---
title: "EU AI Act — Definition | QbD Group"
description: "The European regulation on artificial intelligence, applying a risk-based framework. AI-enabled medical devices and IVDs generally fall in the high-risk..."
url: https://qbdgroup.com/en/knowledge-center/glossary/eu-ai-act
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"EU AI Act — Definition | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary/eu-ai-act"
---

[Back to the glossary](https://qbdgroup.com/en/knowledge-center/glossary) Regulatory Glossary

# EU AI Act

Devices & Software

## Definition

The European regulation on artificial intelligence, applying a risk-based framework. AI-enabled medical devices and IVDs generally fall in the high-risk category, adding requirements on data governance, transparency, human oversight, robustness, and post-market monitoring on top of MDR or IVDR.

## Related terms

[SaMDSoftware intended for a medical purpose that performs that purpose on its own, without being part of a hardware device. Under MDR and IVDR it is qualified and classified in its own right, with clinical evidence, usability, and cybersecurity requirements.](https://qbdgroup.com/en/knowledge-center/glossary/samd)[IEC 62304The standard defining the software development lifecycle for medical device software: safety classification A to C, planning, requirements, architecture, verification, configuration management, problem resolution, and maintenance after release.](https://qbdgroup.com/en/knowledge-center/glossary/iec-62304)[ISO 14971The standard for applying risk management to medical devices across the lifecycle: risk analysis, evaluation, control, evaluation of overall residual risk, and production and post-production information feeding back into the risk file.](https://qbdgroup.com/en/knowledge-center/glossary/iso-14971)[CybersecurityFor regulated devices, the set of design and process controls protecting confidentiality, integrity, and availability, as described in MDCG 2019-16. It spans secure design, threat modelling, vulnerability handling, and security updates over the supported lifetime.](https://qbdgroup.com/en/knowledge-center/glossary/cybersecurity)

## Need more than a definition?

Our regulatory, quality, and clinical specialists turn these requirements into working submissions, systems, and studies.

[Explore our services](https://qbdgroup.com/en/services)[Talk to an expert](https://qbdgroup.com/en/contact)

---

Source: https://qbdgroup.com/en/knowledge-center/glossary/eu-ai-act — © QbD Group. Quote freely with attribution and a link back.