Why Early Feasibility Studies Matter for EU Innovation
The European Commission’s recent Call for Evidence on the future of the MDR and IVDR was more than just another regulatory step, it was a real chance to shape how innovation happens in Europe.
For projects like HEU-EFS, this moment really matters.
Early Feasibility Studies (EFS) are small, early-stage clinical investigations that help researchers and developers explore a device’s safety and performance before large-scale trials. They’re crucial when lab testing alone isn’t enough, think high-risk devices, breakthrough technologies, or solutions tackling unmet medical needs.
But there’s a problem: while EFS aren’t excluded under current EU rules, there’s no clear, harmonised pathway to support them. That gap creates uncertainty, slows progress, and makes Europe a tougher place for MedTech innovators to start.
That’s why the HEU-EFS project, funded under the Innovative Health Initiative (IHI), submitted focused recommendations to the European Commission, calling for:
- A clear EU definition of EFS aligned with international standards
- Early dialogue between sponsors, regulators, ethics committees, and expert panels
- Flexibility to run some nonclinical testing in parallel with EFS
- Dedicated templates and tools to simplify EFS applications and reviews
These steps wouldn’t just help researchers, they would speed up patient access to new treatments, lower development risks, and boost Europe’s global standing in medical technology.
The Call for Evidence may have closed on 6 October, but the conversation isn’t over. Let’s keep pushing to make EFS a recognized and supported part of the EU regulatory framework.
#EFS #MedicalDevices #MDR #IVDR #Innovation #HealthTech #EURegulations #HEUEFS #AMIRES #PublicConsultation #ClinicalResearch #MedTechEurope #IHI #HorizonEurope
HEU-EFS Project Featured in JMIR
We’re pleased to share that the HEU-EFS Project has been featured in JMIR, a leading journal in digital health research.
Article Title:
Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union
The article highlights the crucial role of Early Feasibility Studies (EFS) in advancing digital health technologies, including AI-enabled medical devices. It also underlines the importance of a harmonized EU framework to foster innovation while maintaining safety and performance standards.
Key Highlights:
- EFS enable early testing and user feedback, helping innovators refine technologies before full-scale clinical trials.
- EU regulations must evolve to better accommodate the unique needs of digital health technologies.
- The HEU-EFS Project is actively working to improve EFS uptake and streamline pathways for innovators across Europe.
HEUEFS #EarlyFeasibilityStudies #DigitalHealth #MedicalDevices #EUInnovation #JMIR #HealthTech #EUProjects #PublicPrivatePartnership
World Heart Day 2025: Don’t Miss a Beat
Cardiovascular disease remains the leading cause of death globally. Yet, many of these lives could be saved through earlier access to innovative and effective care.
On September 29, we mark World Heart Day by joining the global movement to raise awareness and advocate for heart health.
This year’s theme, #DontMissABeat, reminds us that every heartbeat matters, and that timely innovation can make all the difference.
At HEU-EFS, we are committed to improving access to life-saving technologies for patients with unmet medical needs. Our work focuses on creating a harmonised EU framework for Early Feasibility Studies (EFS), a critical step in accelerating the development of innovative medical devices.
Through a public-private partnership of 22 institutions, funded by the European Commission, HEU-EFS is aligning regulatory, clinical, and innovation stakeholders to streamline the EFS process across Europe.
Because when it comes to heart health, every moment, and every heartbeat, counts.
Learn more about our mission and progress on our LinkedIn.
Public Forum on Early Feasibility Studies
Date: 11/04
Time: 15:30 to 17:30 CET
Location: Online
Join us online for the HEU-EFS Public Forum, a key opportunity to explore how Early Feasibility Studies (EFS) can accelerate access to innovative medical technologies in Europe.
This virtual event will bring together regulators, industry leaders, clinicians, and patient representatives to discuss a harmonised EU approach to EFS. The forum aims to highlight the importance of EFS in improving patient access and supporting clinical excellence.
Agenda
| Time | Theme | Speaker |
| 15.30 – 15.35 | Welcome, Objectives & introduction | Tom Melvin, Andrea Rappagliosi, Edwards Lifesciences Giuditta Callea |
| 15.35 – 15.45 | Strategic vision for the future of European EFS | Giuditta Callea, Bocconi University |
| 15.45 – 16.20 | From where we start: the current state of play of EFS in Europe | Federico Facciolo, Bocconi University Marta Kerstan, Johnson & Johnson Nicolas Martelli, Assistance Publique – Hôpitaux de Paris |
| 16.20 – 16.55 | Where to Go: developing a new methodology for HEU-EFS in Europe | Alexandra Herborg Cornelius Poulsson, Norwegian Institute of Public Health Yasemin Zeisl, European Patients Forum |
| 16.55 – 17.15 | Testing the HEU-EFS Methodology and the opportunity for innovators: launch of pilots | Manon Gielkens, MEDTRONIC Fanny van der Loo, Edwards Lifesciences Giuditta Callea, Bocconi University |
| 17.15 – 17.30 | Interactive Q&A, Next steps and closing | Tom Melvin, University of Galway Giuditta Callea, Bocconi University Andrea Rappagliosi, Edwards Lifesciences |
Missed it or want to revisit the highlights?
You can now watch the full recording below and download the presentations shared during the event:
Annual Consortium Meeting 2025
Medical Innovation in Barcelona
[15-16 September 2025, Barcelona] This year, the HEU-EFS Consortium gathered in Barcelona for its Annual Meeting, hosted by the Hospital Clínic de Barcelona. This special event coincided with World Patient Safety Day, highlighting our collective commitment to putting patients at the heart of medical advancements.
The meeting brought together an inspiring group of experts, researchers, industry leaders, and patient representatives, all focused on advancing the development of Early Feasibility Studies (EFS) for medical devices across Europe. It was an opportunity to reflect on the progress we’ve made and set the stage for the next steps in medical innovation.
Key Highlights from the Agenda:
- Improving Early Clinical Evidence Pathways
A crucial discussion around harmonizing regulatory practices across the EU to streamline clinical pathways and improve early clinical evidence. - Evidence & Data Tools
Presenting new frameworks designed to enhance clinical investigation planning and strengthen statistical validation tools that will shape future clinical trials. - Patient Engagement
Strengthening partnerships with patient organizations to ensure that patient voices remain central to the development of new technologies and treatments. - Ethics & Legal Foundations
Addressing the complexities of informed consent, trial agreements, and insurance protocols to ensure that every study is ethical and compliant. - Monitoring & Piloting
Establishing performance metrics and criteria for pilot studies that reflect real-world clinical needs, ensuring that future trials meet actual patient care challenges.
A Special Guest Contribution:
We were privileged to welcome Flora Giorgio from the European Commission (DG SANTE), who shared valuable insights into how EU policy is fostering safer, more inclusive innovation in the medical tech sector.
Thank You to Our Partners:
A big thank you to all our 𝗽𝗮𝗿𝘁𝗻𝗲𝗿𝘀 for your ongoing dedication to innovation, safety, and putting patients first:
- SDA Bocconi
- Fundació Clínic per a la Recerca Biomèdica
- IDIBAPS
- Hospital Clínic de Barcelona
- Agenas
- Greater Paris University Hospitals – AP-HP
- Idris Oncology BV
- Meditrial
- Norwegian Institute of Public Health
- Trinity College Dublin
- University of Galway – Institute for Clinical Trials
- The Philipp University of Marburg
- CIMT
- Carmat
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- European Patients’ Forum
- Newronika S.p.A.
- Global Heart Hub
- Qurasoft
- Edwards Lifesciences
- Medtronic
- W. L. Gore & Associates
- Philips
- Abbott
- DePuy Synthes
- Johnson & Johnson
Supported By:
Together, we’re driving meaningful change in medical technology, always with the goal of making healthcare safer and more accessible for patients everywhere. Thank you to everyone who attended and contributed to making this year’s meeting a success.
Stay informed and inspired!
Follow us on LinkedIn to see how we’re driving change in medical innovation with the HEU-EFS Consortium.
HEU-EFS Annual Consortium M24 Meeting
15-16 September 2025
Venue: Carrer de la Diputació, 231, L’Eixample, 08007 Barcelona, Spain
Agenda
HEU-EFS at the EU HTA Conference
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
Other Materials
Newsletters
Issue #2 June 2025
Issue #1 November 2024
Project featured in Journals
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
Background Publications
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.
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.
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.
Videos
Introducing HEU-EFS
Andrea Rappagliosi (Edwards Lifesciences Europe)
Rosanna Tarricone (SDA Bocconi)
HEU-EFS Annual Consortium Meeting in Geneva
Andrea Rappagliosi (Edwards Lifesciences Europe)
Rosanna Tarricone (SDA Bocconi)
Annette Brüls (Edwards Lifesciences Europe)
International Women’s Day
Advancing Gender Equality in Healthcare: Insights from Leading Experts
Dr. Laura Sampietro-Colom (Hospital Clínic de Barcelona)
Cinzia Santin (W. L. Gore & Associates)
Patient Advisory Group
Massimo Russo – Italy: Cardiovascular patient
Tamool M. – Egypt: Type 1 Diabetes patient
Christian Pfeuffer – Germany: Spinal Muscular Atrophy Patient
Patient Associations
Yasemin Zeisl (European Patients’ Forum)
Marta Bragagnolo (Global Heart Hub)
World Telecommunication and Information Society Day
Advancing Early Evidence for Health Technology Innovations
Sebastian Kuhn (Philipp University of Marburg)
Early Feasibility Studies at the MedTech Forum 2025
Niklas Blomberg (Innovative Health Initiative – IHI), Rosanna Tarricone (SDA Bocconi), Alexandra Poulsson (Norwegian Institute of Public Health), Yasemin Zeisl (European Patients’ Forum), Fanny van der Loo (Edwards Lifesciences Europe), Laura Sampietro-Colom (Hospital Clínic de Barcelona).
FutureTrials25
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:
- In the session titled “Fostering an Enabling Landscape,” Prof. Tom Melvin shared valuable insights on the “EU Harmonised Approach to Early Feasibility Studies.” This session highlighted the importance of regulation, collaboration, and infrastructure in creating a thriving clinical trials environment.
- The session also featured a panel discussion with our advisory board member, Dr Donal O’Connor, representing the Health Products Regulatory Authority (HPRA). The discussion emphasised the need for greater harmonisation and stronger connections between policy and practice.
- In the third and final session, “Future Innovation/Emerging Technologies” Despina Voulgaraki, Senior Director for Clinical Research and Medical Science at Medtronic, delivered a keynote on the technologies and trends shaping the future of clinical trials, including artificial intelligence, decentralised models, and personalised approaches.
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 @ EORS 2025
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