Work Package 3 Video Guide

We are pleased to share the progress being made in Work Package 3 of the HEU-EFS consortium, dedicated to enhancing early feasibility studies (EFS) for medical devices across Europe.

We invite you to watch the video to learn more about our work and its impact.

Alexandra Poulsson from the Norwegian Institute of Public Health and the Norwegian Medical Products Agency is leading efforts to develop comprehensive eligibility criteria for EFS. Her work ensures that technologies, medical conditions, patient severity, evidence levels, clinical sites, and expertise are all meticulously evaluated to pave the way for successful studies.

Nataliya Deych, Regulatory expert at Edwards Lifesciences Europe, emphasises the importance of collaboration between industry and regulators, highlighting the critical role of patient perspectives in shaping regulatory decisions. This commitment to innovation drives efforts to bring cutting-edge clinical programmes to European stakeholders.

Carlo Federici from SDA Bocconi contributes his expertise in health economics and technology assessments. Carlo’s research focuses on analysing the current state of pre-market clinical investigations and proposing a robust framework for EFS in the EU. His work is crucial for ensuring that medical devices are evaluated with the right evidence at the right time.

Visit heuefs.eu and follow us on LinkedIn https://lnkd.in/ekMx-4mp and X https://twitter.com/HEUEFS as we advance towards a harmonised approach to early feasibility studies, ultimately enhancing patient access to innovative medical technologies.

Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe

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