Annex III to Regulation (EU) 2024/1689 lists 8 domains in which AI systems are classified as high-risk under Article 6(2). Any AI system intended for use in these areas triggers the full Chapter III, Section 2 requirements — risk management (Art. 9), data governance (Art. 10), technical documentation (Art. 11 + Annex IV), record-keeping (Art. 12), transparency to deployers (Art. 13), human oversight (Art. 14), accuracy/robustness/cybersecurity (Art. 15) — plus provider obligations under Art. 16 and conformity assessment under Art. 43. The obligations apply from 2 August 2026.
€249 one-time payment · 12 PDF documents in ZIP · 45 minutes · 100% in your browser
Each domain has specific sub-items. A system that fits any sub-item is in scope. The list below is verbatim from the Annex III text of Regulation (EU) 2024/1689.
No. Art. 6(1) defines a second high-risk route: AI as a safety component of products covered by Annex I harmonisation legislation (machinery, toys, lifts, medical devices, etc.) that require third-party conformity assessment. Annex III only covers Art. 6(2). The Art. 6(1) route applies from 2 August 2027 under Art. 113(c).
Annex III 5(b) expressly excludes AI systems used for the purpose of detecting financial fraud from the credit-scoring scope. A pure fraud-detection model is NOT high-risk under 5(b). A hybrid system that performs both credit scoring AND fraud detection remains high-risk for the credit-scoring component.
Annex III 4(a) covers AI used for recruitment, selection, targeted job ads, application filtering and candidate evaluation. Size, internal-only deployment, and number of decisions made are irrelevant to classification. A small internal screening tool is high-risk if it fits 4(a).
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.