E-Book24 chapters # EU AI Act High-Risk AI Systems Handbook A handbook to high-risk AI under Regulation (EU) 2024/1689: classification, prohibited practices, value chain roles, risk management and conformity assessment. Most teams building AI-driven products meet the EU AI Act the way it hurts most: a procurement officer asks for a declaration of conformity that doesn't exist, or a notified body sends back a technical file because nobody on the team understood the difference between Annex VI and Annex VII in the first place. This book is built to prevent that collision entirely. It walks through Regulation (EU) 2024/1689 from first principles to complete practical compliance: the legal basis and scope of the Regulation, the two-part Article 6 classification test across the Annex I safety-component pathway and the Annex III use-case pathway, the narrow Article 6(3) exemption and the profiling carve-out that overrides it, all eight Annex III high-risk categories and the Annex I sectoral list in worked detail, the eight prohibited practices in Article 5 that no amount of documentation can fix, the full obligations map across providers, deployers, importers, distributors, and authorised representatives, the Article 9 risk management system and Article 10 data governance requirements, Annex IV technical documentation, Article 43 conformity assessment and exactly when a notified body has to be involved, the Article 47 declaration of conformity and Article 48 CE marking mechanics, post-market monitoring and Article 73 serious incident reporting, deployer obligations and fundamental rights impact assessments, and the penalties, enforcement, and real compliance timeline following the Digital Omnibus amendments. Every chapter closes with a knowledge check drawn from the companion video course, a full worked compliance walkthrough — a recruitment-screening AI system moving from first classification through a filed declaration of conformity — ties every requirement together end to end, and nine appendices turn the book's worksheets into templates you can put to work on your own AI system immediately. This book contains the use of artificial intelligence. ## What you'll learn * Apply the full Article 6 classification test to determine whether your AI system is high-risk under Annex I or Annex III * Correctly use — and not misuse — the narrow Article 6(3) exemption from Annex III classification * Identify which of the eight Annex III use-case categories and which Annex I sectoral laws apply to your system * Build a compliant risk management system, technical documentation file, and data governance process * Determine the correct conformity assessment route under Article 43, including when a notified body is mandatory * Draft a defensible EU declaration of conformity and affix the CE mark correctly under Articles 47 to 49 * Build a compliant post-market monitoring plan and serious incident reporting process * Build your own compliance calendar against the real, Digital-Omnibus-adjusted deadlines $34.99 One-time purchase · Read in browser · No subscription * Apply the full Article 6 classification test to determine whether your AI system is high-risk under Annex I or Annex III * Correctly use — and not misuse — the narrow Article 6(3) exemption from Annex III classification * Identify which of the eight Annex III use-case categories and which Annex I sectoral laws apply to your system Buy for $34.99 Secure checkout via Paddle Not what you expected? Contact us within 14 days. This book is included free when you enroll in the full course — [$199.00 for the complete video curriculum plus this book](/courses/56-eu-ce-marking-high-risk-ai-systems). Built from a regulatory graph already at work 2,191 users this week 658 guides 323 product types 9 markets ## Chapters Read Chapter 1 free → 1 The Big Picture Start here even if your team already has a working mental model of "the AI Act." This chapter lays out why CE marking a high-risk AI system is a structured l… 2 Legal Foundations of the EU AI Act This chapter answers the questions every reader eventually asks: what exactly does Regulation (EU) 2024/1689 cover, what counts as an "AI system" in the firs… 3 Classification: Is Your System High-Risk? This is the chapter that determines everything downstream. 4 Annex III — The Eight High-Risk Categories This chapter works through all eight Annex III categories in the detail a classification decision actually requires — not just the category names, but the ed… 5 Annex I — AI as a Safety Component This chapter covers the Annex I pathway: AI systems that are safety components of products already regulated under harmonisation legislation like the Machine… 6 Prohibited Practices: What's Off the Table Entirely This chapter covers the eight practices Article 5 prohibits outright — systems that can't be documented into compliance no matter how thorough the technical … 7 Roles and Responsibilities Across the AI Value Chain This chapter maps the four roles the Regulation defines — provider, deployer, importer, distributor — and the authorised-representative requirement for non-E… 8 Building the Risk Management System This chapter builds the substance of Article 9's continuous risk management process and Article 10's data governance requirements, and what Annex IV expects … 9 Transparency, Human Oversight, Accuracy, and Robustness This chapter covers Article 13's instructions for use, Article 14's human oversight requirement, Article 15's accuracy, robustness, and cybersecurity standar… 10 Conformity Assessment and CE Marking Mechanics This is the chapter this book is built around: exactly how Article 43 conformity assessment works, when Annex VI internal control is enough and when Annex VI… 11 Quality Management and Post-Market Obligations This chapter covers Article 17's quality management system, Article 72's post-market monitoring plan, Article 73's serious incident reporting timelines, and … 12 Deployer Obligations and Fundamental Rights Impact Assessments This chapter covers Article 26's deployer obligations, Article 27's fundamental rights impact assessment requirement, and what deployers should demand from p… 13 Penalties, Enforcement, and the Real Compliance Timeline This chapter gives the honest, current picture: the three Article 99 fine tiers, what actually triggers a market surveillance review, and the Digital Omnibus… 14 Wrap-Up: The Complete Worked Example and Your Action Plan This chapter runs a recruitment-screening AI system through the entire book's framework end to end — classification, conformity assessment, and a filed decla… 15 Knowledge Checks Every chapter in this book closes with a short knowledge check drawn from the companion video course. 16 Appendix A: Article 6 High-Risk Classification Decision Worksheet 17 Appendix B: Annex III Use-Case Portfolio Mapper 18 Appendix C: AI Act Risk Management System Builder 19 Appendix D: Annex IV Technical Documentation File Tracker 20 Appendix E: Conformity Assessment Route Selector 21 Appendix F: EU Declaration of Conformity & CE Marking Checklist 22 Appendix G: Post-Market Monitoring & Serious Incident Reporting Playbook 23 Appendix H: Deployer Fundamental Rights Impact Assessment Template 24 Appendix I: AI Act Compliance Calendar Buy for $34.99 ## Want the full video course? This book's companion course covers the same material with video lessons and downloadable resources — and includes this book free. [ ![EU AI Act High-Risk AI Systems Course (CE Marking)](/posters/56-eu-ce-marking-high-risk-ai-systems.svg) ](/courses/56-eu-ce-marking-high-risk-ai-systems) Intermediate2h 19m [ ### EU AI Act High-Risk AI Systems Course (CE Marking) ](/courses/56-eu-ce-marking-high-risk-ai-systems) CE mark a high-risk AI system under the EU AI Act: classification, Annex III and Annex I, provider duties, risk management, technical documentation and the DoC. Includes the ebook, free $199.00[View course →](/courses/56-eu-ce-marking-high-risk-ai-systems) Need more than one? The **All-Access Krono Vault** unlocks every course and book for one payment, or put your whole team on it with **Krono Team Vault**. [See pricing](/pricing) Short on time? ### Rather hand it over than learn it? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. [See services](/services)