The EU AI Act by industry

You are reading part 2 of our series of articles on the EU AI Act.

• Part 1 – The EU AI Act in 2026: What every company using AI software needs to know now
• Part 2 – The EU AI Act by industry: What distinguishes the medtech, automotive, finance, and administrative sectors?

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?

Common challenge, different levers

All industries share the need for risk management, data governance, technical documentation, and human oversight. The regulatory frameworks and entry points differ.

• In the medical technology sector, the goal is to integrate the AI Act into the existing MDR QMS, creating an extension rather than a duplicate structure.
• In the automotive sector, a reliable assessment will only be possible once the delegated acts have been published.
• Financial service providers face the challenge of demonstrating the explainability and fairness of their AI models.
• Public administration often lacks resources and technical expertise while dealing with particularly sensitive applications.
• Industry benefits from an established safety culture but must incorporate the new AI-specific requirements into existing processes.

No industry can ignore the AI Act. However, the entry point and priorities vary considerably.

The right entry point for your industry

In every industry, the journey begins with classification and inventory. However, the specific starting points vary.

• MedTech companies should use their existing MDR QMS as a starting point for AI Act integration.
• Automotive companies benefit from creating an AI inventory early on and separating safety-critical systems from non-safety-critical ones.
• Financial services providers should review their credit scoring and pricing models for fairness and explainability.
• Government agencies are best off starting with a use case inventory and a fundamental rights impact assessment.
• Industrial companies can use their existing safety processes as a bridge to AI Act compliance.

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.

Sources

• Regulation (EU) 2024/1689 – Full text (English) – Official legal text in the Official Journal of the EU
• European Commission – AI Act: Regulatory Framework – Official overview page of the Commission on the AI Act with deadlines and implementation status
• European Commission – Standardization of the AI Act – Official information page on harmonized standards (CEN/CENELEC) and their role in AI Act compliance
• ISO/IEC 42001:2023 – AI Management Systems – Official ISO page on the world’s first standard for AI management systems
• MDCG 2025-6 – Interplay between MDR/IVDR and the AI Act (PDF) – Official FAQ guidance from the Medical Device Coordination Group on the interplay between MDR/IVDR and the AI Act for AI medical devices (MDAI)
• European Commission – Guidelines for providers of general-purpose AI models – Official Commission guidelines on the interpretation of GPAI obligations (applicable from August 2025)