EU-AIA-11-05
Documentation
11 — Technical documentation
Use Commission's Simplified Form When Opting for Simplified SME/SMC Documentation
Description
Full Analysis & Evidence Requirements
Sign in to view the full obligation text, AI-generated applicability analysis, evidence checklists, and compliance mapping.
Sign In to ViewRelated Obligations
EU-AIA-11-01
Documentation
Draw Up Technical Documentation Before Market Placement
EU-AIA-11-01-superseded-20261013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EU-AIA-11-02-superseded-20261013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EU-AIA-11-03-superseded-20261013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EU-AIA-11-04-superseded-20261013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EU-AIA-11-05-superseded-20261013
Documentation
Create single technical documentation for harmonized products
EU-AIA-11-06
Conformity
Notified Bodies Must Accept Simplified SME/SMC Documentation Form
Map this obligation to your AI systems
ReguLume automatically maps regulatory obligations to your system inventory, identifies compliance gaps, and generates remediation plans.
Get Started