{
  "topic": "AI Act high-risk system obligations: legal basis and application dates",
  "last_verified_against": "Regulation (EU) 2026/1744, in force 27 July 2026; cross-checked against EAEC_WIJZIGINGSREGISTER_2026_1744, 25 August 2026",
  "application_dates": [
    {"date": "2027-12-02", "applies_to": "High-risk systems under Article 6(2) / Annex III", "legal_basis": "Article 113(3)(c)(i)"},
    {"date": "2028-08-02", "applies_to": "High-risk systems under Article 6(1) / Annex I (product route)", "legal_basis": "Article 113(3)(c)(ii)"}
  ],
  "legal_basis": [
    {"article": "Article 9", "requirement": "Risk management system", "nature": "continuous, iterative, throughout the system lifecycle, not a one-time assessment", "amended_2026_1744": false},
    {"article": "Article 11 / Annex IV", "requirement": "Technical documentation", "nature": "drawn up before market entry, kept up to date, structured per Annex IV", "amended_2026_1744": "SME/SMC simplified documentation route via Commission form added, Article 11(1)"},
    {"article": "Article 17", "requirement": "Quality management system", "nature": "documented written policies and procedures, not a single output", "amended_2026_1744": "proportionality to organisation size added, Article 17(2)"},
    {"article": "Article 63", "requirement": "Simplified QMS compliance", "nature": "extended from micro-enterprises to all SMEs including start-ups", "amended_2026_1744": true},
    {"article": "Article 43 / Annex VI", "requirement": "Conformity assessment (internal control route)", "nature": "provider verifies QMS (Art. 17), technical documentation (Annex IV) and post-market monitoring consistency (Art. 72), and declares compliance on its own responsibility", "amended_2026_1744": false}
  ],
  "key_fact": "For most Annex III high-risk categories, self-assessment (internal control) is the legally permitted route once the obligations apply; no third-party certification is required. Legal responsibility for the self-declaration rests solely with the provider.",
  "sme_accommodations_since_2026_1744": [
    "simplified technical documentation via Commission form (Article 11(1))",
    "quality management proportionate to organisation size (Article 17(2))",
    "simplified QMS compliance extended from micro-enterprises to all SMEs and start-ups (Article 63)"
  ],
  "scope_qualifications_since_2026_1744": [
    "Articles 9-15 and 17-25 may be limited to the extent that Annex I product legislation provides equivalent protection (Article 2(13))",
    "an AI system covered by the Cyber Resilience Act is presumed to comply with Article 15 (Article 42(3))"
  ],
  "what_a_one_time_form_does_not_produce": [
    "a continuous risk management process (Article 9)",
    "documentation that stays current over time (Article 11)",
    "a documented quality management system, even in simplified form (Article 17, Article 63)",
    "an ongoing consistency check with post-market monitoring (Article 43 / Annex VI)",
    "a record of whether it still reflects the law after the next amendment"
  ],
  "provider": {
    "name": "ROOTSbyNaeo",
    "legalName": "Stichting Everglades Consultants",
    "chamberOfCommerceNumber": "34186524",
    "statutorySeat": "Amsterdam",
    "country": "Netherlands",
    "products": ["ROOTS Scan", "ROOTS Dossier", "ROOTS Register"],
    "does_not_do": ["issue regulatory certification", "act as a notified body", "replace a legally required conformity assessment", "remove the provider's own Article 43 responsibility", "make a transitional-law determination for systems already on the market before the application date"]
  },
  "note": "This summary describes legal requirements and their application dates under the AI Act generally. It is not a compliance assessment of any specific system, and does not resolve transitional-law questions under Article 111 for systems already on the market."
}