Conformity Assessment
CE marking & EU Declaration of Conformity – Art. 43, Annex VI & VII
System Identification
AI System name
Provider / Manufacturer
System version
Assessment date
Risk Classification
Risk level
-- Select --
High-risk (Annex III)
Limited risk (Art. 50)
Minimal risk
Annex III category (if high-risk)
Conformity Assessment Type
Assessment procedure
-- Select --
Internal control (Annex VI)
Third-party notified body (Annex VII)
Notified body (if applicable)
Technical Documentation (Annex IV)
Technical documentation complete?
-- Select --
Yes - All Annex IV requirements met
Partially complete
Not yet complete
Documentation includes:
Quality Management System
QMS implemented?
-- Select --
Yes - Documented QMS in place
In progress
Not yet implemented
QMS documentation reference
Testing & Validation
Testing completed?
-- Select --
Yes - All testing completed
Partially complete
Not yet started
Validation results summary
EU Declaration of Conformity
Declaration of Conformity prepared?
-- Select --
Yes - Ready to sign
Draft prepared
Not yet prepared
Harmonised standards applied
CE marking date (if applied)
Responsible person for declaration
Contact email
Additional notes
I confirm this conformity assessment information is accurate and complete.
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