Rule reference
This page is documentation, not a worklist. It states which rules each governance gate reads, so a finding raised inside an AI System can be traced back to the rule that produced it. The findings themselves live under Gaps and readiness within each AI System.
Governance gates
Shared across every industry profile.
| Gate | Purpose | Decided by | Rules read |
|---|---|---|---|
| Development authorisation | Authorises development against a stated intended purpose. | Independent Reviewer | STRUCT-01, STRUCT-02 |
| Model approval | Approves an immutable AI Model Version for use. | Independent Reviewer | TRACE-01, TRACE-02, DATA-01, DATA-02 |
| System approval for operation | Approves the complete AI System for operation in a market. | Independent Reviewer | STRUCT-01, STRUCT-02, APPR-01, RISK-01, RISK-03, REV-02, CONF-01 |
| Change authorisation | Authorises a change inside the Controlled Evolution boundaries. | Quality and Regulatory | CE-01, CE-02, CE-03, REV-01, RISK-01, MON-01 |
| Resumption | Resumes operation after restriction or suspension. | Independent Reviewer | MON-01, RISK-01, REV-01 |
Profile rules
The industry profile adds rules to the shared set and feeds them into the gates.
Medical device and SaMD
Software placed on the market as a medical device, or as part of one. Carries device classification, the UDI family and, where change is planned, a PCCP.
| Gate | Rules added by this profile |
|---|---|
| system approval | UDI-01, UDI-02, CLASS-01, REPRO-01 |
| change authorisation | UDI-04, REPO-01, SIG-01 |
| model approval | REPRO-01 |
| resumption | SIG-01 |
| development authorisation | CLASS-01 |
Financial services
Models used in credit, pricing, trading, fraud or capital decisions. Carries independent validation, challenger comparison and fairness testing.
| Gate | Rules added by this profile |
|---|---|
| system approval | FIN-01, CLASS-01, REPRO-01 |
| change authorisation | REPO-01, SIG-01 |
| model approval | REPRO-01, FIN-02 |
| resumption | SIG-01 |
| development authorisation | CLASS-01 |
Employment and HR technology
Systems used in recruitment, selection, promotion or termination. High-risk under Annex III, and subject to bias audit and candidate transparency duties.
| Gate | Rules added by this profile |
|---|---|
| system approval | EMP-01, CLASS-01, REPRO-01 |
| change authorisation | REPO-01, SIG-01 |
| model approval | REPRO-01 |
| resumption | SIG-01, EMP-01 |
| development authorisation | CLASS-01 |
Industrial and critical infrastructure
Systems that control or supervise physical process, plant or infrastructure. Carries functional safety, declared operational limits and a human oversight plan.
| Gate | Rules added by this profile |
|---|---|
| system approval | IND-01, IND-02, CLASS-01, REPRO-01 |
| change authorisation | REPO-01, SIG-01 |
| model approval | REPRO-01 |
| resumption | SIG-01 |
| development authorisation | CLASS-01 |