European industry representatives are urging policymakers to reconsider parts of the EU AI Act, arguing that the current framework could impose significant compliance costs on companies developing AI tools for industrial and medical technologies.
According to Cecilia Bonfeld-Dahl, director-general of DIGITALEUROPE, manufacturers of high-tech machines, medical devices, and radio equipment are already subject to strict product safety regulations. Adding AI-specific requirements could create unnecessary administrative burdens for companies already heavily regulated. She argues that policymakers should aim for balanced AI regulation that encourages innovation while maintaining safety standards.
Industry groups warn that classifying certain AI systems as high-risk under Annex I of the AI Act could be particularly costly for smaller firms. DIGITALEUROPE estimates that a company with around 50 employees developing an AI-based product could incur initial compliance costs of €320,000 to €600,000, followed by annual expenses of up to €150,000. According to the organisation, such costs could reduce profits significantly and discourage smaller companies from pursuing AI innovation.
Manufacturing and medical technology sectors across Europe employ millions of workers and increasingly rely on AI to improve product performance and safety. Industry representatives argue that many applications, such as AI systems used to enhance industrial equipment safety or improve medical devices, already operate under established regulatory frameworks. These existing frameworks could be adapted rather than introducing additional layers of regulation.
The broader regulatory landscape is also contributing to concerns among technology companies. Over the past six years, the EU has introduced nearly 40 new technology-related regulations, some of which overlap or impose similar compliance requirements. DIGITALEUROPE estimates that compliance with the AI Act could cost companies approximately €3.3 billion annually, while cybersecurity and data-sharing regulations add further financial obligations.
Industry leaders warn that rising compliance costs could affect investment in AI development across Europe. Current estimates suggest that the EU accounts for about 7.5% of global AI investment, significantly behind the United States and China.
DIGITALEUROPE has called on the EU institutions to consider postponing parts of the AI Act’s implementation timeline to allow further discussion on how high-risk AI systems should be defined. Supporters of this approach argue that additional consultation could help ensure the regulatory framework protects consumers while also enabling European companies to compete globally in the rapidly evolving AI sector.
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