Customer story
EU4MEDTECH to address challenges in medical technology regulation in the EU
"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.
Customer story in numbers
7.7
M€
4
Years
14
Partners
10
Countries
Funding instrument
Horizon Europe
EU4MEDTECH project aims to develop a versatile and 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) across pre- and post-market stages. 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.
Key challenges
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. This regulatory update also presents challenges affecting all stakeholders across the EU MedTech value chain. The extended approval times may delay the introduction of new MDs and IVDs to the market and increase the risk that devices previously approved under the old Directives will be withdrawn.
How we reached the goals
Spinverse funding experts in the health domain provided their expertise on the complex funding process and consortium building to secure the successful outcome of the proposal.
Key takeaways
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 benefiting patients and MedTech stakeholders across the EU.
Impact of the project
Ensuring a timely patient access to new and safe innovations in medical devices and in vitro diagnostics.