Annex I (AI Act)
Lists the product-safety sectoral legislation under which AI components embedded in covered products (medical devices, aviation, motor vehicles, toys, machinery) are classified as high-risk under Article 6(1). Section A of Annex I covers most EU harmonisation legislation where an AI safety component triggers high-risk status. Section B covers union harmonisation legislation where AI safety components trigger high-risk status and the Omnibus provides a different transition (amendments integrate into sectoral law upon Omnibus entry into force, per COM(2025) 836 Explanatory Memorandum, para 31, 19.11.2025).
Defined in 2 GAGE programs, which carry 4 distinct definitions of it. The wording above is taught in EU AI Act Implementation Expert.
How each discipline defines it
The same term does different work depending on who is using it. These are the definitions as each program teaches them, unedited.
Lists the product-safety sectoral legislation under which AI components embedded in covered products (medical devices, aviation, motor vehicles, toys, machinery) are classified as high-risk under Article 6(1). Section A of Annex I covers most EU harmonisation legislation where an AI safety component triggers high-risk status. Section B covers union harmonisation legislation where AI safety components trigger high-risk status and the Omnibus provides a different transition (amendments integrate into sectoral law upon Omnibus entry into force, per COM(2025) 836 Explanatory Memorandum, para 31, 19.11.2025).
The AI Act's category covering AI systems embedded in products already regulated by existing EU sectoral safety law (such as machinery, medical devices, and in-vitro diagnostic devices), whose conformity-assessment architecture was the specific dispute that stalled the Digital Omnibus trilogue on April 28, 2026, and whose obligations were ultimately deferred to August 2, 2028.
The list of Union harmonisation legislation whose product families can trigger Article 6(1) high-risk classification; divided into Section A (12 New Legislative Framework instruments, including MDR and IVDR) and Section B (8 other instruments, including motor vehicles and civil aviation).
The list of Union harmonisation legislation that, when applicable to a product, can trigger Article 6(1) high-risk classification. Divided into Section A (New Legislative Framework-based legislation, including MDR and IVDR) and Section B (other harmonisation legislation including aviation, rail, and automotive).
Where it is taught
The exact lessons this term appears in. The first module of every program is free with a free account.
- The Trilogue: Where an AI File Is Really Decided · The Brussels File: Influence Inside the EU Institutions, The AI Lobbyist: Certified AI Policy Strategist
- The Digital Omnibus: Conditional and Long-Stop Delays · Act Foundations and Current Timeline, EU AI Act Implementation Expert
- Annex I Integration: AI in Regulated Products · AI System Inventory and Classification, EU AI Act Implementation Expert
- Sector Overlap: MDR, IVDR, Financial Services, NIS2 and CRA · Regulatory Interplay and Liability, EU AI Act Implementation Expert
Where it shows up at work
A definition is where Annex I (AI Act) starts. The lessons above teach it inside the competencies below, which are what job descriptions ask for and what the GAGE credential records. Every link here is drawn from the same careers map that builds a role's readiness check.
Compares the EU AI Act, NIST AI RMF, ISO/IEC 42001 and sector rules by intent and control objective, and says where they do not overlap.
2 lessons on this page teach it as a primary outcome.
Classifies a system by role and risk tier, knows which obligations bind on which date after the Digital Omnibus, and what evidence conformity needs.
One lesson on this page teach it as a primary outcome.
Reviews purpose, data, affected people, accuracy, bias, security, oversight, vendors and law for a use case, scores likelihood and impact, and documents residual risk.
One lesson on this page teach it as a primary outcome.
Roles that hire for it
Each role page shows the full competency set, what the seat decides, and a readiness check against your own evidence.
- Senior AI Compliance Analystneeds it at depth
- AI Compliance Managerneeds it at depth · 2 open postings this week
- AI Compliance Specialistneeds working knowledge · 1 open posting this week
- Compliance Analystneeds working knowledge · 2 open postings this week
- Security Compliance Managerneeds it at depth · 4 open postings this week
- AI Regulatory Counselneeds it at depth · 14 open postings this week
How job descriptions say it
Postings rarely use the textbook word. These are the phrases the careers map reads as asking for the competencies above.
Where the frameworks place it: EU AI Act; NIST AI RMF; ISO/IEC 42001; Regulation (EU) 2024/1689.
One interview question about it
Map one control to the EU AI Act, NIST AI RMF and ISO/IEC 42001 at once, and tell me where the mapping breaks.
Asked of candidates for framework crosswalking without false equivalence. Answering it in your own words is exactly how a GAGE topic is passed, and the credential records the pass where an employer can check it.
If you come from another field
Some backgrounds already carry this competency, and the readiness check gives credit for it.
- A law degree (JD, LLB or LLM), no AI work yet carries it as a claim to back up: The EU AI Act reads like the statutes you were trained on; the content is new, the method is not.
- Privacy and data protection carries it as work you can show: A DPIA is an impact assessment; the AI version adds accuracy, bias and oversight.
Terms it appears with
Not an alphabetical neighbourhood: these are the terms taught in the same lessons, ranked by how often they appear together.