Publications

MT13 Challenges of Pre-Market Clinical Investigations of Medical Devices: A Multi-Stakeholder Perspective

Callea, Giuditta et al., Value in Health, 28 (6), S268, July 2025, https://doi.org/10.1016/j.jval.2025.04.1123

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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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Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: A Qualitative Interview Study

Peseke M., Michaelis I., Kayembe O., Geraghty M., McDonnell A., Zurlo F., Oftring Z., Martelli N., Melvin T., Kuhnn S.
JMIR – Journal of Medical Internet Research, JMIR Publications Inc, October 2025, 10.2196/77982

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