Lampiran III Sistem AI Berisiko Tinggi: Panduan Klasifikasi Pasal 6
Pasal 6 dari Undang-Undang AI UE mendefinisikan dua jalur menuju klasifikasi berisiko tinggi. Panduan ini memandu Anda melalui kedua jalur tersebut, kategori kasus penggunaan dalam Lampiran III, pengecualian Pasal 6(3), dan bagan penilaian mandiri.
Lampiran III Sistem AI Berisiko Tinggi: Panduan Klasifikasi Pasal 6
Pasal 6 dari Undang-Undang AI UE mendefinisikan dua jalur menuju klasifikasi berisiko tinggi. Panduan ini memandu Anda melalui kedua jalur tersebut, kategori kasus penggunaan dalam Lampiran III, pengecualian Pasal 6(3), dan bagan penilaian mandiri.
Terakhir diperbarui: 4 Juli 2026
Apa yang Membuat Sistem AI Berisiko Tinggi?
Pasal 6 menciptakan dua jalur independen. Memenuhi salah satu dari keduanya akan membuat Anda menjadi berisiko tinggi — dan memicu dokumentasi penuh dalam Lampiran IV, kontrol Pasal 9–15, dan kewajiban penilaian kesesuaian.
Kedua jalur tersebut: Pasal 6(1) mencakup AI yang digunakan sebagai komponen keselamatan dalam produk yang diatur. Pasal 6(2) + Lampiran III mencakup AI mandiri dalam delapan kategori kasus penggunaan tertentu.
Jalur 1: Komponen Keselamatan (Pasal 6(1))
Jika AI Anda adalah komponen keselamatan dari produk yang tercakup dalam undang-undang sektor UE (perangkat medis, kendaraan, mesin, lift, mainan, dll.), atau merupakan produk itu sendiri, maka secara otomatis akan menjadi berisiko tinggi.
Penilaian kesesuaian harus dilakukan oleh badan yang ditunjuk.
Jalur 2: Kasus Penggunaan Lampiran III (Pasal 6(2))
Delapan kategori kasus penggunaan memicu klasifikasi berisiko tinggi terlepas dari teknologi yang mendasarinya:
- Biometrik: Sistem identifikasi biometrik jarak jauh dan pengenalan emosi
- Infrastruktur Kritis: AI dalam energi, air, gas, pemanas, dan infrastruktur digital
- Pendidikan: AI untuk penilaian siswa, penilaian ujian, dan analisis pembelajaran
- Ketenagakerjaan: Penyaringan CV, analisis wawancara, alokasi tugas, evaluasi kinerja, keputusan pemutusan hubungan kerja
- Layanan Esensial: Penilaian kredit, persetujuan pinjaman, penetapan harga asuransi, pengiriman layanan darurat
- Penegakan Hukum: Penilaian risiko, poligraf, evaluasi bukti, pembuatan profil
- Migrasi & Suaka: Aplikasi visa, proses suaka, pengendalian perbatasan
- Keadilan: Bantuan dalam penentuan hukuman, prediksi hasil kasus, penelitian hukum
Pengecualian Pasal 6(3)
Sistem AI dalam Lampiran III dapat dikecualikan jika tidak menimbulkan risiko signifikan terhadap kesehatan, keselamatan, atau hak-hak dasar.
Kasus yang diakui meliputi tugas prosedural yang sempit, meningkatkan hasil aktivitas manusia yang telah diselesaikan sebelumnya, mendeteksi pola pengambilan keputusan tanpa menggantikan penilaian manusia, atau tugas persiapan untuk pengambilan keputusan manusia berikutnya. Pembuatan profil selalu berisiko tinggi. Pengecualian tidak pernah berlaku jika sistem melakukan pembuatan profil terhadap orang alami.
Jika Anda mengklaim pengecualian, dokumentasikan alasannya secara menyeluruh. Regulator dapat menantangnya.
Persyaratan Dokumentasi Jika Berisiko Tinggi
Sistem AI berisiko tinggi harus memelihara dokumentasi kepatuhan yang komprehensif:
- Dokumentasi teknis Lampiran IV
- Sistem manajemen risiko Pasal 9
- Catatan tata kelola data Pasal 10
- Pencatatan dalam produksi Pasal 12
- Desain pengawasan manusia Pasal 14
- Penilaian kesesuaian + penandaan CE
- Pendaftaran database AI Uni Eropa
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.