Other Materials

Newsletters

Issue #2 June 2025

HEU-EFS Newsletter_June 2025 Download

Issue #1 November 2024

HEU-EFS Newsletter_November 2024 Download

Project featured in Journals

Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table

Stephan Windecker; Alan G. Fraser; Piotr Szymanski; Martine Gilard; Thomas F. Lüscher; Leila Abid; John Brennan; Robert Byrne; Lia Crotti; Inga Drossart; Jennifer Franke; Mario Gabrielli Cossellu; Ajay J. Kirtane; Jana Kurucova; Mitchell Krucoff; Gearóid McGauran; Patrick O. Myers; Donal B. O’Connor; Radosław Parma; Paul Piscoi; Archana Rao; Andrea Rappagliosi; Giulio Stefanini; Eigil Samset; Alphons Vincent; Ralph Stephan von Bardeleben; Franz Weidinger
European Heart Journal, 46 (16), April 2025, Pages 1469–1479, https://doi.org/10.1093/eurheartj/ehaf069

Background Publications

An Accelerated Access Pathway for Innovative High-Risk Medical Devices under the New European Union Medical Devices and Health Technology Assessment Regulations?

Tarricone, R.; Banks, H.; Ciani, O.; Brouwer, W.; Drummond, M. F.; Leidl, R.; Martelli, N.; Sampietro-Colom, L.; Taylor, R. S. Analysis and Recommendations.
Expert Review of Medical Devices, 20 (4), 1–13, April 2023, https://doi.org/10.1080/17434440.2023.2192868.

Recommendations for the Design and Implementation of an Early Feasibility Studies Program for Medical Devices in the European Union.

Callea, G.; Federici, C.; Freddi, R.; Tarricone, R.
Expert Review Medical Devices, 19 (4), 1–11, May 2022, https://doi.org/10.1080/17434440.2022.2075729.

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective.

Tarricone, R.; Ciani, O.; Torbica, A.; Brouwer, W.; Chaloutsos, G.; Drummond, M. F.; Martelli, N.; Persson, U.; Leidl, R.; Levin, L.; Sampietro-Colom, L.;
Expert Review of Medical Devices 2020, 17 (10), 993–1006, October 2020, https://doi.org/10.1080/17434440.2020.1825074.

Videos

Introducing HEU-EFS

Andrea Rappagliosi (Edwards Lifesciences Europe)
Rosanna Tarricone (SDA Bocconi)

HEU-EFS Annual Consortium Meeting in Geneva

Andrea Rappagliosi (Edwards Lifesciences Europe)
Rosanna Tarricone (SDA Bocconi)
Annette Brüls (Edwards Lifesciences Europe)

International Women’s Day

Advancing Gender Equality in Healthcare: Insights from Leading Experts

Dr. Laura Sampietro-Colom (Hospital Clínic de Barcelona)
Cinzia Santin (W. L. Gore & Associates)

Patient Advisory Group

Massimo Russo – Italy: Cardiovascular patient
Tamool M. – Egypt: Type 1 Diabetes patient
Christian Pfeuffer – Germany: Spinal Muscular Atrophy Patient

Patient Associations

Yasemin Zeisl (European Patients’ Forum)
Marta Bragagnolo (Global Heart Hub)

World Telecommunication and Information Society Day

Advancing Early Evidence for Health Technology Innovations

Sebastian Kuhn (Philipp University of Marburg)

Early Feasibility Studies at the MedTech Forum 2025

Niklas Blomberg (Innovative Health Initiative – IHI), Rosanna Tarricone (SDA Bocconi), Alexandra Poulsson (Norwegian Institute of Public Health), Yasemin Zeisl (European Patients’ Forum), Fanny van der Loo (Edwards Lifesciences Europe), Laura Sampietro-Colom (Hospital Clínic de Barcelona).