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The EU AI Act for mid-sized companies: don't wait for the high-risk deadline.

Governance sits as a review step right before approval.

A draft, whether written by a person or a model, goes through a review step against rules and law. If it breaks a rule it goes back, otherwise approval follows. Content for healthcare clients is also checked against German health advertising law.

Most mid-sized companies are deployers under the EU AI Act, and for them two duties matter most today: AI literacy among staff and transparency for published content.

If you are waiting for December 2027, you are waiting for high-risk obligations that, after the July 2026 amendment, start then and cover only certain uses, such as recruiting or credit scoring. AI governance belongs at the points where a result leaves the company and where cost is incurred. The European framework is Regulation (EU) 2024/1689.

Updated Deutsche Fassung

In an agency's daily work, our clients' industry rules often affect us more directly than the AI Act. So I put governance into the workflows as a review step, at the point right before approval.

Carl-Uwe Würfel, COO & Chief AI Officer

The AI Act entered into force on August 1, 2024 and applies in stages. Since February 2, 2025, certain practices are banned, and Article 4 requires AI literacy among staff. Since August 2, 2025, obligations apply to providers of general-purpose AI models. They usually fall on the model providers, not their users. Since August 2, 2026, the regulation applies in general, including the transparency obligations under Article 50. The amending Regulation (EU) 2026/1744, known as the AI Omnibus, has been in force since July 27, 2026. It moves the high-risk obligations to December 2, 2027 (August 2, 2028 for AI in regulated products). From December 2, 2026, AI systems that generate intimate images of real people without consent or child sexual abuse material are also banned. So AI literacy and transparency apply today; high-risk obligations only from December 2027.

AI literacy and transparency apply today; high-risk obligations only from December 2027.

The EU AI Act timeline from the view of a company that uses AI: since February 2025, bans on certain practices and AI literacy under Article 4 apply, which affects every company using AI. Since August 2025, obligations apply to providers of general-purpose AI models and usually fall on the model providers. Since August 2026, the transparency obligations under Article 50 apply: label deepfakes and disclose AI-generated text on matters of public interest unless a person reviewed it and someone holds editorial responsibility. High-risk obligations apply from December 2027, for example in recruiting or credit scoring, and from August 2028 for AI in regulated products. As of November 2026, Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744.

The regulation separates providers, who develop an AI system and place it on the market or put it into service under their own name, from deployers, who use it under their own authority. Most companies and agencies are deployers. If you offer a system under your own name or substantially modify a high-risk system, you can become a provider yourself. Next comes the classification of each application: prohibited practices, high-risk systems (for example in recruiting or credit scoring), systems with transparency obligations, and minimal-risk systems. The AI Act does not generally require deployers to keep a register of all applications. Without such an overview, though, none of these questions can be answered. It should also cover AI features in standard software and chat services that employees use on their own.

Article 4 affects every company that uses AI, regardless of risk class. Since the July 2026 amendment, they must take measures that support the development of AI literacy among their staff. They do not have to guarantee a specific level for each person. The duty remains, but it asks for measures rather than a provable result. At SUMAX we built a training program around real tasks from each team's own work, and we rewrote the role descriptions. Whoever passes on an AI result unchecked is just forwarding output. Generic examples don't show anyone where errors arise in their own workflow.

For deployers, two transparency duties in Article 50(4) matter most. Deepfakes, meaning AI-generated or manipulated images, audio and video that falsely appear authentic, must be clearly labeled. AI-generated text that informs the public on matters of public interest must be disclosed. That duty does not apply if a person has reviewed the content and someone holds editorial responsibility for the publication. According to the Commission, public health counts as such a matter, and a spell check is not enough of a review. Before approval, we already check content for healthcare clients against German health advertising law, the Heilmittelwerbegesetz, whether a person or a model wrote the draft. If a draft breaks a rule, it goes back. The GDPR still applies alongside the AI Act.

Governance includes money. At SUMAX every AI call from our own applications runs through a dedicated layer between the applications and the AI models and is logged with its cost. Roles and permissions set who may use which model and which data. Budgets cap the spend. The same layer lets us switch models without rebuilding the applications. The foundation for everyone came first: users, permissions and access, with security built in from the start. Tools for individual tasks came after that.

A checklist for leadership, not legal advice. One: is it clear for each application whether the company is a deployer or a provider? Two: is there an overview with purpose, data, role and risk class, including AI in standard software and chat services? Three: does the team learn on the tasks whose results it later reviews? Four: does someone check before publishing whether a deepfake needs a label or AI-generated text needs disclosure? Five: is it settled who may use which model and which data, and what each application costs? Every no is an open item. Classifying a specific system is a job for IT law specialists.

Frequently asked questions

Does all AI-generated text have to be labeled?

No. Article 50(4) requires disclosure for published AI-generated text that informs the public on matters of public interest, and the Commission counts public health among them. The duty does not apply if a person has reviewed the content and a person or company holds editorial responsibility for the publication. According to the Commission, a spell check alone is not enough. Deepfakes must be labeled regardless.

Is a company that uses AI tools a provider or a deployer?

Usually a deployer. Using someone else's model in your own workflow makes you a deployer. If you place a system on the market under your own name or substantially modify a high-risk system, you can become a provider yourself.

Do employees have to be trained?

Yes, to a reasonable degree. Since February 2025, Article 4 has required companies that use AI to take measures for their staff's AI literacy, even without any high-risk application. The July 2026 amendment clarifies that they do not have to guarantee a specific level for each person. Training works best on the tasks whose results staff will review later.

Does a company need an AI officer?

The AI Act does not require an AI officer. GDPR duties, such as appointing a data protection officer, are unaffected. It still makes sense to assign clear responsibility for the overview of applications and for open questions on classification.

What fines apply, and who enforces the AI Act in Germany?

Up to 35 million euros or 7 percent of worldwide annual turnover for prohibited practices, and up to 15 million euros or 3 percent for breaches of many other obligations, including the transparency rules; the higher amount applies. For small and medium-sized enterprises the lower amount applies, and since July 2026 the same holds for small mid-cap companies, except for breaches of the prohibitions. Germany's central supervisory authority has been the Federal Network Agency (Bundesnetzagentur) since July 29, 2026; other authorities remain responsible for certain areas such as financial services.

Does this page replace a legal review?

No. It describes the state of play in November 2026 and how we organize governance in daily operations. Classifying a specific system is a job for IT law specialists, based on the current version of the regulation.

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