> For the complete documentation index, see [llms.txt](https://docs.assenteo.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.assenteo.com/ai-and-data-protection/obligations-for-high-risk-systems.md).

# Obligations for High-Risk Systems

### How are obligations for high-risk AI systems different from limited-risk systems?

The technical and **operational requirements** the AI system must satisfy are detailed in **Articles 8-15** of the **EU AI Act.**&#x20;

These include:&#x20;

* risk management;
* data governance;
* logging;
* human oversight; and&#x20;
* technical documentation.

The **responsibilities of the businesses** involved throughout the AI system’s lifecycle (providers, deployers, importers and distributors) are detailed in **Articles 16-29** of the **EU AI Act**.

These include:&#x20;

* conformity assessments;
* quality management systems;
* post-market monitoring; and&#x20;
* incident reports.

Additional obligations apply to specific sub-categories of high-risk AI systems such as biometric identification and categorisation systems and law enforcement systems.

\
Note that limited risk systems do not have as many obligations attached to them as high risk systems. The obligations around **limited risk systems** centre on **disclosure and employee AI literacy**.&#x20;

### What are the penalties for non-compliance?

Non-compliance with the obligations relating to high-risk AI systems (other than prohibited practices) can result in fines of up to EUR 15 million or 3% of total worldwide annual turnover for the preceding financial year, whichever is higher or, in the case of SMEs, whichever is lower.&#x20;

The Act refers to the EU Commission’s definition of SMEs. This details that a ‘medium-sized’ enterprise must have:&#x20;

* Fewer than 250 employees; and&#x20;
* An annual turnover of under 50 million euros/ under 43 million euros on their annual balance sheet.

The risks are not only financial; non-compliance with the EU AI Act’s provisions on high-risk AI systems could lead to significant reputational damage, loss of user trust and therefore loss of profits.

### Practical next steps

**Appointing an AI Compliance Lead**

If you believe your AI system qualifies as 'high-risk', you might consider appointing an AI Compliance Lead to assist in ensuring continuous regulatory compliance.&#x20;

An AI Compliance Lead eases compliance burdens related to:

* continuous risk management;
* high data governance standards;
* preparation and maintenance of technical documentation (including design specifications and performance testing);
* conformity assessments;
* quality management systems; and
* coordinating with providers and other third-parties involved in the model’s lifecycle.&#x20;


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