CSMD-Horizon Conference 2025: Shaping the Future of AI and Digital Health in MedTech
On 4–5 November 2025, Brussels became a hub for innovation in healthcare technology during the CSMD-Horizon Special Conference for MedTech AI and Digital Health: Regulation, Market Access and Clinical Evidence.
This year’s event marked the merger of two leading forums, the Conference on Clinical Studies with Medical Devices (CSMD) and the Horizon Conference on Clinical Investigations and Market Access, creating a unified platform to explore both the opportunities and challenges surrounding AI-enabled medical devices and digital health technologies.
The conference brought together regulatory experts, clinical leaders, R&D professionals, and MedTech innovators to discuss how AI and software are reshaping clinical studies, regulatory frameworks, and patient care.
Key Themes
- Defining Clinical Evidence Requirements for digital health products from patient, payer, and regulator perspectives.
- Navigating AI in Medical Devices – balancing innovation, risk, and patient access.
- Designing Clinical Studies for Software-Based Devices – enhancing engagement and data quality.
- Ethics and Bias in AI – promoting fairness, transparency, and accountability.
- Real-World Evidence and Post-Market Surveillance – maintaining safety and compliance amid continuous software updates.
Tom Melvin presented on early feasibility studies (EFS) for AI-enabled and digital health technologies.
He highlighted that these technologies often have different needs and objectives during early feasibility compared to traditional implantable medical devices. Understanding clinical validity for products brought to market using synthetic or historic data, and examining how digital health solutions integrate with clinical workflows, are critical steps in ensuring effective and safe adoption.
Findings from a recent JMIR publication were also shared, demonstrating that EFS for digital health technologies is valuable but remains underutilized in current research and development practices.
Alongside Tom Melvin’s presentation, Jennifer Braten Jackfrom MediTrials introduced progress on protocol template development, designed to streamline clinical investigations and promote greater consistency across studies.
Why This Matters
As AI and digital health solutions continue to transform healthcare, robust regulatory frameworks and reliable clinical evidence are vital to ensure patient safety while accelerating innovation.
The CSMD-Horizon Conference 2025 provided a collaborative forum to exchange insights, address emerging challenges, and shape the future of MedTech and digital health.
We Were There: ISPOR Europe 2025 – Advancing Early Feasibility Studies in Europe
On 10 November 2025, we led the session “Implementing a Program for Early Feasibility Studies in Europe: Goldmine or Fools Gold?” at ISPOR Europe 2025 in Glasgow. The session brought together key stakeholders to explore how a harmonised Early Feasibility Studies (EFS) programme could support safer, faster, and more efficient medical device development under the EU Medical Device Regulation (MDR).
Why EFS Matters
With MDR raising the bar for clinical evidence, traditional feasibility or pivotal trials often face delays or failures due to late-stage design issues. EFS, conducted earlier in the development cycle, can:
- Improve patient safety
- Enable smarter trial design
- Reduce development costs
- Accelerate time-to-patient
The U.S. FDAs EFS programme has already demonstrated these benefits. The HEU-EFS project aims to bring similar value to Europe by proposing a harmonised EU-level framework.
Session Highlights
The session featured a dynamic panel of experts:
- Tom Melvin, University of Galway
- Marta Kerstan, Johnson & Johnson MedTech
- Lucía Feito Allonca, HEU-EFS Patient Advisory Group (PAG)
- Moderator: Maria Luisa Buzelli, Bocconi University
Key themes included
- Harmonisation of application processes across EU Member States
- Structured early dialogue between sponsors and regulators
- R&D support to de-risk innovation
- Building awareness and expertise among patients and clinicians
- Transparency and open data to build trust
- Inclusion of patient voices throughout the study lifecycle
- Addressing the specific needs of digital health technologies
Our Contribution
We also presented our poster: “National Competent Authorities Experiences with Early Feasibility Study Assessment”
The poster highlighted
- The lack of a harmonised EFS approach across NCAs
- The importance of early dialogue and sponsor preparedness
- The need for standardised templates and improved documentation
- Challenges in ethics approval processes
- The value of coordinated assessment pilots for shared learning
What’s Next?
The HEU-EFS consortium announced a Call for Pilots to test the proposed methodology and a Call for Papers to further the academic and policy dialogue.
We are excited to continue supporting this important initiative and look forward to collaborating with regulators, HTA bodies, industry, and patient organizations to shape the future of EFS in Europe.
Learn more: https://heuefs.eu/open-call-for-pilots/
#ISPOREurope #HEUEFS #MedicalDevices #MDR #ClinicalResearch #HealthPolicy #MedTech #HTA #Innovation #PatientSafety #RegulatoryScience #EarlyFeasibilityStudies
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
| Time | Theme | Speaker |
| 15.00 – 15.05 | Introduction | Rosanna Tarricone, Bocconi University |
| 15.05 – 15.15 | HEU-EFS Methodological Framework | Alexandra Poulsson, Norwegian Institute of Public Health |
| 15.15 – 15.35 | HEU-EFS Pilots | Manon Gielkens, MEDTRONIC Giuditta Callea, Bocconi University Fanny van der Loo, Edwards Lifesciences |
| 15.35 – 15.55 | Interactive Q&A | Fanny van der Loo, Edwards Lifesciences Giuditta Callea, Bocconi University Tom Melvin, University of Galway Alexandra Poulsson, Norwegian Institute of Public Health |
| 15.55 – 16.00 | Next steps and closing | Giuditta Callea, Bocconi University |
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
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.
The HEU-EFS project
HEU-EFS is a four-year European project called Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union, which started in October 2023 and involves 22 public and private organisations across Europe.
The project is co-funded by the Innovative Health Initiative (IHI) under the Horizon Europe Framework Programme and 6 industry partners for a total budget of €19 million. The overall goal of the initiative is to develop a harmonised methodology and enhance the uptake of EFS in the EU. For more information, please visit www.heuefs.eu.
Call for expression of interest
HEU-EFS consortium is pleased to announce the launch of an open call for pilots to validate the methodological framework of the harmonised approach to EFS for medical devices in the EU.
As a first step, under this call, pilot proposers are invited to submit Expression of Interest online form to indicate their interest to conduct an EFS pilot study using methodology developed by the HEU-EFS consortium.
The pilot will provide innovators with a unique opportunity to take their innovations via a pilot structured EFS regulatory process. Particularly, the participants will:
- Obtain guidelines and templates for EFS submissions along with structured early engagement with the National Competent Authorities (NCAs).
- Benefit from a unique learning opportunity and engage with our consortium experts.
- Contribute feedback that will influence the development of the future EU EFS programme.
Who can apply and eligibility conditions
Sponsors wishing to conduct pilot EFS clinical investigations in Europe who meet the following criteria:
1. The clinical investigation must be consistent with the definition of Early Feasibility Study as per ISO 14155:2020.1
2. They must be a high-risk devices (Class III and Class IIb), where a clinical investigation will be required as part of the conformity assessment.
3. They must meet at least one of the following criteria:
- Breakthrough Device/Unmet Need – utilized to collect early clinical data when no equivalent device exists.
- Anatomical understanding – utilisation of the EFS to better understand physiology and anatomical limitations of the device under development.
- New /Expanded intended uses or indication for use – the application of an existing/approved device in a new patient population or application
- They must request approval in at least one European country (i.e. countries within the EU or European Economic Area).
Submission of the call of interest
Applications should be submitted by completing and sending the online form no later than March 31, 2026.
The data provided will be handled as strictly confidential. It will be stored by Bocconi University (project coordinator) and accessible to members of the Screening Committee.
For any questions regarding the Open call for pilots, please contact the HEU-EFS Point of Contact at pilot@heuefs.eu.
Process
The Expressions of Interest will be assessed by the Screening Committee, coordinated by Bocconi University to review matching of the pilots with the scope of the methodology framework and proposer’s readiness.
Proposers and members of the Screening Committee will meet online (30-minute) and discuss the expressed interest.
After positive assessment, proposers will be provided with the list of next steps and with a link for submitting a self-evaluation checklist via the online system QualtricsXM provided by Bocconi University.
Once an applicant is selected for the pilot, the Point of Contact will make available an information package and training outlining the next steps and providing instructions and templates. No services will be provided on the conduct of the clinical trial implementation. Proposers should finance their own studies. No public funding will be available from Innovative Health Initiative or from HEU-EFS consortium.
Learn more
Resources
Find all project deliverables here.
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
