Art.26
EU AI Act Guide › Chapter III — High-Risk AI Systems › Article 26

Article 26 — Obligations of Deployers of High-Risk AI Systems

SME Key SME Relevant ~3 min read · 653 words

Article 26 is the single most important article for the majority of businesses operating in the EU. Most companies are not building high-risk AI — they are buying and using it. This article defines what every deployer of a high-risk AI system must do: from implementing oversight measures to informing workers, monitoring performance, and notifying authorities of incidents.

! High compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

The compliance obligations of businesses that use high-risk AI

Article 26 is the deployer counterpart to Article 16’s provider obligations. It establishes a comprehensive set of duties for any organisation that deploys a high-risk AI system in a professional context — whether that means an HR team using an AI screening tool, a bank using a credit scoring model, or a public authority using a risk assessment system. If you use high-risk AI, this article governs what you must do.

WHAT IT SAYS

Twelve obligations across oversight, monitoring, disclosure and cooperation

  • Deployers must implement the human oversight measures specified by the provider in the instructions for use — and assign qualified, competent individuals to carry out that oversight
  • Deployers must use high-risk AI systems in accordance with the instructions for use provided under Article 13
  • Deployers must monitor the operation of the high-risk AI system and inform providers where they have reason to believe the system presents a risk
  • Where a serious incident is identified, deployers must immediately inform the provider, then the importer or distributor, and then the relevant market surveillance authority
  • Deployers must keep the automatically generated logs for at least six months
  • Deployers must carry out a data protection impact assessment where required by GDPR, using the information provided in the instructions for use
  • Where deployers control input data, they must ensure it is relevant and sufficiently representative for the intended purpose
  • Deployers who are employers must inform workers and their representatives before deploying a high-risk AI system in the workplace
  • Public authority deployers must comply with registration obligations and verify the system is registered in the EU database before use
  • Deployers must inform affected individuals that they are subject to the use of a high-risk AI system where decisions are made about them
  • Deployers must cooperate with competent authorities in any regulatory action taken
  • Deployers must suspend use of a system they believe presents a risk and notify the relevant parties without undue delay

WHO IS AFFECTED

Every business using high-risk AI in a professional context

  • HR departments using AI for recruitment, screening or performance assessment
  • Banks and lenders using AI for credit scoring or fraud detection
  • Healthcare providers using AI diagnostic or treatment tools
  • Educational institutions using AI for student assessment
  • Public authorities using AI for benefits, social services or law enforcement
  • Any business in any sector using a third-party AI system that falls within Annex III

WHAT IT MEANS FOR SMES

The deployer checklist every SME using third-party AI needs

  • Read and retain the provider’s instructions for use — your compliance starts there; everything else builds on what the provider has specified
  • Designate a named individual responsible for human oversight of each high-risk AI system you deploy — this must be a real role with real competence, not just a job title
  • Set up log retention for at least six months from the date of each system operation — check whether your vendor’s system retains logs on their side or whether you must do it
  • If you use AI to make or support decisions about employees, customers or service users, you must inform those individuals — build this disclosure into your standard processes
  • If you are an employer deploying AI in the workplace, inform your workers and their representatives before deployment — this is a legal obligation, not optional communication
  • Your GDPR data protection impact assessment must incorporate information from the AI system’s instructions for use — coordinate your AI compliance and data protection teams
  • Suspend use immediately if you identify a risk and notify the provider first, then authorities — have a documented procedure for this before you need it

Related Articles

← Previous Art. 25 — Responsibilities Along the AI Value Chain Next → Art. 27 — Fundamental Rights Impact Assessment for High-Risk AI Systems