Implementing a Program for EarlyFeasibility Studies in Europe:Goldmine or Fool’s Gold? (ISPOR Europe, November 2025)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union (Clinical Investigations WG MD, 26 November 2025)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union (MDCG CIEPSE Working Group, 13 November 2025)
How to win and manage a Horizon project– the case of HEU-EFS (RIS4SEB Consortium meeting, Milan, 9 September 2025)
Harmonised approach to EFS in the EU – Meeting with DGSANTE (Meeting with DGSANTE, 3 July, 2025)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union - EU Health Technology Assessment: Advent of a new era of collaboration (HTA Conference, 2 July 2025)
Marta Kerstan (DePuy Synthes) and Alexandra Poulsson (NIPH) Presentation on European Orthopaedic Research Society Annual meeting (EORS, 17 June 2025)
Challenges of pre-market clinical investigations of medical devices: a multi-stakeholder perspective – Issue Panel Bridging the Gap in Early-Stage Clinical Research: Lessons for EU Stakeholders from the US FDA Early Feasibility Studies Program (ISPOR 2025, Montréal, 15 May 2025)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union (MDCG Clinical Investigation and Evaluation Working Group, 8 April 2025)
The role of patients in the early feasibilitystudies of medical devices, PEDs and PROs – Engaging patients in the development of an Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (ESC, 20 February, 2025)
US vs. EU: 10 Years of Experience with EFS vs. a Program Starting to Emerge in Europe (Privileged Talk, Milan, 18 March 2025)
Marta Bragagnolo (GHH) on Patient Involvement Webinar in Early Feasibility Studies (EUPATI Webinar, 28 January 2025)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union – Progress and preliminary results (MDCG Clinical Investigation and Evaluation Working Group, 15 November 2024)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union (Medtech Europe, 24 September 2024)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union – Engagement of National Competent Authorities (CIE, 22 August, 2024)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union – Overview (MedTech Europe, 16 July 2024)
Health Technology Assessment: Methods, Tools, and Specific Criteria Applicable to Innovative Medical Devices (GERONTE Project Leuven March 2024)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union (MedTech Europe Cardiovascular Sector Group, 8 March 2024)
HEU-EFS Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union (MDCG Clinical Investigation and Evaluation Working Group, 4 March 2024)
HEU-EFS – Harmonised approach to Early Feasibility Studies for Medical Devices in the European Union (Info day Horizon Europe European Partnerships, 26 February 2024, Milano)
Setting up a harmonized methodology to promote uptake of early feasibility studies for clinical and innovation excellence in the European union: What value(s)? Presentation at ISPOR Europe (14 November, 2023, Copenaghen)
Project Slide Deck (14 April 2024)
National Competent Authorities’ Experiences With Early Feasibility Study Assessment: Promoting Dialogue, Supporting Sponsors, and Fostering Shared Learning to Harmonize the EU Framework presented at Ispor Europe 2025 (11 November 2025)
Are Early Feasibility Studies an orphan approach in the regulatory pipeline for medical devices clinical maturity? by Adrián Valledor presented at RAPS Euro Convergence 2025 (16 May 2025)
Challenges of pre-market clinical investigations of medical devices: a multi-stakeholder perspective presented at Ispor US 2025 (13 May 2025)
Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization across 55 Jurisdictions by Francesco Malandrini presented at Ispor Europe 2024 (17 November 2024)
Harmonized Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) by Prof. Giuditta Callea, PhD presented at Cardiocare (14 June 2024)
Harmonized Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) presented by Prof. Giuditta Callea, PhD at Wired Health (13 March 2024)