AI Conformity Assessment Template
Step-by-step conformity assessment template for high-risk AI providers, covering both self-assessment (Annex VI) and notified body routes (Annex VII).
Quick Answer
High-risk AI conformity assessment requires testing against performance standards, validating technical documentation, completing a quality management audit, and drawing up an EU Declaration of Conformity before CE marking.
Compliance Checklist (8 items)
Penalty if not compliant
Up to €30 million or 6% of global annual turnover; market withdrawal orders from national supervisory authorities.
Frequently Asked Questions
Do all high-risk AI systems need a notified body for conformity assessment?
No. Most Annex III high-risk AI systems can use the self-assessment route. A notified body is required only when the AI system is a safety component of a product subject to third-party conformity assessment under existing EU harmonised legislation.
How long must conformity assessment records be kept?
Technical documentation, EU Declaration of Conformity, and all conformity assessment records must be retained for 10 years after the AI system is placed on the market or put into service.
Does conformity assessment need to be repeated after software updates?
Yes — substantial modifications that affect compliance (e.g., changes to intended purpose, training approach, or key performance characteristics) require a new conformity assessment before the updated system is deployed.
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