Declare accuracy metrics in instructions for use
Choose appropriate accuracy metrics for the high-risk system and declare the levels and the metrics in the accompanying instructions for use; substantiate them in the technical documentation.
- Applies to
- Provider
- Applies from
- 2027-12-02 — Stand-alone high-risk (Annex III) obligations apply
- Derives from
- Article 15 · Article 11
- Primary source
- Art. 15 AIA
Evidence an auditor expects
- Accuracy Declaration Record — Dated record stating the chosen accuracy metric(s), target levels, the test set/conditions, and where they are declared in the instructions for use. Substantiated in the technical file.
- Instructions for use — Accompanying instructions where declared accuracy levels/metrics and other required information appear.
- Annex IV technical file — The full technical documentation package; primary evidence at conformity assessment; must be a living, versioned document.
Audit red flags
Fails an audit
- Accuracy levels/metrics not declared in the instructions for use.
- Documentation created after the fact rather than contemporaneously with the decision — national competent authorities apply the contemporaneous standard.
Common mistakes
- Declaring one headline accuracy number with no metric definition, test conditions or threshold rationale.
Fix: Declare the specific metric(s), the conditions/test set, and why the level is appropriate for the intended purpose.
FAQ
What evidence do I need for Article 15?
Accuracy Declaration Record, Instructions for use, Annex IV technical file. Each should be contemporaneous, versioned, and traceable to the system version.
When does “Declare accuracy metrics in instructions for use” apply?
From 2027-12-02 — Stand-alone high-risk (Annex III) obligations apply. It applies to: Provider.
What fails an audit here?
Accuracy levels/metrics not declared in the instructions for use.; Documentation created after the fact rather than contemporaneously with the decision — national competent authorities apply the contemporaneous standard.
Legal source
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