HARMONISED APPROACH TO EARLY FEASIBILITY STUDIES FOR MEDICAL DEVICES IN THE EUROPEAN UNION

Informations projet

HEU-EFS

N° de convention de subvention: 101112185

DOI

10.3030/101112185

Date de signature de la CE 25 Octobre 2023

Date de début 1 Octobre 2023

Date de fin 30 Septembre 2027

Financé au titre de

• Health

Coût total

€ 19 008 438,75

Contribution de l’UE

€ 10 532 197,50

Coordonné par

UNIVERSITA COMMERCIALE LUIGI BOCCONI
Italy

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (8)

EU EFS Clinical Investigational Plan

Standard clinical protocol for conducting EFS in the EU.

EU regulatory framework and international standards

Research report summarizing the current EU regulatory framework for clinical evidence generation for MDs and DHTs and relations with the future EU EFS Program.

Professional and organizational characteristics of competent authorities

Report on CAs’ professional and organizational capacities and gaps to fulfil for a successful EU EFS program.

Research report summarizing the current EU regulatory framework for clinical evidence generation for MDs and DHTs and relations with the future EU EFS Program.
Characteristics and state of play of EFS

Research report summarizing the findings of the empirical investigation on individual EFS impact on lifecycle evidence generation and MDs safety.

Recommendations for HEU-EFS on state of play of regulatory framework and institutional and organizational characteristics of EU competent authorities

Paper summarizing the main findings on the state of play of the regulatory framework and organization of clinical evidence generation programs in the EU and recommendations for the development of the EU EFS methodology (open access).

Characteristics, gaps, and best practices of premarket programs

Research report summarizing the findings of the systematic review on premarketprograms, including finding from surveys and interviews.

Eligibility criteria and patient contribution to EFS

Research report summarizing recommendations regarding EU EFS Program eligibility criteria and patients’ role and contribution to EFS.

Websites, patent fillings, videos etc. (2)

HEU-EFS Online Portal

Freely accessible HEU-EFS online portal.

Educational content for research and analysis activities

Educational content (e.g. live and pre-recorded training sessions, short video tutorials, executive summaries, informative documents) for the stakeholders involved in the research and analysis activities such as surveys, focus groups or interviews.

Publications

Conference proceedings (4)

MT58 Use of Early Feasibility Studies to Inform Development of Medical Devices

Auteurs: C Federici, FL Zurlo, R Tarricone, G Callea
Publié dans: Value in Health, Numéro 27, 2024, ISSN 1098-3015
Éditeur: Elsevier BV
DOI: 10.1016/j.jval.2024.10.2528

MT13 Challenges of Pre-Market Clinical Investigations of Medical Devices: A Multi-Stakeholder Perspective

Auteurs: Giuditta Callea, Rosanna Tarricone, CARLO FEDERICI, Helen Banks, Maria Luisa Buzelli, Francesco Benito Malandrini, Franco Luigi Zurlo, Marta Kerstan, Monica Tocchi, Nicolas Martelli, Tess Martin, Ornella Tangila Kayembe, Stephane Piat, Laura Sampietro-Colom, Andrea Rappagliosi, Claudia Louati, Yasemin Zeisl, Daniel Bèltran, Adrián Valledor, Marta Bragagnolo, Marit Erna Austeng, Alexandra Herborg Cornelius Poulsson, Kristian Kidholm, Lise Kvistgaard Jensen, Benedetta Brancadoro, Carmen Furno, Sebastian Kuhn
Publié dans: Value in Health, Numéro 28, 2025, ISSN 1098-3015
Éditeur: Elsevier BV
DOI: 10.1016/J.JVAL.2025.04.1123

HPR67 Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization Across 55 Jurisdictions

Auteurs: FB Malandrini, G Callea, R Tarricone, M Kerstan, L. Sampietro-Colom, A Valledor, A Balsamo, D Catania, S Vainieri, M Tocchi, O Tangila Kayembe, T Melvin, A Poulsson, S Kuhn, A Rappagliosi, P Auclair, M Gielkens, C Santin, R Roijers, L Kvistgaard Jensen
Publié dans: Value in Health, Numéro 27, 2024, ISSN 1098-3015
Éditeur: Elsevier BV
DOI: 10.1016/j.jval.2024.10.1494

HPR98 The EU Regulatory Framework for Medical Device Early Feasibility Studies: What Do We Know to Date?

Auteurs: T Melvin, N Martelli, S Kuhn, O Tangila Kayembe, I Michaelis, M Peseke, A McDonnell, F Murphy, M Geraghty, H Banks, G Callea, R Tarricone
Publié dans: Value in Health, Numéro 27, 2024, ISSN 1098-3015
Éditeur: Elsevier BV
DOI: 10.1016/j.jval.2024.10.1524

Peer reviewed articles (1)

Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study

Auteurs: Marlen Peseke, Ilja Michaelis, Ornella Tangila Kayembe, Majella Geraghty, Ali McDonnell, Franco Luigi Zurlo, Zoe Sophie Oftring, Nicolas Martelli, Tom Melvin, Sebastian Kuhn
Publié dans: Journal of Medical Internet Research, Numéro 27, 2025, ISSN 1438-8871
Éditeur: JMIR Publications Inc.
DOI: 10.2196/77982