During the 10th International Conference on Smart and Sustainable Technologies, SpliTech 2025 in Split, the EU4MEDTECH project was presented, with a focus on its objectives, methodological approach, and the work that will be undertaken in the coming years.
Within the conference section dedicated to health technologies, Ružica Bandić, DMD, from the University of Split School of Medicine, delivered a presentation titled “Streamlining EU Regulatory Processes for High-Risk and Innovative Medical Devices and In Vitro Diagnostic Medical Devices.”
The presentation addressed key challenges and opportunities within the current European regulatory framework, particularly in the context of implementing the MDR and IVDR regulations.
Special emphasis was placed on the work of the EU4MEDTECH project, which brings together 14 partners from 10 EU countries, intending to develop a digital framework for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices. The presentation outlined elements of the pre-study phase, including an extensive analysis of evidence-generation methodologies, a review of regulatory requirements, and an evaluation of digital solutions supporting EU regulatory compliance.
The presentation also demonstrated how the project aims to improve regulatory processes through:
- a new framework for evidence generation and evaluation,
- recommendations for new Common Specifications,
- and a digital platform that will include a regulatory communication channel, a global regulatory search tool, EUDAMED training modules, and a shared data repository.
The activities presented highlight the potential of the EU4MEDTECH project to contribute to faster and more efficient market access for innovative medical technologies, greater transparency, and improved alignment of regulatory and HTA processes across the European Union. Supported by advanced digital technologies and real-world data sources, these efforts pave the way for safer, more effective, and more sustainable development of health innovations.
