{"id":10750,"date":"2026-08-14T09:52:27","date_gmt":"2026-08-14T08:52:27","guid":{"rendered":"https:\/\/pkfbofidi.com\/?p=10750"},"modified":"2026-08-14T09:52:28","modified_gmt":"2026-08-14T08:52:28","slug":"european-ai-act-practical-guide-for-smes","status":"publish","type":"post","link":"https:\/\/pkfbofidi.com\/en\/european-ai-act-practical-guide-for-smes\/","title":{"rendered":"The European AI Act: a practical guide for your SME"},"content":{"rendered":"

Many SMEs nevertheless assume that they remain outside the scope of the rules as long as they do not develop AI systems themselves. That is a widespread misconception. The AI Act also expressly applies to businesses that merely use existing AI solutions in their own operations, and the resulting obligations should not be underestimated. In this article, we explain what this regulatory framework means in practice for your SME and how you can already start preparing today.<\/strong><\/p>\n

What<\/strong> is <\/strong>the<\/strong> AI Act?<\/strong><\/h2>\n

The AI Act is a European regulation designed to ensure that the development and use of AI systems within the internal market are safe, transparent and trustworthy. On the one hand, the regulation protects citizens and businesses against harmful or irresponsible AI applications. On the other hand, it creates a predictable legal framework that supports innovation. The regulation entered into force on 1 August 2024, but its obligations apply gradually.<\/p>\n

A first crucial question is when a software application qualifies as an \u201cAI system\u201d within the meaning of the regulation. The AI Act targets systems that operate with a certain degree of autonomy, can adapt on the basis of data and independently generate conclusions, predictions or recommendations. Purely rule-based software, which merely executes pre-programmed instructions without any learning or reasoning capability, falls outside the scope.<\/p>\n

What role does your business play under the AI Act?<\/strong><\/h2>\n

The regulation makes a fundamental distinction between two categories of operators. On the one hand, there are providers: organisations that design, develop or place AI systems on the market under their own name. On the other hand, there are deployers: organisations that use AI systems within their own business activities. Most SMEs fall into this second category. Even if you purchase an off-the-shelf AI solution from an external supplier, you still have your own responsibilities as a deployer. The scope of your obligations depends on the type of AI system and how you use it.<\/p>\n

Please note: your role is not necessarily fixed. If you substantially modify an AI solution, market it under your own brand name or use it for a materially different purpose than the one for which it was originally designed, you may be reclassified as a provider under the AI Act. This entails significantly heavier obligations.<\/p>\n

A risk-based approach: four levels<\/strong><\/h2>\n

At the heart of the AI Act is a classification system that categorises AI applications according to the risk they pose to people\u2019s health, safety and fundamental rights. The greater the potential impact, the stricter the applicable rules. The regulation distinguishes between four risk levels.<\/p>\n

First, there are AI systems presenting an unacceptable risk, which are prohibited outright. Examples include systems that manipulate human behaviour in a subliminal way or systems used by public authorities for social scoring. The Digital Omnibus on AI, or \u201cAI Omnibus\u201d, has also expanded the list of prohibited practices by introducing an explicit ban on AI systems that generate non-consensual sexually explicit or intimate content, so-called \u201cnudification\u201d applications, unless the provider has implemented adequate technical measures to prevent such content from being generated.<\/p>\n

Second, there are high-risk AI systems, which are used in sensitive areas such as recruitment, credit assessment, education or healthcare. This category is subject to the most far-reaching obligations. Importantly, not every application within these domains is automatically considered high-risk. Systems that merely perform a supporting or preparatory function will generally fall outside this category. In practice, however, businesses often underestimate how quickly an application may qualify as high-risk once it starts influencing decision-making processes.<\/p>\n

Third, there are AI systems with limited risk, such as chatbots, AI assistants and generative AI tools. These are mainly subject to transparency obligations: end users must always be able to clearly identify that they are interacting with an AI system or that content has been generated by AI.<\/p>\n

Fourth, there are AI systems presenting minimal risk, such as spam filters, video games or spellcheckers. These are not subject to specific obligations.<\/p>\n

It is important to understand that the same technology may fall into a different risk category depending on its specific use.<\/p>\n

Phased implementation: the AI Omnibus introduces postponements<\/strong><\/h2>\n

The obligations under the AI Act are being rolled out gradually, and the AI Omnibus has postponed several important deadlines. Since 2 February 2025, the prohibition of unacceptable AI practices has applied. Since 2 August 2025, additional rules for providers of general-purpose AI models have been in force. From 2 December 2026, the new ban on nudification AI will apply. The obligations for high-risk AI systems originally scheduled for 2 August 2026 have been postponed by the AI Omnibus: for AI systems used in risk areas such as biometrics, recruitment, education or migration, the new deadline is 2 December 2027, while obligations for AI systems embedded in regulated products, such as cars, medical devices or toys, will only become enforceable from 2 August 2028. This postponement was introduced because businesses did not have sufficient time, resources or support to meet the original deadline. In the meantime, the European Commission will publish additional guidance to simplify compliance. Despite the postponement, it remains essential to start mapping all AI systems within your organisation and to make the necessary preparations now.<\/p>\n

The sanctions for non-compliance are significant. Breaches of the prohibited AI practices may be punished with administrative fines of up to EUR 35 million or 7% of worldwide annual turnover. For other infringements, fines may reach up to EUR 15 million or 3% of annual turnover. The regulation does provide adjusted fine caps for SMEs and start-ups to ensure proportionality, but the substantive obligations apply in full, regardless of the size of the business. Notably, the AI Omnibus extends the simplifications granted by the AI Act to SMEs to so-called \u201csmall mid-cap enterprises\u201d (SMCs): businesses with between 250 and 750 employees that fall just outside the traditional SME definition. In practice, they benefit among other things from simplified documentation requirements, expectations aligned with their size and resources, and lower thresholds in supervision and enforcement.<\/p>\n

What does the AI Act expect from SMEs in practice?<\/strong><\/h2>\n

Although the regulation by no means requires every SME to bring an AI expert in-house, it does expect businesses to use AI consciously and carefully. In practice, this means that businesses acting solely as deployers should develop a structured AI policy. The core obligations can be summarised as follows: AI systems may only be used for their intended purpose; decisions that may have a significant impact on individuals must always be subject to an appropriate level of human oversight; the output of AI applications must be systematically checked for accuracy and reliability; higher-risk applications must be properly documented; and organisations should engage with their software suppliers to understand how the AI solutions they use comply with the AI regulation.<\/p>\n

As regards employees\u2019 AI literacy, the AI Omnibus has introduced an important relaxation: where the original obligation required organisations to ensure AI knowledge among all employees, this is now regarded as an obligation of means. Organisations must take reasonable measures to promote AI literacy, for example through training or information sessions, but they are no longer liable if an individual employee does not possess sufficient AI knowledge. The European Commission and the Member States will in turn provide additional support in the form of practical guidance and training materials. One particular point of attention remains that AI is increasingly embedded invisibly in existing software packages, meaning that organisations may sometimes use it without being fully aware of it.<\/p>\n

Innovation and testing environments<\/strong><\/h2>\n

An important aspect of the AI Act is the promotion of innovation. The AI Act requires Member States to set up testing environments, known as regulatory sandboxes, where businesses can develop and test their AI systems under real-world conditions, without shortcomings identified within that framework automatically leading to sanctions. The AI Omnibus goes one step further by providing for the creation of an EU-level testing environment for AI systems with a cross-border dimension. SMEs will be given priority access to this European sandbox, giving them the opportunity to develop innovative AI solutions in a controlled and legally secure environment.<\/p>\n

Five steps to start preparing today<\/strong><\/h2>\n

Waiting until the deadlines approach is not a wise strategy. Businesses that take the first steps today will be better prepared tomorrow:<\/p>\n

    \n
  1. Start with a thorough inventory of all applications within your organisation that contain AI functionalities. This means not only obvious tools such as chatbots or text generators, but also less visible AI components in existing software, such as automated screening modules in HR packages or predictive algorithms in accounting software.<\/li>\n
  2. Next, carry out a risk assessment for each application using the classification guidelines published by the EU: determine the risk level and map the potential impact on the individuals concerned.<\/li>\n
  3. Carefully assess your role and responsibilities under the regulation: are you merely deploying an AI system, or could your organisation qualify as a provider because it modifies the software or offers it to third parties?<\/li>\n
  4. Align your contracts, internal policies and documentation with the new timeline introduced by the AI Omnibus.<\/li>\n
  5. Finally, build a robust AI governance framework: define internal responsibilities, establish clear guidelines for the use of AI within your organisation and provide appropriate training and ongoing monitoring.<\/li>\n<\/ol>\n

    The European AI Regulation is now an operational reality. Some obligations already apply, and while the AI Omnibus gives businesses more time and breathing room to comply with certain requirements, the core of the AI Act remains unchanged. For SMEs using AI applications, even where these are standard third-party software solutions, this means they can no longer hide behind their limited size or the fact that they do not develop AI themselves.<\/p>\n

    Transparency, human oversight and adequate documentation are becoming the new standard, regardless of the scale of the business. Those who act on this today will not only reduce the risk of potential fines, but also position themselves as a reliable partner in a market where responsible AI use will increasingly make the difference.<\/p>\n

    Our PKF BOFIDI Legal lawyers<\/a> are here to help<\/strong><\/h2>\n

    Would you like to know how well your business is prepared for the AI Act and the AI Omnibus? Our PKF BOFIDI Legal<\/a> team will be happy to help you map your AI use, carry out a risk assessment and develop a practical, workable AI governance framework. Feel free to contact us.<\/p>\n

    For a refresher on AI regulation, you can consult our previous article<\/a>.<\/p>\n

    This article was written by Lauranne Piotrowski.<\/p>\n","protected":false},"excerpt":{"rendered":"

    Artificial intelligence is no longer the exclusive domain of tech giants or specialised software companies. Quite the opposite: AI has already become part of the day-to-day operations of many SMEs, often without attracting much attention. Think of smart accounting software that detects anomalies in expense patterns, a CRM system that automatically ranks sales opportunities, or a translation tool that speeds up international correspondence. Precisely because AI has quietly found its way into business processes, many entrepreneurs underestimate its legal implications. With Regulation (EU) 2024\/1689, better known as the AI Act, the European Union has introduced a comprehensive regulatory framework setting out clear rules for anyone developing or using AI. That framework has since been adjusted by the Digital Omnibus on AI (Regulation (EU) 2026\/1744), which introduces a number of targeted changes to make compliance with the AI Act more practical and proportionate, especially for smaller businesses.<\/p>\n","protected":false},"author":6,"featured_media":10752,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[92],"tags":[148,158,93],"class_list":["post-10750","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-legal-en","tag-pkf-bofidi-en","tag-pkf-bofidi-legal-en"],"acf":[],"yoast_head":"\nThe European AI Act: a practical guide for your SME | PKF BOFIDI<\/title>\n<meta name=\"description\" content=\"The European AI Act introduces new obligations for businesses. 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