High-Risk AI System Providers – What You Need to Know

The EU AI Act introduces legally binding requirements for high-risk AI systems, including a mandatory conformity assessment before such systems can be deployed in the European Union. These assessments are not optional they are a legal gateway to market access and require rigorous preparation, technical documentation, and in some cases, third-party certification by a Notified Body.

This guide explains:

What conformity assessments are and why they are required
How to determine if your system falls under the high-risk category
Which assessment route applies to your system (self-assessment or external)
What technical and procedural obligations must be met
How Anekanta® supports organisations at every stage of this process — from early risk classification through to post-market monitoring

With the deadline of 2 August 2026 fast approaching, proactive preparation is essential. Whether you’re a provider, deployer, or legal advisor supporting compliance efforts, this page outlines the key actions you should be taking — and how Anekanta® can help you lead with confidence.

Why Are Conformity Assessments Required?

Conformity assessments are required under the EU AI Act Article 43 to ensure that high-risk AI systems meet strict legal, technical, and ethical standards before they are placed on the EU market or put into service. These assessments are not merely procedural they are a core mechanism for protecting the health, safety, and fundamental rights of individuals potentially affected by AI. Furthermore, conformity assessments are the means by which buyers can be confident that the AI system meets the legal requirements for use in the EU.

Without conformity assessments, there is a risk that unverified or poorly designed systems could cause harm, discrimination, or legal breaches. The assessment process therefore acts as a quality gate, ensuring that AI providers can demonstrate compliance with the essential requirements of the Act as laid out in Chapter III Section 2 (Articles 8–15).

The EU has adopted a risk-based regulatory approach, and high-risk systems are those that are likely to significantly affect people’s lives — such as in hiring decisions, access to education, law enforcement, biometric identification, and public services. For such systems, the law mandates proactive scrutiny before deployment (ex ante), to ensure that:

The system is trained and tested on high-quality, representative data;
Risks are identified, assessed, and appropriately mitigated;
There is clear human oversight and accountability;
The system’s operations are transparent, explainable, and traceable;
Users are properly informed of the system’s capabilities and limitations;
Ongoing monitoring mechanisms are in place for post-market risks.

These processes also promote legal certainty and trust in the market by aligning AI development with EU values and regulatory expectations. They provide a structured framework that helps organisations build responsible AI systems and prepare for external audits by notified bodies where applicable.

How to Identify a High-Risk AI System

Identifying whether an AI system is classified as “high-risk” under the EU AI Act requires a structured analysis based on the system’s intended purpose and context of use. High-risk systems are those that fall within one of the use cases listed in Annex III of the Act, including areas such as biometric identification, biometric categorization, critical infrastructure management, education, employment, access to public services, law enforcement, migration control, and the administration of justice.

The classification is based on the functions of the AI system and the deployment context determines risk. In addition to matching an Annex III use case, the system must also meet the definition of an “AI system” under Article 3(1) and be placed on the market or put into service in the EU. Organisations must conduct a thorough risk and use-case mapping exercise, taking into account the system’s autonomy, its impact on fundamental rights, and whether it supports or replaces human decision-making in sensitive domains.

Anekanta®’s Role in Facilitating EU AI Act Conformity Assessment Compliance

The conformity assessment process under the EU AI Act can be complex and resource-intensive, particularly for organisations developing or deploying high-risk AI systems. Anekanta® offers expert, end-to-end support to guide your organisation through every phase from system design to post-market obligations ensuring you remain aligned with the regulatory, ethical, and operational expectations of the Act.

Compliant AI System Development Support

We work confidentially under NDA to assess AI development plans and system architectures at an early stage, identifying potential design and implementation risks. This includes recommending technical or governance-related changes that reduce the likelihood of high-risk classification without sacrificing core functionality or innovation.

Our approach helps prevent the “tunnel vision” that can occur when AI systems are developed in siloed teams without governance oversight. Developers may not anticipate future or abstract misuse scenarios, particularly those that fall within Annex III (e.g., biometrics, employment, education, law enforcement). We bring critical foresight into these use cases to ensure risks are addressed before they become embedded in the product.

By advising at the inception stage, we help steer development decisions away from non-compliant pathways significantly reducing the likelihood of costly retrofitting or delayed deployment due to regulatory intervention.

Risk Classification and Scoping

Accurately identifying whether your AI system qualifies as high-risk is the essential first step in determining your compliance obligations.

We support detailed classification exercises, mapping your system’s purpose and capabilities against Annex III categories (e.g., 1: Biometric identification and categorisation 2–8: access to education, employment, etc.).
Our proprietary AI Risk Intelligence System™ for biometric and high-risk AI, featured by the UK Government and OECD Catalogue of Tools & Metrics for Trustworthy AI, underpins our analytical methodology and ensures an objective, evidence-based approach to scoping.
Where feasible, we offer strategic advice on how to adjust your system’s architecture or use case to avoid unnecessary classification as high-risk — reducing regulatory burden without compromising performance.

We also advise on whether the system is covered by an existing sectoral regime (e.g., medical devices, aviation), which may involve additional obligations.

Conformity Assessment Strategy

Once risk classification is complete, the next step is choosing the appropriate assessment route:

We guide you in determining whether Annex VI (internal control/self-assessment) or Annex VII (third-party conformity assessment by a Notified Body) applies to your system.
We analyse the applicability of harmonised standards, which, if fully complied with, allow for presumption of conformity through internal control assessments.
For organisations subject to Annex VII, we support the design and implementation of a Quality Management System (QMS) in line with Article 17 and associated annexes.

Technical Documentation

Anekanta® assists in building and maintaining the technical artifacts required under Annex IV, which serve as the core evidence for conformity:

System description and intended purpose
Architecture, training methodologies, data lineage
Human oversight mechanisms
Risk assessment and mitigation documentation
Testing results and validation metrics

Engagement with Notified Bodies

For AI systems requiring external conformity assessment under Annex VII, we help your organisation prepare for, and engage with, the appropriate Notified Bodies:

Audit preparation and readiness reviews
Response strategies to findings or objections
Process harmonization across technical and legal teams

Post-Market Monitoring and Incident Reporting

The EU AI Act mandates that high-risk systems undergo continuous monitoring and responsiveness once deployed:

We help you understand your obligations for a Post-Market Monitoring System in accordance with Article 72 capturing real-world data, performance drift, and unforeseen risks.
We assist in developing procedures for the reporting of serious incidents as required by Article 73, including escalation protocols and documentation for competent authorities.

Preparing for Compliance

With the EU AI Act’s high-risk provisions becoming applicable from 2 August 2026, the window for preparation is closing fast. Delayed engagement may result in missed compliance milestones, reputational damage, or legal liability. Early action on EU AI Act use case risk classification allows your organisation to future-proof its AI pipeline while positioning itself as a responsible market leader.

Get Expert Help Today

Whether you are designing a system from scratch or auditing an existing one, Anekanta® can help you:

Evaluate and mitigate risk
Classify your AI use case accurately
Navigate conformity assessments with confidence
Choose and implement GRC tools suitable for the EU AI Act environment

Contact Anekanta® to begin your compliance journey today.

Note: This article is intended for informational purposes and does not constitute legal advice.

Early action on EU AI Act use case risk classification allows your organisation to future-proof its AI pipeline while positioning itself as a responsible market leader.

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