AI Act Conformity Assessment Support

Strengthen AI governance and align with the EU AI Act and ISO standards

AI Act Conformity Assessment Preparation for High-Risk AI Systems

  • Prepare high-risk AI systems for conformity assessment under the EU AI Act

  • Structure documentation, governance, and controls for provider and notified body review

  • Reduce regulatory risk and accelerate readiness for market entry

What Is an AI Act Conformity Assessment?

A conformity assessment under the EU AI Act is a structured evaluation process to verify that high-risk AI systems meet regulatory requirements before being placed on the market or put into service. It assesses whether appropriate controls are implemented across areas such as risk management, data governance, transparency, human oversight, accuracy, robustness, and cybersecurity.Depending on the system and use case, the assessment may be conducted internally or require involvement from a notified body. The outcome is a formal declaration that the AI system complies with the EU AI Act, supported by technical documentation, testing evidence, and governance controls.

Our Approach

1

Assess

Define scope, classify AI systems, and determine whether conformity assessment may be required.

2

Analyse

Review documentation, governance controls, and technical evidence against EU AI Act expectations.

3

Plan

Create a readiness roadmap to close gaps before formal conformity assessment.

4

Support

Support remediation, documentation, and preparation for provider-led or notified body review.

The Result: Clear Path to Market Access and Audit Readiness

Prepare for EU AI Act Conformity Assessment Process

Prepare your high-risk AI systems to successfully undergo conformity assessment, including notified body review where required.

Defensible and Audit-Ready Documentation

Support with conformity assessments, documentation, and reviews to ensure AI systems are transparent, defensible, and aligned with regulatory standard

Competitive Advantage in Procurement

Two people analyzing data on a large screen with charts, graphs, and a magnifying glass symbol, in a business or tech setting.

Build complete technical documentation and evidence to support regulatory scrutiny and third-party assessment.

Frequently Asked Questions

  • EU AI Act and must be completed before such systems are placed on the market or put into service.

    A system is classified as high-risk where:
    • It is used as a safety component of a product covered by Union harmonisation legislation (Annex I), or
    • It falls within specific use cases listed in Annex III

    Annex III covers high-impact areas where AI can significantly affect individuals or society, including:
    • Employment and worker management
    • Access to essential services such as credit scoring
    • Critical infrastructure
    • Law enforcement
    • Biometric identification

    The classification is based on the use case and potential impact, not the technology itself, making proper scoping and classification a critical first step.

  • A conformity assessment must be completed before a high-risk AI system is placed on the market or put into service.

    A new conformity assessment is required where the system undergoes a substantial modification, meaning changes that affect its compliance or intended purpose.

    Changes that were pre-defined and documented in advance within the technical documentation do not trigger a new assessment.

    Technical documentation must be prepared in advance and kept up to date throughout the lifecycle of the system.

    Primary reference: Art. 43
    Secondary references: Art. 11, Art. 16, Annex IV

  • Conformity assessment requires technical documentation demonstrating that the system complies with the requirements of the EU AI Act.

    This includes:
    • Documentation aligned with Annex IV
    • A quality management system covering governance and compliance processes
    • Supporting documentation where a notified body is involved

    Providers must also retain key documentation, including the EU declaration of conformity, for a defined period after the system is placed on the market.

    Primary reference: Art. 11
    Secondary references: Art. 17, Art. 47, Annex IV, Annex V

  • Most organisations do not struggle with understanding the requirements, but with operationalising them across teams and systems.

    Common challenges include:
    • Aligning legal, risk, and technical stakeholders
    • Embedding controls into development and operational workflows
    • Managing third-party and supplier dependencies
    • Maintaining consistent, audit-ready documentation

    Conformity assessment often exposes these gaps, particularly where governance, implementation, and documentation are not fully aligned.

    Early preparation and structured governance are therefore critical to avoid delays and rework later in the process.

  • Yes; in practice, conformity assessment preparation can be conducted remotely.

    The work involved is primarily documentation, governance alignment, and system review, which can be managed across distributed teams and environments.

    This includes:
    • Preparing and maintaining technical documentation
    • Establishing governance and control frameworks
    • Reviewing system design, data flows, and risk management processes

    Where external assessors or notified bodies are involved, access to relevant documentation, systems, and data may be required, which can also be provided through secure remote access where appropriate.