Conformity Assessment is the formal, evidence-driven procedure mandated by the EU AI Act through which a provider demonstrates that a high-risk AI system complies with all applicable legal requirements before it can be placed on the market or put into service.

This process serves as the critical gatekeeper for high-risk AI, translating broad legal principles into verifiable technical and organizational proof. It is not a one-time audit but a rigorous lifecycle approach embedded in the provider’s development process. Depending on the specific system’s risk profile and intended use, the assessment may follow a lighter-touch internal control route or require the stringent, independent validation of a third-party Notified Body. The outcome is the foundation for affixing the CE marking, which acts as a passport for the AI system within the European single market.

A Conformity Assessment under the EU AI Act is built upon several core pillars of evidence:

Technical Documentation: Compiling comprehensive records that detail the system's design, development, performance, risk management, and conformity with requirements like transparency, accuracy, and robustness.

Quality Management System (QMS): Implementing and documenting a systematic process for design, development, testing, validation, and post-market monitoring to ensure consistent quality and compliance.

Risk Management: Demonstrating an ongoing process to identify, evaluate, and mitigate risks to health, safety, and fundamental rights throughout the AI system's lifecycle.

Performance Evaluation: Providing objective evidence, based on pre-defined metrics and testing procedures, that the system meets its accuracy, robustness, and cybersecurity specifications for its intended purpose.

Regulatory Context: The EU AI Act (Article 43, Title III) establishes the legal framework for conformity assessment. Annexes VI and VII detail the specific assessment procedures, with the more rigorous Annex VII (involving a Notified Body) required for certain high-risk systems listed in Annex I, such as those used in biometric identification or critical infrastructure management.

Strategic Importance: Successfully navigating conformity assessment is not merely a legal hurdle; it is a core competitive differentiator. A robust assessment process de-riskes product launches, builds trust with customers and regulators, and provides a defensible audit trail. Failure to complete a proper assessment results in the inability to legally market the system in the EU and exposes the provider to significant penalties and recall obligations.

‍