Horizon Europe awards EUR 7.7 million to EU4MEDTECH project to address EU regulatory challenges while advancing innovation and patient safety

Spinverse’s Digital Health team supported the preparation of EU4MEDTECH project, an ambitious Horizon Europe initiative. It aims at developing a versatile life cycle framework for the generation and evaluation of clinical and performance evidence of high-risk, innovative Medical Devices (MDs) and In Vitro Diagnostics (IVDs) in pre- and post-market.

The developed framework will be operationalised through a state-of-the-art digital platform that will streamline regulatory processes, improve collaboration along the MedTech value chain, and ultimately enable faster patient access to innovative and safe MDs and IVDs. 

Aiming to streamline EU regulatory environment for Medical Devices and In Vitro Diagnostics

With over 500 000 commercialised MDs and IVDs, the EU MedTech market is the second biggest worldwide.The Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) have been recently introduced – replacing previous MD and IVD Directives – to strengthen the EU regulatory framework and to ensure the highest levels of patient safety. However, this regulatory update also presents challenges affecting all stakeholders across the EU MedTech value chain: from MD and in IVD companies to regulatory bodies, patients, and healthcare systems. For instance, the extended approval timelines are delaying the introduction of new MDs and IVDs to the market and increasing the risk that devices previously approved under the old Directives will be withdrawn. This, in turn, hinders patients' timely access to new and safe innovations and affects the availability of both old and new technologies.

EU4MEDTECH brings together 14 entities from 10 European countries

To address these significant real-world challenges faced by MedTech stakeholders and to increase patient safety while promoting MedTech innovation, 14 entities from 10 EU countries will drive EU4MEDTECH project over the next 4 years with a budget of EUR 7.7 million granted by Horizon Europe. (Call ref: HORIZON-HLTH-2024-IND-06-08).

Picture 1: Countries participating in the EU4MEDTECH project.

The project intends to demonstrate, through its three use cases, how EU4MEDTECH framework can effectively streamline regulatory processes, enhance and harmonise clinical and performance evidence generation and evaluation, and improve the integration of innovative MDs/IVDs into healthcare systems, ultimately benefitting patients and MedTech stakeholders across the EU. The initiative will also seek to integrate Real-World-Data and registries into a continuous lifecycle assessment, deliver guidelines for the inclusion and evaluation of Artificial Intelligence and Machine Learning technologies in MDs/IVDs (including cybersecurity measures), and provide a holistic strategy for evidence generation and evaluation that captures all stages of evidence production. Finally, the EU4MEDTECH consortium will develop a digital platform to operationalise EU4MEDTECH framework and offer a centralised means for regulatory information, submission procedures, and compliance management. This platform will be instrumental in facilitating efficient navigation through the regulatory landscape and in ensuring that all MedTech stakeholders have access to up-to-date, comprehensive guidance and resources on regulatory requirements.

 Spinverse supported the successful proposal preparation process

The EU4MEDTECH project consortium is led by Prof. Ana Marušić, MD, PhD, Chair of the Department of Research in Biomedicine and Health at the University of Split – School of Medicine (Croatia). The project had its kick-off at the beginning of December 2024.

Spinverse funding experts in the digital health domain provided their expertise on the complex funding process and consortium building to secure the successful outcome of the proposal. Prof. Ana Marušić says: “Our collaboration with Spinverse helped us shape our ideas into a comprehensive and innovative proposal and bring out the best from the outstanding expertise of all partners. Spinverse was always there to answer technical and administrative questions about the proposal application process. We have learned a lot and are more confident in our chances for future project applications.”

Spinverse’s Project Manager Simona Dell’Angelo-Scacchi, who led the proposal preparation and application process, along with the project team who were managing the EU4MEDTECH preparation, are extremely proud of the successful outcome. Simona concludes: “It was a pleasure to be part of EU4MEDTECH preparation process. It has been a rewarding experience aligning the needs of diverse stakeholders to create a more efficient regulatory environment. This successful outcome demonstrates the potential of collaboration between researchers, industry, and regulators working towards a common goal. I am extremely glad about the positive results and looking forward to following EU4MEDTECH developments and impact over the next 4 years.”

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