A week later, we’re reflecting on the insightful discussions and collaborative spirit at the EU Health Technology Assessment Conference: “Advent of a New Era of Collaboration”. We were proud to see the HEU-EFS project represented at this key event, which marked an important step toward a harmonised approach to Early Feasibility Studies (EFS) for medical devices in the EU.
A special thank you to Giuditta Callea (SDA Bocconi) for her valuable contributions during the panel discussion, helping to shape the conversation around innovation in health technology assessment.
With pilot cases set to launch in 2026, momentum is building!
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
#HTA #MedicalDevices #EarlyFeasibilityStudies #ClinicalResearch
Issue #2 June 2025
Issue #1 November 2024
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
We are excited to announce that Associate Professor Tom Melvin from the University of Galway, and a member of the HEU-EFS consortium, presented our project at the #FutureTrials25 event.
Event Overview: Organised by the University of Galway – Institute for Clinical Trials in partnership with Medtronic, a member of the HEU-EFS public-private consortium, this event brought together leading experts and stakeholders to discuss the critical systems, infrastructure, and policy frameworks needed to drive innovation in clinical trials. The audience included researchers, policymakers, healthcare professionals, and industry leaders.
HEU-EFS Presence:
About HEU-EFS: The HEU-EFS project aims to develop a harmonised framework for conducting Early Feasibility Studies (EFS) for medical devices in the EU. By enhancing the uptake of EFS, we strive to boost the EU’s competitiveness and ensure that patients have access to innovative, safe, and effective medical technologies.
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
#ClinicalTrials #EvidenceGeneration #PatientCare #IHITransformingHealth #MedTech
HEU-EFS attending European Orthopaedic Research Society Annual Meeting
We are pleased to announce that the HEU-EFS project will be showcased at the 33rd Annual Meeting of the European Orthopaedic Research Society Annual Meeting, taking place from June 16 to 19, 2025, in Davos, Switzerland. The Summit aims to promote research and development in orthopaedic surgery, as well as related sciences, through interdisciplinary coordination, exchange of scientific and technical experience, and education. The event will take place at the Conference Center Davos, a renowned venue for the World Economic Forum.
The HEU-EFS project will use #EORS2025 as a platform to disseminate its latest results and developments.
The session will begin with an introduction to the HEU-EFS Project by Alexandra Poulsson from the Norwegian Institute of Public Health and Marta Kerstan from DePuy Synthes, followed by a keynote address from Chief Medical Officer Thomas Randau. A series of short expert presentations will be delivered by Marta Bragagnolo from Global Heart Hub, Yasemin Zeisl from European Patients’ Forum, Ana Matos Machado (Neurosurgeon and Advisory Board Member of HEU-EFS), Sebastian Kuhn from The Philipp University of Marburg, Susan Partridge from BSI, and Roland Herzog from AO Foundation, culminating in a panel discussion featuring all speakers.
You are welcome to join us on Tuesday, 17 June, 11:15-12:40 (Room Sertig), to learn how HEU-EFS is driving innovation and improving clinical outcomes in orthopaedic research. Don’t miss this chance to connect with leading professionals and explore groundbreaking developments in the field.
Stay tuned for more updates and follow our journey at heuefs.eu.
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
#IHITransformingHealth #EvidenceGeneration #MedTech
Date: 15/05
Time: 13:45 – 14:45 (PDT)
Location: Montreal, QC, Canada
Session Type: Concurrent Breakout Session
Join us for an engaging session on Bridging the Gap in Early Stage Clinical Research: Lessons for EU Stakeholders From the US FDA Early Feasibility Studies Program. This event will explore the challenges and opportunities in early-stage clinical investigations for medical devices (MDs) and what the EU can learn from the US FDA’s Early Feasibility Studies (EFS) Program.
This session is highly beneficial for regulators, healthcare providers, patient associations, academic and research organizations, CROs, ethical and legal experts, and technology developers. Don’t miss this opportunity to gain valuable insights and engage with experts in the field. Register here!
Date: 14/05
Time: 14:10 – 15:00 (GMT+1)
Location: Lisbon, Portugal
Session Type: Parallel session
Join us for an insightful session on Empowering European Innovators With Early Feasibility Studies (EFS). This event is part of the HEU-EFS project, an initiative by the Innovative Health Initiative (IHI) aimed at developing a harmonized EU framework to enhance the uptake of EFS for medical devices across Europe. EFS are vital in the evidence-generation cycle for medical devices, and conducting these studies in a coordinated manner will bring significant benefits to patients, innovators, and the entire healthcare system.
Don’t miss this opportunity to learn from leading experts and engage in discussions that will shape the future of medical device innovation in Europe. Register here!
The HEU-EFS consortium was proud to be represented at the European Society of Cardiology Cardiovascular Round Table (CRT) meeting with the European Medicines Agency (EMA) in Amsterdam. This high-level event brought together leading voices from cardiology, regulatory bodies, industry, and patient communities to explore how Patient Experience Data (PED) and Patient Reported Outcomes (PROs) can shape the future of cardiovascular care.
Notably, Maria Luisa Buzelli (SDA Bocconi) and Prof. Piotr Szymański, Advisory Board member of HEU-EFS and Chair of the ESC Regulatory Affairs Committee (2024–2026), contributed to the discussions, reinforcing the consortium’s commitment to regulatory innovation and patient-centered research.
The roundtable featured open and constructive dialogue on the role of PED and PROs in clinical trials and regulatory decision-making. Highlights included:
As Prof. Szymański noted, “This is a pivotal moment for aligning regulatory science with what truly matters to patients.”
The HEU-EFS project is deeply aligned with these goals. By integrating patient perspectives into the design and evaluation of future cardiovascular therapies, HEU-EFS aims to ensure that innovation translates into meaningful patient benefit. The CRT meeting served as a powerful platform to showcase this vision and to engage with key stakeholders shaping the future of cardiovascular regulation.
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
#ESCardioCRT #HealthcareInnovation #PatientAccess #MedTech #EvidenceGeneration #ClinicalTrials
[7-8 October 2024, Geneva] – The HEU-EFS Consortium gathered for our annual consortium meeting, marking a significant milestone in our journey towards harmonizing Early Feasibility Studies (EFS) across Europe.
The collaboration and expertise of our consortium members were on full display as we worked together to address the challenges and opportunities within the EFS ecosystem. We are excited to share that our collective efforts are paving the way for a more efficient and effective European Health System.
Introduction
Sponsors of pre-market clinical investigations for medical devices are invited to participate in an online survey conducted as part of the Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) project (Grant Agreement no. 101112185).
Funded by the Innovative Health Initiative (IHI), HEU-EFS aims to develop a robust, standardized methodology and set recommendations to streamline Early Feasibility Studies (EFS) within the EU.
Establishing a clear, harmonized framework for EFS in the EU is expected to benefit patient access, innovation uptake and investment attractiveness in Europe.
Survey
This survey focuses on pilot pre-market clinical investigations (CI) to assess a medical device early in its development phase. These include first-in-human, early feasibility, and traditional feasibility clinical investigations. When answering, please consider specifically the challenges of planning, monitoring and conducting CI in Europe.
Take the survey https://bit.ly/HEU-EFS_Survey
The survey will be open until 11 November.
The results will be presented in a dedicated webinar and on the HEU-EFS project webpage.