EU-AIA-11-01 Documentation 11 — Technical documentation

Draw Up Technical Documentation Before Market Placement

Description

Providers of high-risk AI systems must draw up technical documentation before the system is placed on the market or put into service. This documentation must demonstrate compliance with the requirements set out in Section 2 (Articles 8-15) of the Regulation and contain, at minimum, the elements set out in Annex IV.

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Related Obligations

EU-AIA-11-01-superseded-20261013 Documentation

Draw up technical documentation before market placement/service

EU-AIA-11-02 Documentation

Keep Technical Documentation Up to Date

EU-AIA-11-02-superseded-20261013 Documentation

Keep technical documentation up to date

EU-AIA-11-03 Documentation

Ensure Documentation Demonstrates Compliance and Is Clear/Comprehensive for Authorities

EU-AIA-11-03-superseded-20261013 Documentation

Include minimum elements from Annex IV in technical documentation

EU-AIA-11-04 Documentation

Include Minimum Elements Per Annex IV

EU-AIA-11-04-superseded-20261013 Documentation

Use simplified technical documentation form (SMEs)

EU-AIA-11-05 Documentation

Use Commission's Simplified Form When Opting for Simplified SME/SMC Documentation

EU-AIA-11-05-superseded-20261013 Documentation

Create single technical documentation for harmonized products

EU-AIA-11-06 Conformity

Notified Bodies Must Accept Simplified SME/SMC Documentation Form

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