Webinar on HEU-EFS Pilot Programme

Date: 5 December 2025
Time: 15:00 – 16:00 CET
Location: Online

Join us for an insightful Follow-Up Webinar on the HEU-EFS Pilot Programme, taking place on 5 December 2025 from 15:00 to 16:00 CET.

During this session, we will:

• Dive deeper into the objectives and outcomes of the HEU-EFS Pilot Programme
• Answer your questions live
• Explore opportunities for your involvement in future activities

Whether you’re already engaged or just curious to learn more, this webinar is a great chance to connect, clarify, and collaborate.

Agenda

Missed it or want to revisit the highlights?

You can now watch the full recording below and download the presentations shared during the event:

OPEN CALL FOR PILOTS

The application period is now closed. However, if you are still interested, please feel free to contact pilot@heuefs.eu. We will be happy to continue sharing information aligned with your interests, which may be helpful for future opportunities.

To support interested applicants, a variety of resources are already available, including training videos, templates, and essential To support interested applicants, a variety of resources are already available, including training videos, templates, and essential documents. These materials are designed to help you better understand and navigate the pilot process. You can access them directly through the links provided below.

Access Training videos here.

CIP and Checklist, Informed Consent template and Contract and liability documents available here.

Early Feasibility Studies in European Union

ISO 14155:2020 defines Early Feasibility Studies (EFS) as limited clinical investigations designed to evaluate the initial clinical safety and performance of a medical device.

Conducted at an early stage, before the device design is finalised, EFS help collect critical insights on a device’s design, safety, functionality, and performance, especially when further nonclinical testing is unavailable or not informative.

Why EFS Matter

EFS play a key role in the evidence generation pathway, offering the potential to:

• Increase investment attractiveness in the European medical technology landscape
• Accelerate patient access to safe and innovative medical devices.
• Strengthen the EU’s position as a hub of clinical excellence and innovation.

The Current Challenge

While EFS are permitted under the EU Medical Device Regulation (MDR), there is currently no harmonised pathway or specific framework to support their systematic adoption across the European Union (EU).

The HEU-EFS initiative aims to change this by developing a unified, structured approach to Early Feasibility Studies, enabling innovation and collaboration across Europe.

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.

🔗 Learn more here.

#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

🔗 Read the full article here

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

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:

• Innovative Health Initiative (IHI)
• MedTech Europe
• EFPIA
• COCIR
• EuropaBio
• Vaccines Europe

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

HEU-EFS at the 33rd Annual EORS Meeting

A Showcase of Innovation and Collaboration

We are excited to share the highlights from the 33rd Annual Meeting of the European Orthopaedic Research Society (EORS) in Davos, Switzerland, where the HEU-EFS project was prominently featured.

The event, held from June 16 to 19, 2025, brought together leading experts and stakeholders to discuss critical systems, infrastructure, and policy frameworks needed to drive innovation in orthopaedic research. The HEU-EFS project used this platform to disseminate its latest results and developments through a panel discussion.

Here are some reflections from our esteemed panelists:

• Marta Kerstan, DePuy Synthes: “The symposium was a resounding success! The lectures provided invaluable perspectives from patient organizations, medical devices and digital health technology, surgeons, regulators, scientists, and investors. The interactive panel discussion fostered idea exchanges, making it a remarkable opportunity for learning and collaboration.”
• Yasemin Zeisl, EPF: “Engaging patients throughout the lifecycle of medical devices is essential. It enhances legitimacy, transparency, and accountability in clinical research and innovation, ensuring that real-world experiences shape their development.”
• Susan Partridge, BSI: “This was a great opportunity to present the Notified Body perspective on early feasibility studies at the HEU-EFS symposium in Davos. I thoroughly enjoyed the valuable insights from all panel members.”
• Alexandra Poulsson, NIPH: “The EORS combined conference with ARI Orthopaedics and the International Society for Computer Assisted Orthopaedic Surgery (CAOS) was a great opportunity to showcase the achievements of the HEU-EFS project. It fostered important discussions with researchers, clinicians, patient associations, Notified Bodies, SMEs, and large medical device producers.”
• Ana Matos Machado, TUV Sud: “Harmonizing EFS can significantly enhance the EU market’s attractiveness for innovation”.
• Marta Bragagnolo, GHH: “Involving patients early in the process leads to better outcomes for everyone—patients, clinicians, and innovators alike. Innovation without patient partnership is incomplete. Let’s build healthcare solutions with patients, not just for them.”

We are proud of the impact and visibility the HEU-EFS project has gained through this event and look forward to continuing our efforts to drive innovation in clinical trials.

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 #ClinicalTrials #OrthopaedicResearch

Featured in the photos (l-r): Alexandra Poulsson from the Norwegian Institute of Public Health (podium) and Marta Kerstan from DePuy Synthes, Thomas Randau from Krankenhaus der Augustinerinnen, Marta Bragagnolo from Global Heart Hub, Yasemin Zeisl from European Patients’ Forum, Ana Matos Machado from TÜV SÜD, Sebastian Kuhn from The Philipp University of Marburg, Susan Partridge from BSI, and Roland Herzog from AO Foundation