You are reading part 2 of our series of articles on the EU AI Act.
In the first part of this series, we presented an overview of the EU AI Act, including the risk-based approach, the four risk levels, and the key deadlines. The framework is clear, but the implications vary greatly depending on the industry.
A product is classified as high risk based on a combination of industry, product type, and role in the AI lifecycle. A company may be both a provider of a product and a deployer of a purchased system. Now, it’s time to get specific. What does the AI Act mean for your industry?
AI-based medical devices face double regulation. Any software developed as a medical device (SaMD) in classes IIa to III is automatically considered high-risk under the AI Act via the MDR/IVDR. The key is to integrate both sets of regulations into one QMS rather than maintaining two parallel systems.
Safety-critical AI in vehicles, from driver assistance systems to autonomous driving functions, is under particular scrutiny. The EU is planning a delegated act that will supplement existing type approvals with AI-specific requirements. For OEMs and suppliers, this will create complex chains of responsibility throughout the supply chain.
Credit scoring and risk assessment of individuals are explicitly identified as high risk. The focus is on fairness and non-discrimination. AI models must not use protected characteristics as proxies for credit risk. Fraud detection systems are expressly excluded.
AI decisions about citizens, such as those related to social benefits, visa procedures, or the justice system, are considered high risk. Authorities are required to carry out a fundamental rights impact assessment. The deadline for the public sector has been extended; existing systems must be fully compliant by August 2030.
The majority of industrial AI applications, such as predictive maintenance, quality control, and production planning, fall under minimal risk. The exception: AI safety components in machines that fall under the new Machinery Regulation (EU) 2023/1230. Here, high-risk requirements apply.
All industries share the need for risk management, data governance, technical documentation, and human oversight. The regulatory frameworks and entry points differ.
No industry can ignore the AI Act. However, the entry point and priorities vary considerably.
In every industry, the journey begins with classification and inventory. However, the specific starting points vary.
sepp.med supports companies across all industries in implementing regulatory requirements, including medtech, automotive, e-government, and finance. There is no one-size-fits-all consulting approach, only industry-specific integration.
Talk to us about your industry-specific needs. We combine regulatory and technical expertise.
Tip: At the Afterwork Exchange by sepp.med, Florian Prester, sepp.med’s CEO, will share practical insights on “The EU AI Act and its impact on regulated industries: Med-Tech, Mobility, and Public.”
How does AI evolve from a buzzword to a tangible business impact? At the Afterwork Exchange, “Business Impact: AI,” you can look forward to brief, practical insights and an overview of the EU AI Act. Afterwards, there will be an opportunity to network at a get-together and dinner.
When: March 19, 2026, 5:00 p.m.Where: sepp.med in Röttenbach
For the medical technology (MedTech) industry, there is the MDCG 2025-6 guidance, which specifies the interaction between the Medical Device Regulation (MDR) and the AI Act. Delegated acts are expected for the automotive industry. Other industries are guided by ISO/IEC 42001 and the EU Commission’s general guidance documents.
It depends on the AI system in question and its intended use. A product-related classification is the right starting point, rather than an industry-related one.
Some federal states in Germany and EU programs are preparing funding opportunities for SMEs. The details are still being clarified. It is worth checking on an individual basis.
Firstname:
Lastname:
E-Mail Address:
Phone:
Subject:
Your message:
Yes, I consent to my personal data being collected and stored electronically. My data will only be used for the purpose of responding to my inquiry. I have taken note of the privacy policy.
You are currently viewing a placeholder content from OpenStreetMap. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
You need to load content from hCaptcha to submit the form. Please note that doing so will share data with third-party providers.
You are currently viewing a placeholder content from Google Maps. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.