Article 11: Technical documentation

Requires the Annex IV technical documentation to be drawn up before market placement and kept up to date.

Applies from 2027-12-02Obligations 2

Obligations under this article

Declare accuracy metrics in instructions for use — Provider
Draw up & maintain the Annex IV technical file — Provider

Legal source

Art. 11 AIA · Annex IV AIA

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Not legal advice. This is a practitioner reference generated from a cited knowledge base built on the primary legal text and official Commission guidance. Verify against the cited primary sources before relying on it for a compliance decision. See editorial standards & methodology.