Other Materials

Newsletters

Issue #2 June 2025

Issue #1 November 2024

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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

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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.

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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.

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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.