Presentations

HEU – EFS Summary

HEU_EFS_Executive_SummaryDownload

ISPOR Europe, November 2025

HEU-EFS_Maria Luisa Buzelli, Andrea RappagliosiDownload

Clinical Investigations WG MD, 26 November 2025​

HEU-EFS_Giuditta Callea, Fanny van der Loo, Marta KerstanDownload

MDCG CIEPSE Working Group, 13 November 2025​

HEU-EFS_Giuditta Callea, Alexandra H.C. Poulsson, Tom MelvinDownload

RIS4SEB Consortium meeting, Milan, 9 September 2025​

HEU-EFS_Giuditta Callea, Francesca PissarelloDownload

HTA Conference, 2 July 2025

HEU-EFS_Giuditta CalleaDownload

FutureTrials 25, 17 June 2025

HEU-EFS Tom Melvin Download

EORS, 16 – 19, June 2025

HEU-EFS_Marta Bragagnolo and Yasemin Zeisl Download

EORS, 16 – 19, June 2025

HEU-EFS Thomas M Randau Download

EORS, 16 – 19, June 2025

HEU-EFS_Susan PartridgeDownload

EORS, 16 – 19, June 2025

HEU-EFS_Ana Matos MachadoDownload

EORS, 16 – 19, June 2025

HEU-EFS_Sebastian KuhnDownload

EORS, 16 – 19, June 2025

HEU-EFS_Marta Kerstan, Alexandra PoulssonDownload

ISPOR 2025, Montréal, 15 May 2025​

HEU-EFS_Giuditta CalleaDownload

ISPOR 2025, May 2025

HEU-EFS Kevin DriskoDownload

MedTechForum 2025, 14 May, 2025

HEU-EFS_MedTech Forum 2025Download

MDCG Clinical Investigation and Evaluation Working Group, 8 April 2025​

HEU-EFS_Giuditta Callea, Alexandra PoulssonDownload

ESC, 20 February, 2025​

HEU-EFS_Maria Luisa Buzelli, Francesco Malandrini​Download

Privileged Talk, Milan, 18 March 2025​

HEU-EFS_Giuditta CalleaDownload

EUPATI Webinar, 28 January 2025

GHH Patient Involvement in MD_EUPATI WebinarDownload

MDCG Clinical Investigation and Evaluation Working Group, 15 November 2024​

HEU-EFS_Giuditta CalleaDownload

Medtech Europe, 24 September 2024​

HEU-EFS_Marta KerstanDownload

​CIE, 22 August, 2024

HEU-EFS_Giuditta Callea, Tom MelvinDownload

MedTech Europe​, 16 July 2024​

HEU-EFS_Helen Banks, Luisa BuzelliDownload

HTAi 2024 Annual Meeting, 17-19 June 2024

HEU-EFS_Adrián ValledorDownload

GERONTE Project Leuven, March 2024

HEU-EFS_Dr. Nicolas MARTELLIDownload

MedTech Europe Cardiovascular Sector Group, 8 March 2024​

HEU-EFS_Giuditta CalleaDownload

MDCG Clinical Investigation and Evaluation Working Group, 4 March 2024​

HEU-EFS_Rosanna Tarricone, Giuditta Callea, Tom MelvinDownload

Info day Horizon Europe European Partnerships, Milano, 26 February 2024​

HEU-EFS_Giuditta CalleaDownload

ISPOR Europe, Copenaghen 14 November 2023

HEU-EFS_Giuditta CalleaDownload

Project Slide Deck, 14 April 2024

HEU-EFS_Project-Slide DeckDownload

CSI Devices for Heart Failure (DHF), 9 December 2023

HEU-EFS Kevin DriskoDownload

Posters

ISPOR Europe 2025 – National Competent Authorities’ Experiences With Early Feasibility Study Assessment: Promoting Dialogue, Supporting Sponsors, and Fostering Shared Learning to Harmonize the EU Framework (11 November 2025)

ISPOREurope_2025_HEU-EFS_Poster_UBDownload

RAPS Euro Convergence 2025 – Are Early Feasibility Studies an orphan approach in the regulatory pipeline for medical devices clinical maturity? (16 May 2025)

Raps Euro Convergence 2025_HEU-EFS_Poster_FCRBDownload

ISPOR US 2025 – Challenges of pre-market clinical investigations of medical devices: a multi-stakeholder perspective presented at (13 May 2025)

ISPOR_2025_HEU-EFS_Poster_UBDownload

ISPOR Europe 2024 – Use of Early Feasibility Studies to Inform Development of Medical Devices presented at (20 November 2024)

ISPOR_2024 HEU-EFS_Poster DBDownload

ISPOR Europe 2024 – Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization across 55 Jurisdictions (17 November 2024)

ISPOREurope24_HEU-EFS_Poster_UBDownload

Wired Health – Harmonized Approach to Early Feasibility Studies for ​Medical Devices in the European Union (HEU-EFS) (13 March 2024)

WiredHealth_HEU-EFS_Poster_UBDownload

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