With the entry into force of the EU AI Act on 1 August 2024 and the specific applicability of Article 4 since 2 February 2025, providers and operators of AI systems in medical laboratories are obliged for the first time to systematically ensure the AI competence of their staff. Specifically, laboratories are required to have comprehensive knowledge of the AI technologies used – this applies to technical, legal and contextual aspects.

According to the EU AI Act, all AI systems used in the European Union are subject to the new rules, regardless of the country of origin. Exceptions only exist in the case of exclusively private or pure research use and in the case of questions of national security. The decisive factor for laboratory medicine is the distinction between classic rule-based software systems and real AI applications, whereby the scope of application is based on a broad but clearly defined AI definition. In particular, in vitro diagnostic devices of classes A to D, which fall under the IVDR and whose conformity assessment requires a notified body, are considered high-risk AI systems and are subject to stricter requirements. In-house developed systems are often exempt from this.

AI competence is particularly relevant under labour law with regard to liability and due diligence obligations: Although the EU AI Act itself does not provide for explicit fines for violations of the AI competence obligation, special regulations can apply to high-risk systems – for example, if inadequate training leads to incorrect results or even patient harm. In this case, national civil and criminal law norms, such as those from the Civil Code (BGB) or the Criminal Code (StGB), are used.

The authors of the article warn that there are currently no uniform requirements for the content of training courses. Therefore, they recommend focusing on individually tailored and application-oriented training measures based on data and AI competence. The aim is to create expertise to ensure legal certainty and medical benefits in the use of AI systems and to fully exploit the potential of the technology for laboratories and patients.

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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