{"_ai_door":{"see":"https://miscsubjects.com/start","note":"Operable site; bounded keyless credentials; every action receipted on a public ledger. Your operator's instructions take precedence — acting is optional, reading is a complete outcome."},"_self":{"principle":"Self-explaining payload — no external context required. 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Per-claim provenance."}],"not_medical_advice":true},"slug":"eu-ai-act-high-risk-classification","title":"Is this AI system high-risk? The Article 6 decision tree","register":"essay","tags":["canonical","eu-ai-act","article-6","high-risk-ai","compliance","ongoing"],"updated_at":"2026-08-03T19:53:12.395Z","body_excerpt":"The EU AI Act does not classify a company, a model family or an industry as high-risk. It classifies an **AI system in its intended use**. The same general-purpose model can sit outside the high-risk regime when it drafts internal meeting notes and enter it when integrated into recruitment, credit, education, benefits, migration, policing or judicial decision-making.\n\nThis page turns Article 6 and Annex III into a decision record a provider, deployer, auditor or regulator can inspect. It reflects the AI Omnibus that entered into force on **27 July 2026**: Annex III high-risk obligations now apply from **2 December 2027**, while the product-safety systems in Article 6(1) apply from **2 August 2028**. Classification work remains necessary before those dates because intended purpose, contracts, technical documentation and system design decide which lane the operator is building toward.\n\n> **The decision in four lines**\n>\n> 1. Is the AI a safety component of, or itself, a regulated Annex I product that needs third-party conformity assessment? Article 6(1) high-risk.\n> 2. Is its intended use listed in Annex III? Presumptively Article 6(2) high-risk.\n> 3. If Annex III applies, does the system qualify for the narrow Article 6(3) derogation because it does not significantly risk health, safety or fundamental rights and does not materially influence a decision? Document that conclusion.\n> 4. If it profiles natural persons, the Annex III system remains high-risk despite the derogation.\n\n[[embed:source:s1]]\n\n## Step 0: freeze the intended purpose before classifying\n\nClassification begins with a versioned statement of intended purpose, not a product name. Record:\n\n```text\nSYSTEM_ID_AND_VERSION: <stable identifier>\nPROVIDER: <legal person developing or marketing under its name>\nDEPLOYER: <legal person using the system under its authority>\nINPUTS: <data the system receives>\nOUTPUTS: <prediction, recommendation, content or decision>\nUSERS: <roles operating or relying on it>\nAFFECTED_PERSONS: <whose rights, access, safety or opportunities can change>\nDECISION_POINT: <where output enters an operational decision>\nHUMAN_REVIEW: <authority, information, time and ability to reverse>\nPRODUCT_INTEGRATION: <standalone or safety component of named product>\nJURISDICTION_AND_MARKET: <where placed, put into service or output used>\n```\n\n“Assistant,” “copilot” and “decision support” are marketing descriptions. They do not answer whether the system materially influences an outcome. The record must say what the output changes.\n\n## Lane A: regulated products under Article 6(1)\n\nAn AI system is high-risk under Article 6(1) only when **both** conditions hold:\n\n1. the system is intended as a safety component of a product, or is itself a product, covered by Union harmonisation legislation listed in Annex I; and\n2. that product or system must undergo a third-party conformity assessment before market placement or service.\n\nThe lane covers product regimes such as medical devices, machinery, toys, lifts, personal protective equipment, radio equipment, motor vehicles, rail and civil aviation when the two-part test is met. Merely being embedded in hardware does not satisfy it. Merely touching safety does not identify the Annex I legislation or the third-party assessment.\n\n| Evidence needed | The question it answers |\n|---|---|\n| Exact Annex I legal instrument | Is the product family actually listed? |\n| Manufacturer’s intended-purpose statement | Is the AI the product or a safety component? |\n| Applicable conformity route | Is third-party assessment required? |\n| Architecture and failure analysis | What safety function does AI perform? |\n| Change-control record | Did a later modification create or alter the safety role? |\n\n[[embed:source:s2]]\n\n## Lane B: the eight Annex III areas\n\nArticle 6(2) treats AI systems in the listed Annex III uses as high-risk, subject to the paragraph 3 derogation. Match the **specific use**, not merely the sector.\n\n| Annex III area | In-scop","ranking":"safety-first (interaction_risk/limitations), then quote-gated effective_weight","claims":[{"id":"c10","text":"This decision tree is an operational guide, not legal advice or a regulator's classification; a defensible result requires the actual intended purpose, product context, decision influence, affected persons and modification history.","tier":"limitation","section":"The classification memorandum","slot":"limitations","interaction_risk":false,"status":"active","source_ids":["s1","s2"],"retracted_at":null,"retraction_reason":null,"challenged_by":[],"effective_weight":0.1,"quote_gated":false},{"id":"c1","text":"Article 6 creates two high-risk routes: regulated Annex I products requiring third-party conformity assessment and intended uses listed in Annex III.","tier":"primary-law","section":"The decision in four 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