Article 43 of Regulation (EU) 2024/1689 sets the conformity-assessment procedure that every high-risk AI provider must complete before placing the system on the market. Two paths: Annex VI internal control, where the provider self-assesses; or Annex VII, where a notified body assesses the quality management system and the technical documentation. The path depends on the Annex III category. For points 2 to 8 of Annex III, only Annex VI applies. For point 1 (biometrics), the provider chooses between Annex VI (with harmonised standards) and Annex VII (with notified body). For Art. 6(1) products covered by Annex I, the sectoral conformity procedure applies. Certificates issued by notified bodies are valid for up to 4 years for Annex III systems (5 for Annex I) under Art. 44(2).
€249 one-time payment · 12 PDF documents in ZIP · 45 minutes · 100% in your browser
Article 43 distinguishes the conformity procedure by Annex III category. Most providers do not need a notified body. The 4 paths below cover every high-risk case.
False. Art. 43(2) provides that Annex III points 2 to 8 follow Annex VI internal control, with no notified-body involvement. Only Annex III point 1 (biometrics) sometimes requires Annex VII with a notified body, and Art. 6(1) systems follow the sectoral conformity procedure under the relevant Annex I act. The majority of Annex III high-risk providers self-assess under Annex VI.
Art. 44(2): certificates are valid for up to 4 years for Annex III systems and 5 years for Annex I systems. Re-assessment is required for extension. Additionally, Art. 43(4) requires a new conformity assessment on any substantial modification (Art. 3(23)). The certificate is a snapshot — the obligation is continuous.
Art. 17(4) lets financial institutions reuse their existing internal-governance arrangements for points (g), (h) and (i) of the Art. 17 QMS — but only those three points, not the full QMS, and not the Art. 43 conformity-assessment procedure itself. Art. 72(4) similarly allows financial institutions to integrate the post-market monitoring obligations into their existing systems. The conformity-assessment obligation under Art. 43 stands.
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.