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14 July 2025

BDO Legal Guide To The New Artificial Intelligence Regulation (AI Act)

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BDO Malta

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Forming part of BDO’s Global Network, BDO Malta is a professional services and advisory firm, assisting companies in accelerating business growth through exceptional client service. Established in 1978, BDO Malta provide a wide portfolio of services including regulatory advisory, outsourcing, audit and assurance, tax & technology regulatory compliance to assist clients across different industries in growing their businesses efficiently.
Regulation (EU) 2024/1689, establishing rules on artificial intelligence (hereinafter referred to as the "Regulation" or "AI Act"), represents a milestone in the regulation of emerging technologies.
Malta Technology

Regulation (EU) 2024/1689, establishing rules on artificial intelligence (hereinafter referred to as the “Regulation” or “AI Act”), represents a milestone in the regulation of emerging technologies. It ensures that  Artificial Intelligence (hereinafter, “AI”) is developed and used in a safe and ethical manner within the European Union, while simultaneously supporting technological innovation without imposing unnecessary restrictions.

Who does it apply to? The AI Act applies to all organisations within the European Union, as well as foreign entities that intend to use, develop, or market AI products in the EU market.

Only certain areas are excluded, such as military, defence, national security, scientific research, and purely personal activities, among others.

What is meant by Artificial Intelligence? An AI system is defined as any machine-based system that operates autonomously and learns from its environment.

Any company may assume one of the following two main roles in relation to an AI system:

  • Developer/Provider of the system: the company or individual who develops and offers the AI system.
  • Deployer: the entity that uses or implements an AI system within its organisation.

What obligations does the AI Act impose? The AI Act classifies AI systems according to their risk level. Systems deemed high-risk must comply with stricter requirements to ensure safety and reliability, whereas low-risk systems are subject to more flexible obligations.

It also introduces a list of prohibited practices which will be banned within the European Union six months after the Regulation enters into force.

Obligations vary depending on the company's role regarding the AI system (provider or deployer), and include: notifying and registering AI systemsconducting conformity assessmentsdrafting and approving internal use policiesinforming users about the AI systemensuring product and creating supervisory authorities and regulatory sandboxes, among others.

Want to know more? To support understanding, we are pleased to present the “BDO Legal Guide to the New Artificial Intelligence Regulation (AI Act) and Its Impact on Companies”, which outlines the range of services through which  BDO Legal can assist companies in efficiently adapting to this regulation.

DOWNLOAD THE GUIDE

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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