EU Declaration of Conformity Management

Create, approve, update, retain and produce the EU declaration of conformity for each applicable high-risk AI system.

For providers required to draw up an EU declaration of conformity, assign an owner and use a controlled declaration record. Check the applicable Annex V information against the system, conformity evidence and authorized signatory. Keep the declaration identifiable, up to date and in the required form and language. Retain it for the applicable period and make it available to competent authorities when required. A signed declaration should be supported by the conformity work; it is not a substitute for that work.

Before relevant market placement or putting into service; on changes affecting the declaration; retention and responses under the applicable requirement.

Approved declaration with system identification and signature Annex V completeness review and supporting conformity evidence Version history and change approvals Retention arrangements and authority-response records

Compare a declaration with the released system and assessment records. Check that required information and the signatory are supported, changes were reflected and an authorized user can retrieve the retained declaration.