High‑Risk AI System

AI systems classified under the EU AI Act taxonomy (notably Articles 6–8 and the Annexes) as posing a significant risk to health, safety or fundamental rights, and therefore subject to mandatory conformity assessments, technical documentation, risk‑management and supervisory obligations at EU or national level.

A High‑Risk AI System is any AI whose deployment or outputs may substantially affect individuals' health, safety, fundamental rights or the outcomes of administrative procedures; such systems are eligible for stricter lifecycle governance, additional testing, validation and conformity assessment requirements. The Secretariat may classify categories as high‑risk and impose proportional compliance paths and oversight measures.

AI systems that have substantial potential to affect fundamental rights, safety, or public interests; the draft gives examples such as automated diagnostic tools, biometric identification systems, decision support for social benefits or immigration, and critical‑infrastructure control systems.

AI systems that are identified in Annex III as posing significant risks to health, safety or fundamental rights, including systems used in critical sectors; these systems are subject to enhanced obligations such as mandatory risk‑management, data governance, testing, human oversight, logging, conformity assessment and registration prior to market placement.

AI systems whose purpose or foreseeable impact affects fundamental rights or critical societal functions—such as systems used in health, criminal justice, employment, credit scoring or essential public services—and which are therefore subject to mandatory DPIAs, third‑party conformity assessment, pre‑deployment certification, registration and heightened monitoring requirements under the bill.

An AI system whose design, intended purpose or deployment may significantly affect fundamental rights, safety, health, economic or other critical interests and therefore requires heightened oversight; high‑risk systems trigger obligations such as mandatory impact assessments, documentation, registration and, where applicable, third‑party conformity assessment. High risk is determined by criteria set out in the bill and sectoral specifications.

An AI system classified as high‑risk pursuant to the lists established by Regulation (EU) 2024/1689 and any national extensions defined by the implementing decrees; such systems are subject to mandatory risk assessments, enhanced technical documentation, accredited conformity assessment procedures, and intensified market surveillance.

AI systems falling within the Annexes and criteria of the EU AI Act as adopted into national implementation, which under LN 226 are subject to mandatory risk management, technical documentation, conformity assessment, registration, post‑market monitoring and enhanced transparency and oversight obligations by providers and importers.

A category in the draft risk‑based framework for AI systems whose intended use or potential impacts pose significant risks to fundamental rights, safety, health, critical infrastructure, or other protected interests; such systems are subject to prior conformity assessment, registration, impact assessment, and stricter governance measures. The drafts specify examples and regulatory obligations tied to this classification.

AI systems classified as posing material risks to life, safety, health, or fundamental rights, typically used in critical sectors such as energy and water, medical care and medical devices, critical infrastructure, employment and credit decisions, transport, and public sector systems. High‑risk designation triggers mandatory duties like impact assessments, prior verification/confirmation, safety testing, stricter transparency, documentation, monitoring, and incident reporting.

Any AI system classified under the bill's risk‑level framework as presenting a high expected risk to fundamental labor rights, workplace health or non‑discrimination; such systems are subject to enhanced obligations (e.g., registration, conformity assessment, third‑party audits, and stricter documentation and impact assessment requirements). The bill also distinguishes other tiers (null/low, limited, unacceptable) within its risk classification scheme.

An AI system classified as high‑risk under the categories listed in Annex III (e.g., safety components, critical infrastructure, biometric identification, employment decisions, essential services), which must meet detailed requirements including risk management, dataset quality, technical documentation, human oversight, conformity assessment and registration before being placed on the market.

AI systems whose intended use and sectoral application are listed in Annex III (e.g., critical infrastructure, education, employment, law enforcement, migration, safety‑critical products) and that, because of their potential impact on health, safety or fundamental rights, are subject to mandatory conformity assessment, risk‑management, data governance, documentation, human oversight and post‑market monitoring obligations.

Systems falling into categories listed in the EU AI Act and transposed by national implementing measures; by virtue of their intended use they pose significant risks to health, safety, fundamental rights or other regulated interests and are therefore subject to enhanced conformity requirements, oversight and market surveillance.

An AI system designated as high‑risk based on sectoral lists aligned with the EU AI Regulation; such systems are subject to stringent obligations including data governance, technical documentation, risk management, human oversight, conformity assessment, CE‑type marking, and registration.

AI systems classified pursuant to the EU AI Regulation and adopted in the draft as those posing substantial risks to health, safety, or fundamental rights; such systems trigger provider and deployer obligations including conformity assessment, technical documentation, risk management, post‑market monitoring, and registration in national/EU registries.

AI systems that, by intended purpose and impact (including those listed in the Act's Annexes), present significant risks to health, safety or fundamental rights and are therefore subject to mandatory risk management, data governance, technical documentation, human oversight, conformity assessment and registration requirements.

Systems listed in Annex III or otherwise designated as high‑risk because they pose significant risks to health, safety or fundamental rights; they are subject to extensive pre‑market and post‑market obligations including risk management, data governance, technical documentation, human oversight, conformity assessment and mandatory registration.

An AI system category defined by the draft as posing significant societal, economic or safety impacts, subject to mandatory pre‑deployment impact and risk assessments, mitigation measures, documentation and possible registration or conformity assessment.