Publications

MT58 Use of Early Feasibility Studies to Inform Development of Medical Devices

C Federici, FL Zurlo, R Tarricone, G Callea
Value in Health, 27 (12), S497, December 2024, 10.1016/j.jval.2024.10.2528

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HPR98 The EU Regulatory Framework for Medical Device Early Feasibility Studies: What Do We Know to Date?

T Melvin, N Martelli, S Kuhn, O Tangila, Kayembe, I Michaelis, M Peseke, A McDonnell, F Murphy∙ M Geraghty, H Banks, G Callea, R Tarricone
Value in Health, 27 (12), S294, December 2024, 10.1016/j.jval.2024.10.1524

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HPR67 Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization Across 55 Jurisdictions.

Malandrini FB, Callea G, Tarricone R, Kerstan M, Sampietro-Colom L, Valledor A, Balsamo A, Catania D, Vainieri S, Tocchi M, Tangila Kayembe O, Melvin T, Poulsson A, Kuhn S, Rappagliosi A, Auclair P, Gielkens M, Santin C, Roijers R, Kvistgaard Jensen L
Value in Health, 27 (12), S288, December 2024, 10.1016/j.jval.2024.10.1494

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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.

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