HEU-EFS to Join the IHI Forum 2026 in Brussels
The HEU-EFS consortium will participate in the IHI Forum 2026: Translating Research into Long-Term Impact, taking place on 20-21 October 2026 in Brussels, Belgium. The Forum brings together representatives from research, industry, healthcare, patient organisations, regulatory bodies, and public institutions to discuss how collaborative research can deliver meaningful and lasting impact for European healthcare.
The two-day programme focuses on the role of public-private partnerships in advancing healthcare innovation and addressing challenges across the research and innovation ecosystem. Discussions will explore how collaboration can accelerate the development and adoption of new therapies, medical technologies, diagnostics, artificial intelligence solutions, and patient-centred healthcare approaches.
On the first day, participants will hear from leaders representing the European Commission, industry, and health innovation organisations during a high-level panel discussion on the importance of public-private partnerships in translating research into long-term impact. The afternoon workshops will examine topics spanning the full continuum of care, including emerging therapeutic and diagnostic technologies, medical devices, AI applications, and strategies for preparing healthcare systems to adopt innovative solutions.
A dedicated poster session and networking programme will also provide opportunities for researchers and stakeholders to exchange ideas, build new collaborations, and showcase ongoing innovation projects.
The second day will focus on the importance of multi-stakeholder alignment in healthcare innovation, highlighting perspectives from patient organisations, regulators, academia, and industry. Workshops will explore patient co-creation in research partnerships and discuss how Europe can overcome barriers across the innovation journey, including regulatory, health technology assessment (HTA), and market access challenges.
Many of the themes featured throughout the Forum closely align with the objectives of HEU-EFS. By supporting the development of a harmonised European approach to Early Feasibility Studies for medical devices, the project contributes to discussions around innovation pathways, stakeholder collaboration, patient involvement, regulatory readiness, and the translation of research into tangible benefits for patients and healthcare systems.
HEU-EFS looks forward to joining the IHI community in Brussels and contributing to conversations that will help shape the future of healthcare innovation in Europe.
Event Information
Event: IHI Forum 2026 – Translating Research into Long-Term Impact
Date: 20-21 October 2026
Location: Brussels, Belgium
Venue: The Egg, Rue Bara 175, 1070 Brussels
What Happens When Evidence Starts Earlier? HEU-EFS to Be Discussed at Upcoming HTAi Webinar
For innovative medical devices, generating evidence early can play an important role in guiding development, understanding initial clinical safety and performance, and supporting better-informed decisions throughout the device lifecycle. Yet across Europe, approaches to Early Feasibility Studies (EFS) remain fragmented, highlighting the need for greater coordination and harmonisation.
On 16 September 2026, the HTAi Medical Devices Interest Group (MDIG) will host a webinar exploring the role of EFS in early evidence generation and their potential implications for Health Technology Assessment (HTA).
Early evidence, better-informed decisions
The webinar, “Early Feasibility Studies for Medical Devices: HEU-EFS Progress and Implications for Early Evidence Generation and HTA,” will provide an opportunity to discuss the latest developments of the HEU-EFS project and consider how EFS can contribute to evidence generation for innovative medical devices.
EFS are limited clinical investigations conducted at an early stage of device development. They can generate important insights into a device’s initial clinical safety and performance and help inform subsequent development and design modifications.
For the HEU-EFS project, strengthening this early stage of the evidence-generation pathway is central to the development of a harmonised EU methodology for EFS. The project brings together 22 public and private partners to develop, test and validate a methodology that can support the uptake of EFS across Europe.
The webinar will explore what earlier evidence generation could mean for HTA, innovation and decision-making, as well as the opportunities and challenges associated with integrating EFS into European innovation and assessment pathways.
Meet the speakers
The session will feature:
- Laura Sampietro-Colom, Hospital Clínic de Barcelona
- Giuditta Callea, SDA Bocconi
- Andrea Rappagliosi, Edwards Lifesciences
- Adrián Valledor Sánchez, IDIBAPS
The discussion will be moderated by Richard Charter, Co-Chair of the HTAi Medical Devices Interest Group. Sasha Poulsson, WP3 Leader, will also contribute to the discussion.
📅 16 September 2026
🕒 3:00–4:00 PM GMT
Join the discussion and learn more about how the HEU-EFS project is working towards a more harmonised approach to Early Feasibility Studies in Europe.
Learn more: https://htai.org/resource/htai-webinar/
HEU-EFS Submits Second Position Paper on the Revision of the EU Medical Device Regulation
The HEU-EFS project has submitted its second set of recommendations on the proposed targeted revision of the European Union Medical Device Regulation (EU MDR), following the publication of the European Commission’s revision proposal in December 2025.
Building on its previous submission, the consortium welcomes several positive developments in the proposed revision, including greater emphasis on dialogue with regulators and improvements in the management of clinical investigations throughout the medical device lifecycle. At the same time, HEU-EFS highlights several areas where additional clarification and targeted measures could further strengthen Europe’s ability to support innovative medical technologies and early clinical research.
Supporting Early Feasibility Studies in Europe
A key recommendation from the consortium is the explicit recognition of Early Feasibility Studies (EFS) within the MDR framework.
EFS play a crucial role in the development of innovative medical devices by generating early clinical evidence and enabling iterative improvements before final device design is finalised. While the revised proposal acknowledges various types of exploratory investigations, EFS are not specifically referenced.
The HEU-EFS consortium recommends formally recognising EFS, including their different development stages, and aligning terminology with internationally recognised standards such as ISO 14155:2020. Such recognition would help create a clearer clinical development pathway, improve consistency across Member States, and support future initiatives aimed at making Europe a more attractive location for early-stage clinical research.
Strengthening Early Dialogue with Regulators
The proposed MDR revision introduces new provisions encouraging dialogue between manufacturers and notified bodies, an important step towards greater regulatory predictability.
However, HEU-EFS believes similar opportunities should be available between manufacturers and National Competent Authorities (NCAs) during the planning and conduct of clinical investigations. Early scientific and regulatory discussions can help sponsors design appropriate evidence-generation strategies, particularly for highly innovative and high-risk medical devices.
The consortium therefore recommends introducing structured and voluntary dialogue mechanisms throughout the clinical investigation process, helping developers navigate regulatory requirements more efficiently while maintaining high standards of patient protection.
A More Proportionate Approach for Early-Stage Research
Another area highlighted by HEU-EFS relates to the timing of non-clinical testing requirements.
Early-stage investigations often seek to answer fundamental questions about device performance and design. In some cases, not all non-clinical testing can reasonably be completed before clinical studies begin. The consortium proposes a more risk-based approach that would ensure participant safety while allowing certain non-critical tests to be completed later in the development process when scientifically justified.
This approach could help facilitate iterative innovation without compromising safety.
Enabling Design Improvements During Clinical Investigations
Medical device development is frequently an iterative process. Insights gained during early clinical investigations may lead to design improvements that enhance safety, usability, or performance.
HEU-EFS therefore calls for clearer guidance on how design modifications should be managed during early-stage clinical investigations. Greater clarity would help sponsors understand when modifications require amendments and when a complete resubmission is necessary, reducing unnecessary administrative burden while preserving regulatory oversight.
Towards a Dedicated EFS Pathway
The consortium also highlights the need for a dedicated and more predictable review process for Early Feasibility Studies across Europe.
Current implementation can vary significantly between Member States, creating uncertainty for innovators. HEU-EFS recommends exploring a dedicated submission and review pathway, supported by clear timelines, templates, and guidance, to improve efficiency and encourage investment in clinical research within Europe.
Driving Innovation While Protecting Patients
Through these recommendations, the HEU-EFS project aims to contribute to a regulatory framework that supports innovation while maintaining the highest levels of patient safety.
By recognising Early Feasibility Studies, encouraging early dialogue between developers and regulators, and enabling more flexible and proportionate clinical development pathways, Europe can strengthen its position as a global leader in medical device innovation and bring promising technologies to patients more efficiently.
HEU-EFS Annual Meeting 2026: Advancing Early Feasibility Studies in Europe
From 5–7 July 2026, the HEU-EFS consortium gathered in Oslo, Norway, for its Annual Meeting, hosted by the Norwegian Institute of Public Health (NIPH) and the Norwegian Medical Products Agency (NoMA). The event brought together consortium partners, regulators, industry representatives, patient organisations, healthcare professionals, and members of the Advisory Board to review project progress and discuss the future of Early Feasibility Studies (EFS) in Europe.
The meeting began with internal and satellite sessions on adapting the HEU-EFS framework to Digital Health Technologies (DHTs) and exploring incentives for research and development in the European Union. These were followed by two days of presentations, panel discussions, and interactive sessions covering project achievements, pilot activities, regulatory developments, dissemination, and the evolving European medical device landscape.
A key focus of the programme was the implementation of the HEU-EFS framework through pilot activities, with stakeholders sharing experiences and discussing opportunities to improve evidence generation for innovative medical devices. Dedicated sessions also explored the adaptation of the framework for Digital Health Technologies and recent developments related to the Medical Device Regulation (MDR).
The meeting also featured a Young Scientists Session, where PhD researchers presented their work on topics including clinical investigations, digital medical devices, regulatory frameworks, and market access, highlighting the important contribution of early-career researchers to the project.
The Annual Meeting concluded with discussions on the consortium’s next milestones and future activities. HEU-EFS thanks all speakers, participants, and organisers for their valuable contributions and continued commitment to advancing innovation in medical device research across Europe.
HEU-EFS at ISPOR US 2026: Advancing Dialogue on Harmonized EFS Frameworks
HEU-EFS was proud to participate in ISPOR US 2026, joining global leaders in health economics, outcomes research, and healthcare policy to discuss the future of evidence generation and healthcare decision-making.
The conference provided an excellent opportunity to disseminate the work of the HEU-EFS project to an international audience. Through our presentations and discussions, we highlighted the importance of predictable timelines and early interactions between sponsors and health authorities in establishing a harmonized Early Feasibility Study (EFS) framework across Europe.
As Federico Facciolo noted, sharing our work within such a global forum reinforced how these policy approaches can support innovation not only within the EU MedTech ecosystem but also across healthcare systems worldwide. The event enabled us to position the HEU-EFS framework within the broader health economics and policy landscape, fostering valuable conversations with industry leaders, academic experts, government representatives, and other key stakeholders.
We thank everyone who engaged with us throughout the conference and look forward to continuing these important discussions to advance patient-centered innovation, improve access to medical technologies, and support better outcomes for patients.
HEU‑EFS at HTAi 2026: Advancing Patient‑Centred Innovation
From 06–10 June 2026, the global Health Technology Assessment (HTA) community will gather in Istanbul for HTAi 2026, an important moment to reflect on how innovation is evaluated and brought into healthcare systems.
At this year’s conference, HEU‑EFS will contribute to the discussion by focusing on one key question: how can Early Feasibility Studies (EFS) better serve patients across Europe?
Early Feasibility Studies are a crucial step in the development of innovative medical devices. Yet across Europe, approaches to EFS remain fragmented, making it harder to generate consistent evidence and ensure timely access to new technologies. The work presented by HEU‑EFS, in collaboration with the European Patients’ Forum (EPF) and Global Heart Hub, explores how a more harmonised and patient‑centred approach can help address this challenge.
A central element of this work is the active involvement of patients themselves. Through a dedicated Patient Advisory Group, individuals and caregivers across different disease areas have contributed their perspectives on how EFS are designed, communicated, and experienced.
Their input highlights a clear need for:
- more accessible and transparent information
- stronger communication throughout studies
- and greater support for participants
By bringing these insights together, the initiative proposes a more structured and inclusive approach to EFS, one that not only strengthens evidence generation but also ensures that innovation better reflects real patient needs.
Ultimately, this work goes beyond individual studies. It contributes to a broader shift towards more trustworthy, inclusive, and effective healthcare innovation in Europe, where patients are not just participants, but active partners in shaping the future of medical technologies.
Stay tuned for updates from HTAi 2026 and follow how HEU‑EFS is helping drive a more patient‑centred approach to innovation.
HEU-EFS at ISPOR 2026
HEU-EFS is proud to announce our participation in ISPOR 2026.
The Professional Society for Health Economics and Outcomes Research, where global leaders across health economics, outcomes research, and healthcare policy come together to shape the future of evidence generation and healthcare decision-making.
As innovation continues to transform healthcare systems worldwide, ISPOR provides a unique platform for collaboration, knowledge exchange, and discussions on advancing patient-centered, data-driven solutions.
During the event, HEU-EFS will engage with international experts, researchers, policymakers, and industry stakeholders to explore how innovation, evidence generation, and collaboration can strengthen the EU MedTech ecosystem and support better outcomes for patients.
We look forward to contributing to meaningful conversations on the future of healthcare evaluation, access, and sustainable innovation.
HEU-EFS Launches Task 3.1.6 on Support and Reimbursement Conditions for Investigational Medical Devices
The HEU-EFS consortium has officially launched Task 3.1.6, bringing partners together to map support and reimbursement conditions for investigational medical devices across Europe.
This important activity represents a key step toward enabling more effective Early Feasibility Studies (EFS), supporting the uptake of medical innovation, and contributing to the enhancement of Europe’s competitiveness in the medtech sector.
Collaborative Leadership Across the Consortium
The task is jointly led by SDA Bocconi and Greater Paris University Hospitals – AP-HP, with contributions from partners across the HEU-EFS consortium.
By pooling expertise, knowledge, and resources from across the partnership, the consortium aims to build a comprehensive understanding of the current landscape and identify practical approaches to support innovation and patient access.
As the work progresses, HEU-EFS will continue sharing updates and insights from this important initiative.
Stay tuned for more developments in the coming months.
HEU-EFS Mid-Term Virtual Consortium Meeting Marks Key Milestone in Year 3
On 16 April 2026, the HEU-EFS consortium gathered online for its Mid-Term Virtual Consortium Meeting, bringing together project partners to reflect on progress achieved so far and align on priorities for the next phase of the project.
The meeting marked an important milestone in Year 3 of HEU-EFS and provided a valuable platform for collaboration, strategic discussion, and knowledge exchange across the consortium.
Reviewing Progress and Shaping the Next Phase
Throughout the meeting, partners reviewed achievements across multiple Work Packages (WP2–WP9), highlighting the progress made toward advancing a harmonised European framework for Early Feasibility Studies (EFS) in medical devices.
Key discussions focused on:
- Project progress and overall impact achieved to date
- Developments in the evolving EU regulatory landscape
- Newly established Task Forces related to MDR revision, Digital Health Technologies, and R&D incentives
- Pilot use cases and engagement with National Competent Authorities
- Dissemination activities, project management updates, and upcoming milestones
The consortium also discussed future priorities and preparations for upcoming meetings, including the Annual Consortium Meeting scheduled to take place in Oslo in July 2026.
Strengthening Collaboration Across Europe
The meeting demonstrated the continued strength of collaboration across the HEU-EFS consortium, with partners contributing expertise from regulatory, clinical, academic, industry, and public health perspectives.
We would like to sincerely thank all consortium partners for their valuable contributions, active engagement, and continued commitment to the project’s objectives.
HEU-EFS at The MedTech Forum 2026: Advancing Early Feasibility Studies in Europe
rom 11–13 May 2026, the HEU-EFS project joined leading innovators, policymakers, researchers, patient representatives, and industry stakeholders at The MedTech Forum 2026 in Stockholm to discuss the future of medical technology in Europe.
As part of the event, HEU-EFS hosted a panel discussion titled:
“Accelerating Early Feasibility Studies for Medical Devices in Europe”
Moderated by Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), the session brought together a diverse group of experts representing patient advocacy, academia, regulatory affairs, public health, and industry.
Panel Speakers
- Marta Bragagnolo
- Maria Luisa Buzelli
- Karin Fricke
- Tom Melvin
- Alexandra Poulsson
The discussion explored how a harmonised European framework for Early Feasibility Studies (EFS) could help accelerate innovation while improving patient access to breakthrough medical technologies.
Panelists shared insights on the importance of collaboration between public and private stakeholders through the Innovative Health Initiative (IHI), highlighting how coordinated efforts can strengthen Europe’s position as a global hub for medical device research and development.
Key themes included:
- Improving pathways for early-stage clinical investigation in Europe
- Enhancing collaboration across regulators, industry, academia, and patient organisations
- Creating a more predictable and efficient EFS environment
- Supporting faster access to innovative technologies for patients
- Strengthening Europe’s competitiveness in medtech innovation
The session reinforced the shared commitment across the European medtech ecosystem to build a more harmonised and innovation-friendly environment for Early Feasibility Studies.
HEU-EFS, supported by the Innovative Health Initiative (IHI), continues to work toward making this vision a reality by fostering collaboration and contributing to the development of a more effective EU EFS framework.
We thank everyone who joined the discussion in Stockholm and look forward to continuing the conversation on the future of MedTech innovation in Europe.
bout HEU-EFS
The HEU-EFS project aims to advance the development of a harmonised European framework for Early Feasibility Studies in medical devices, supporting innovation while ensuring patient safety and regulatory excellence.