The Technology and Methods Platform for Networked Medical Research (TMF e.V.), together with the Association of Medical Faculties (MFT), the Association of University Hospitals in Germany (VUD) and other medical societies and associations, has published a detailed statement on the revision of the European Regulations for Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR). The proposals aim to ensure patient safety while promoting innovation and research opportunities in university medicine.

The current regulations mainly hinder translational research and the use of digital technologies such as artificial intelligence (AI) in medical practice. The participants therefore advocate practice-oriented changes, including an improved classification of software as a medical device and an adapted risk classification. They are also calling for adjustments to the requirements for clinical trials and the tracking of medical devices in use.

Particular emphasis is placed on the need for a risk-based assessment of software and AI systems in order to relieve low-risk systems of unnecessary bureaucratic burden. As a result, AI applications could more effectively contribute to relieving the burden on staff in hospitals and in the healthcare sector.

The University Medical Center is seen as a central incubator for innovative solutions that requires a protected framework for development and testing. To this end, the regulations on self-production of products and corresponding studies in the ordinances are to be adapted.

The statement was written as part of a project funded by the Federal Ministry of Research, Technology and Space (BMFTR) on the Medical Informatics Initiative. It outlines concrete measures to reconcile regulation, patient safety and innovation, and aims for a research-friendly and practical European regulatory framework that strengthens Europe’s position as a leading location for medical research and development.

Editor: X-Press Journalistenbüro GbR

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