Intermediate2h 19m

# EU CE Marking for High-Risk AI Systems | EU AI Act

The complete first-principles-to-practical guide to CE marking a high-risk AI system under the EU AI Act — classification, conformity assessment, technical documentation, and the declaration of conformity, built on the finalised Digital Omnibus timeline.

Most teams building AI-driven products discover 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. CE marking an AI system isn't a paperwork afterthought bolted onto a CE-marked product — for a genuinely high-risk system, it's a structured legal process with its own classification test, its own conformity assessment routes, and its own declaration of conformity, layered on top of whatever product law already applied. This course teaches Regulation (EU) 2024/1689 from first principles to complete practical compliance, built specifically around CE marking mechanics rather than general awareness. You'll learn the exact two-part classification test in Article 6 — the Annex I safety-component pathway and the Annex III use-case pathway — and how to apply the narrow Article 6(3) exemption without talking yourself into an exemption that won't survive a market surveillance review. You'll go through all eight Annex III high-risk categories and the Annex I sectoral list in detail, the prohibited practices in Article 5 that make certain systems unbuildable in the EU regardless of documentation, and the full obligations map across providers, deployers, importers, distributors, and authorised representatives. From there, the course goes deep on the parts that actually determine whether your CE mark is defensible: the risk management system under Article 9, technical documentation under Annex IV, the conformity assessment procedure under Article 43 — including exactly when a notified body has to be involved and when it doesn't — the EU declaration of conformity under Article 47, and how to physically and digitally affix the CE mark itself under Article 48. Every module accounts for the Digital Omnibus amendments the Council finally adopted in mid-2026, which pushed the Annex III high-risk compliance date to 2 December 2027 and the Annex I date to 2 August 2028 — and for the fact that, as of this course's production, no harmonised standard supporting the AI Act has yet been cited in the Official Journal, which means "get ISO/IEC 42001 certified and you're covered" is not currently true, and this course teaches you what to do instead. The closing stretch walks a complete worked example — a recruitment-screening AI vendor's system moving from first classification through conformity assessment to a filed declaration of conformity — and turns everything into your own sequenced compliance action plan. Built on Krono's regulatory database and current 2026 guidance on the Digital Omnibus deadline changes, the state of AI Act harmonised standards, and market surveillance authority practice for classification and conformity assessment. This course contains the use of artificial intelligence for asthetic purposes.

*   Includes the ebook edition, free
*   9 downloadable resources included

## What you'll learn

*   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

## Requirements

*   ·No prior EU regulatory or legal background required — the course starts from first principles
*   ·Some familiarity with how your organisation builds or deploys AI systems is helpful but not essential
*   ·AI product managers, ML engineers, compliance leads, and legal/regulatory teams will all benefit

$199.00

One-time purchase · Lifetime access · No subscription

Less than one hour with a compliance consultant.

[First lesson free to preview: EU CE Marking for High-Risk AI Systems: The Complete Course](#lesson-5146826d-8ddc-4d8a-b2e0-4223bd69c428)

*   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

Includes the ebook edition, free — read it in your [library](/profile/books) after purchase.

Enroll — $199.00

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## Course content

155 lessons·1555 min total

The Big Picture

10 lessons · 71 min

*   EU CE Marking for High-Risk AI Systems: The Complete Course
    
    Preview7:05
    
*   The Real Cost of Getting This Wrong
    
    7:05
    
*   What CE Marking Actually Means for an AI System
    
    7:05
    
*   Who This Course Is Built For
    
    7:05
    
*   What You'll Be Able to Do by the End
    
    7:05
    
*   The Compliance Timeline Just Moved
    
    7:05
    
*   How This Course Is Structured
    
    7:05
    
*   What 'Premium' Means in This Course
    
    7:05
    
*   What This Course Does Not Cover
    
    7:05
    
*   Knowledge Check — The Big Picture
    
    7:05
    

Legal Foundations of the EU AI Act

11 lessons · 109 min

Classification: Is Your System High-Risk?

12 lessons · 128 min

Annex III — The Eight High-Risk Categories

14 lessons · 180 min

Annex I — AI as a Safety Component

10 lessons · 96 min

Prohibited Practices: What's Off the Table Entirely

12 lessons · 131 min

Roles and Responsibilities Across the AI Value Chain

10 lessons · 86 min

Building the Risk Management System

10 lessons · 89 min

Transparency, Human Oversight, Accuracy, and Robustness

11 lessons · 111 min

Conformity Assessment and CE Marking Mechanics

14 lessons · 189 min

Quality Management and Post-Market Obligations

10 lessons · 87 min

Deployer Obligations and Fundamental Rights Impact Assessments

11 lessons · 116 min

Penalties, Enforcement, and the Real Compliance Timeline

9 lessons · 77 min

Wrap-Up: The Complete Worked Example and Your Action Plan

10 lessons · 85 min

What's Next

1 lessons · 0 min

Enroll — $199.00