Annex IV §9

Annex IV §9 Operational design domain / context of use

Who it binds: provider
Evidence that discharges it: a technical doc record
Usually owned by: Product
Severity: Major — a gap here is a finding an auditor will raise and expect a remediation plan for.

Does it apply to you?

Applicability under the Act is risk tier × operator role, not tier alone. This grid is computed by running the same function the assessment uses, so it cannot drift from what the product would tell you.

high riskprovider

Read against Regulation (EU) 2024/1689 as amended, consolidated text 02024R1689-20260727 (consolidation 001.001, incorporating Regulation (EU) 2026/1744). What we work from

Check which duties apply to you All obligations →