingAICheck produces a document structured under Article 11 and Annex IV of Regulation (EU) 2024/1689 from the information you provide. The accuracy, truthfulness and completeness of that information is your responsibility as provider of the AI system.
We guarantee that the document structure follows Article 11 and Annex IV of Regulation (EU) 2024/1689 and that the legal references cited are correct as of the last verification date. We do not guarantee that a specific document will be accepted by a market surveillance authority in a given case, nor by a commercial buyer in a procurement process.
AICheck is not legal advice. For specific situations, consult a lawyer or specialised regulatory consultancy.
Twelve documents. Annex IV fully structured. Regulation (EU) 2024/1689. Your data does not leave your machine. The ZIP you download is yours to keep.