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EU4MEDTECH: Addressing challenges of medical technology regulation in the EU

EU4MEDTECH project aims to develop a versatile and life cycle framework for generating and evaluating clinical and performance evidence of high-risk, innovative Medical Devices (MDs) and In Vitro Diagnostics (IVDs) across pre- and post-market stages.

EU4MEDTECH: Addressing challenges of medical technology regulation in the EU
€7.6 m


in funding

4 


years

14


partners 

10


countries 

Key numbers

About the project


The EU4MEDTECH project intends to demonstrate, through its three use cases, how the 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 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.


Impact of the project:

Ensuring a timely patient access to new and safe innovations in medical devices and in vitro diagnostics.

  Funding instrument     Horizon Europe  


Spinverse’s role


Spinverse funding professionals in the health domain provided their expertise on the complex funding process and consortium building to secure the successful outcome of the proposal. 



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​.

Prof. Ana Marušić, Chair of Department, University of Split – School of Medicine

  Supporting the UN Sustainable Development Goals​

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