Experts warn of the impact of the EU AI Act on medical laboratories and call for the development of AI skills. The regulation, which has been in force since August 2024, will require providers and operators of AI systems to ensure that their staff is sufficiently qualified, taking into account knowledge, experience and deployment context, from February 2025.

The Act applies to all AI systems used in the EU, regardless of origin, with exceptions for private use, research and national security. In laboratories, systems must be individually tested to see if they fall under the broad definition, which includes machine systems with autonomy and adaptability. Rule-based software, as is common in laboratory information systems, is likely to be exempt.

There are overlaps with medical device regulations; certain in vitro diagnostics are considered high-risk AI, but not in-house devices. The authors emphasize that interpretations are preliminary and await judicial clarification.

Basic data literacy is recommended as the basis for AI literacy, including dataset building, preprocessing, visualization, and data protection. Training should cover the EU AI Act, AI fundamentals such as machine learning, deep learning, and generative models, as well as context-specific content on systems, risks, and evaluation.

Violations can result in fines for high-risk systems, civil and criminal consequences for patient harm, and liability issues for users. The experts recommend training to meet the requirements.

Important details can be seen as posters at the DKLM 2025 in Leipzig. Interested media can receive the poster in advance in compliance with the strict embargo period of 23.10.2025 / 00:01 and presentation of a valid press card. To do so, send us your enquiry including a copy of your press card to: redaktion@medlabportal.de

The German Congress of Laboratory Medicine (DKLM) 2025 promises exciting insights into the interface between science and clinical practice. Under the motto “Science for Precision Medicine”, the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) and the Umbrella Association for Technologists and Analysts in Medicine Germany (DVTA) invite experts from research, clinics and industry to meet on October 23 and 24 at the Congress Center Leipzig (CCL). The two-day event is aimed at laboratory physicians, biomedical analysts and decision-makers to discuss current advances in diagnostics and strengthen networks. The ceremonial opening of the congress will take place on 22 October with the presentation of the MedLabAwards in the Salles de Pologne.

Editor: X-Press Journalistenbüro GbR

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