EU4MEDTECH

Transforming the evaluation of high-risk medical devices and diagnostics in Europe.

EU4MEDTECH revolutionises the generation and evaluation of clinical and performance evidence for high-risk, innovative medical devices (MDs) and in vitro diagnostic devices (IVDs) by co-creating and validating the versatile and lifecycle-oriented EU4MEDTECH framework.

This framework addresses the challenges posed by the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which, while ensuring higher patient safety, have increased regulatory burdens for stakeholders across the HealthTech value chain.

The EU4MEDTECH framework will be operationalised through an interactive, cloud-based digital platform and validated across three use cases: class III and implantable medical devices, class C/D in vitro diagnostic devices, and software-based medical and diagnostic devices, with clinical studies conducted for highly innovative solutions.

Key MedTech stakeholders are actively engaged in co-design processes to ensure the project outcomes are applicable, scalable, and sustainable. Furthermore, the project will develop a comprehensive exploitation roadmap for widespread adoption and long-term impact.

Eurecat participates in EU4MEDTECH through its IT&OT Security Unit, by defining a knowledge graph to help the development of safe medical devices. Moreover, it develops the necessary tools to exploit this knowledge, not only in the design, but also during the life cycle of connected medical devices.

The EU4MEDTECH consortium brings together expertise in MD/IVD regulations, clinical sciences, computer science, cybersecurity, health economics, and business acceleration.