Lampiran III Sistem AI Berisiko Tinggi: Panduan Klasifikasi Artikel 6
Artikel 6 Akta AI EU menentukan dua laluan untuk klasifikasi berisiko tinggi. Panduan ini membimbing anda melalui kedua-duanya, kategori kes penggunaan Lampiran III, pengecualian Artikel 6(3) dan carta aliran penilaian kendiri.
Lampiran III Sistem AI Berisiko Tinggi: Panduan Klasifikasi Artikel 6
Artikel 6 Akta AI EU menentukan dua laluan untuk klasifikasi berisiko tinggi. Panduan ini membimbing anda melalui kedua-duanya, kategori kes penggunaan Lampiran III, pengecualian Artikel 6(3) dan carta aliran penilaian kendiri.
Terakhir dikemas kini: 4 Julai 2026
Apa yang Menjadikan Sistem AI Berisiko Tinggi?
Artikel 6 mewujudkan dua laluan yang berasingan. Tergolong dalam mana-mana satu menjadikan anda berisiko tinggi — dan mencetuskan dokumentasi penuh Lampiran IV, kawalan Artikel 9–15 dan kewajipan penilaian pematuhan.
Dua laluan: Artikel 6(1) merangkumi AI yang digunakan sebagai komponen keselamatan dalam produk yang dikawal. Artikel 6(2) + Lampiran III merangkumi AI yang berdiri sendiri dalam lapan kategori kes penggunaan tertentu.
Laluan 1: Komponen Keselamatan (Artikel 6(1))
Jika AI anda ialah komponen keselamatan bagi produk yang dilindungi oleh undang-undang sektor EU (peranti perubatan, kenderaan, jentera, lif, mainan, dsb.), atau ia sendiri merupakan produk sedemikian, ia secara automatik berisiko tinggi.
Penilaian pematuhan mesti dijalankan oleh badan yang diiktiraf.
Laluan 2: Kes Penggunaan Lampiran III (Artikel 6(2))
Lapan kategori kes penggunaan mencetuskan klasifikasi berisiko tinggi tanpa mengira teknologi yang mendasari:
- Biometrik: Sistem pengenalan biometrik dan pengecaman emosi jarak jauh
- Infrastruktur Kritikal: AI dalam tenaga, air, gas, pemanasan dan infrastruktur digital
- Pendidikan: AI untuk penilaian pelajar, pemarkahan peperiksaan dan analisis pembelajaran
- Pekerjaan: Penyaringan CV, analisis temu duga, peruntukan tugas, penilaian prestasi, keputusan pemberhentian
- Perkhidmatan Asas: Penilaian kredit, kelulusan pinjaman, penetapan harga insurans, penghantaran perkhidmatan kecemasan
- Penguatkuasaan Undang-undang: Penilaian risiko, ujian pendeteksi pembohong, penilaian bukti, profil
- Migrasi & Suaka: Permohonan visa, pemprosesan suaka, kawalan sempadan
- Keadilan: Bantuan hukuman, ramalan hasil kes, penyelidikan undang-undang
Pengecualian Perkara 6(3)
Sistem AI dalam Lampiran III boleh dikecualikan jika ia tidak menimbulkan risiko yang besar kepada kesihatan, keselamatan atau hak asasi.
Kes yang diiktiraf termasuk tugas prosedur yang terhad, meningkatkan hasil aktiviti manusia yang telah diselesaikan sebelum ini, mengesan corak keputusan tanpa menggantikan penilaian manusia, atau tugas persediaan untuk keputusan manusia seterusnya. Pembentukan profil sentiasa berisiko tinggi. Pengecualian tidak pernah terpakai jika sistem melakukan pembentukan profil terhadap orang semula jadi.
Jika anda menuntut pengecualian, dokumentasikan alasan dengan teliti. Pihak pengawal selia mungkin mencabar tuntutan tersebut.
Keperluan Dokumentasi Jika Berisiko Tinggi
Sistem AI berisiko tinggi mesti mengekalkan dokumentasi pematuhan yang komprehensif:
- Dokumentasi teknikal Lampiran IV
- Sistem pengurusan risiko Perkara 9
- Rekod tadbir urus data Perkara 10
- Pencatatan dalam pengeluaran Perkara 12
- Reka bentuk pengawasan manusia Perkara 14
- Penilaian kesesuaian + tanda CE
- Pendaftaran dalam pangkalan data AI EU
How AIAgentree helps
If your system is high-risk, AIAgentree produces the ongoing evidence that classification triggers:
- Article 12 automatic decision logging — tamper-evident, captured via SDK, MCP, A2A, or the OpenTelemetry bridge with no rewrite
- Article 14 human-oversight and approval workflows that record who overrode what, when, and why
- Audit-fit retention (at least six months) plus Annex IV-aligned exports for your technical file, with EU data residency (Germany)
Frequently Asked Questions
How do I know if my AI system is high-risk under Annex III?
Work through the two Article 6 pathways: (1) your system is a safety component of a product covered by the EU legislation in Annex I, or (2) it falls into one of the Annex III use cases (biometrics, critical infrastructure, education, employment, essential services, law enforcement, migration, justice). If either applies and no Article 6(3) exemption holds, it is high-risk.
What is the Article 6(3) exemption?
An Annex III system can avoid high-risk status if it does not pose a significant risk to health, safety, or fundamental rights — for example narrow procedural tasks or preparatory work for a human decision. Profiling of natural persons is always high-risk, and you must document your exemption reasoning because regulators can challenge it.
When do high-risk obligations start applying?
For stand-alone Annex III high-risk systems, full obligations apply from August 2, 2026. AI that is a safety component of products regulated under existing EU sectoral law reaches full applicability on August 2, 2027.
What happens once my system is classified high-risk?
You must implement Article 9 risk management, Article 10 data governance, Article 11/Annex IV technical documentation, Article 12 logging, Article 14 human oversight, complete a conformity assessment, affix CE marking, and register in the EU database. AIAgentree covers the logging, oversight, and audit-evidence portion of that stack.
Continue exploring the EU AI Act guide
EU AI Act Compliance Guide
The complete guide to EU AI Act compliance for AI agents — start here.
Article 12 — Record-Keeping & Logging
What every high-risk AI system must log, and how to capture it.
Article 14 — Human Oversight
Designing effective human-in-the-loop controls for AI decisions.
EU AI Act Compliance Checklist
A step-by-step checklist to reach and document compliance.
Compliance Cost Calculator
Estimate your EU AI Act compliance effort and cost.
Deadlines & Timeline
Key enforcement dates, including the August 2, 2026 deadline.
Fines & Penalties
Penalty tiers up to €35M or 7% of global annual turnover.
Transparency Obligations (Art. 13 & 50)
Disclosure duties for AI systems and their outputs.
Risk Management & Conformity Assessment
Build a risk management system and assess conformity.
GPAI Obligations
Rules for providers of general-purpose AI models.
EU AI Act for US Companies
Extraterritorial scope and what US providers must do.
Omnibus Update
The latest changes to the EU AI Act timeline and rules.
Penalty Calculator
Estimate your maximum fine under the Article 99 tiers.
Article 11 + Annex IV
What technical documentation the EU AI Act requires.
Article 26: Deployer Obligations
What deployers of high-risk AI must do, including log retention.
Article 17: Quality Management
The QMS providers of high-risk AI must document.
Article 10: Data Governance
Data quality, bias mitigation, and governance duties.
Article 4: AI Literacy
The staff AI-literacy duty in force since February 2025.
Deployer vs Provider
Who bears which obligation — and when a deployer becomes a provider.
FRIA (Article 27)
Who must run a Fundamental Rights Impact Assessment, and how.
Who Does It Apply To?
Scope, operators, and the extraterritorial reach of the EU AI Act.
Post-Market Monitoring
Articles 72–73: ongoing monitoring and incident reporting.
ISO 42001 vs EU AI Act
How the voluntary standard and the binding law fit together.
NIST AI RMF vs EU AI Act
A practical crosswalk between the framework and the law.
EU AI Act for Healthcare
High-risk medical AI, MDR/IVDR interplay, and clinician oversight.
EU AI Act for Financial Services
Credit scoring, insurance pricing, and existing financial regulation.
EU AI Act for HR & Employment
Hiring AI as high-risk, plus NYC LL144 and EEOC overlap.