06 · High-Risk AI Classification
- EC Digital Strategy + Draft high-risk guidelines (May 2026) + FLI summary + Pinsent Masons guide
- Annex III high-risk Chapter III, Sections 1–3 obligations: 2 December 2027 under PE-CONS 30/26, pending OJ publication. Annex I high-risk Chapter III, Sections 1–3 obligations: 2 August 2028 under PE-CONS 30/26, pending OJ publication.
Annex III high-risk Chapter III, Sections 1–3 obligations: 2 December 2027 under PE-CONS 30/26, pending OJ publication. Annex I high-risk Chapter III, Sections 1–3 obligations: 2 August 2028 under PE-CONS 30/26, pending OJ publication.
Two tracks into high-risk classification (Article 6)
Track 1 — Annex I (regulated products)
AI systems that are a safety component of a product covered by existing EU product safety laws in Annex I (e.g. machinery, toys, medical devices, aviation, motor vehicles, rail, lifts) and that product requires third-party conformity assessment under those Annex I laws.
→ Under PE-CONS 30/26, Article 6(1) / Annex I high-risk systems move to 2 August 2028.
Track 2 — Annex III (use cases)
AI systems listed in specific use-case areas in Annex III. Currently 8 areas:
| Area | Examples |
|---|---|
| Biometrics (non-banned) | Remote biometric ID, biometric categorisation, emotion recognition (not banned) |
| Critical infrastructure | AI managing road traffic, water/gas/electricity/heating, digital infrastructure |
| Education & vocational training | Admission decisions, exam scoring, student behaviour monitoring |
| Employment & HR | CV screening, interview analysis, promotion/termination, performance monitoring |
| Essential public & private services | Benefits eligibility, credit scoring, emergency call dispatch, insurance risk pricing |
| Law enforcement | Victim risk assessment, evidence reliability evaluation, offending risk (non-solo profiling) |
| Migration & border control | Visa/asylum examination, border crossing irregular migration risk |
| Justice & democratic processes | Court ruling assistance, election/voting influence tools |
→ Under PE-CONS 30/26, Article 6(2) / Annex III high-risk systems move to 2 December 2027.
Exceptions — Annex III systems that are not high-risk
An AI system listed in Annex III is not classified high-risk if it:
- Performs a narrow procedural task
- Improves the result of a previously completed human activity
- Detects decision-making patterns without replacing human judgment
- Performs a preparatory task to an assessment (i.e. not the assessment itself)
Exception does not apply if the system profiles individuals — automated processing of personal data to assess work performance, economic situation, health, preferences, reliability, behaviour, location, or movement. Profiling always makes the system high-risk.
Providers whose system falls under Annex III but believe it's not high-risk must document that assessment before market placement.
Obligations on high-risk AI providers
Once classified high-risk, providers must:
| Obligation | Article |
|---|---|
| Risk management system (documented, lifecycle-long) | Art. 9 |
| Data governance (relevant, representative, error-free datasets) | Art. 10 |
| Technical documentation (Annex IV format) | Art. 11 |
| Automatic event logging / record-keeping | Art. 12 |
| Instructions for use (for deployers) | Art. 13 |
| Human oversight design | Art. 14 |
| Accuracy, robustness, cybersecurity | Art. 15 |
| Quality management system | Art. 17 |
Obligations on high-risk AI deployers
- Implement human oversight as instructed by providers
- Monitor system performance in production
- Report serious incidents and malfunctions to providers and national authorities
- Conduct fundamental rights impact assessments (for certain deployers — public bodies, banks, insurers)
Conformity assessment
See 07 · Conformity Assessment for the full process.
- For Annex I (product safety) systems: third-party notified body assessment
- For most Annex III systems: self-assessment (internal conformity assessment) is sufficient
- Exception: biometric identification systems (public-space RBI, remote biometric ID) require third-party assessment
After assessment: affix CE marking and issue EU declaration of conformity.
Post-market: register in the EU database (for Annex III systems used by or against individuals). Public authorities deploying high-risk AI must register before deployment.
Draft classification guidelines (May 2026)
The Commission opened consultation in May 2026 on draft guidelines clarifying the classification rules — specifically the Article 6 exceptions. These guidelines were due by 2 Feb 2026 (Art. 6(5)) but published in draft form for consultation in May 2026. URL: https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems
Key articles and annexes
| Topic | Reference |
|---|---|
| Classification rules | Art. 6 |
| Annex I (regulated product laws) | Annex I |
| Annex III (use cases) | Annex III |
| Risk management | Art. 9 |
| Data governance | Art. 10 |
| Technical documentation | Art. 11 + Annex IV |
| Record-keeping | Art. 12 |
| Transparency to deployers | Art. 13 |
| Human oversight | Art. 14 |
| Accuracy/robustness/cybersecurity | Art. 15 |
| Quality management | Art. 17 |
| Conformity assessment | Arts. 43–49 |
| EU database | Art. 71 |
| Fundamental rights impact assessment | Art. 27 |