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

Informacje na temat projektu

HEU-EFS

Identyfikator umowy o grant: 101112185

DOI

10.3030/101112185

Data podpisania przez KE 25 Października 2023

Data rozpoczęcia 1 Października 2023

Data zakończenia 30 Września 2027

Finansowanie w ramach

• Health

Koszt całkowity

€ 19 008 438,75

Wkład UE

€ 10 532 197,50

Koordynowany przez

UNIVERSITA COMMERCIALE LUIGI BOCCONI
Italy

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

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.

Publikacje

Conference proceedings (4)

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

Autorzy: C Federici, FL Zurlo, R Tarricone, G Callea
Opublikowane w: Value in Health, Numer 27, 2024, ISSN 1098-3015
Wydawca: Elsevier BV
DOI: 10.1016/j.jval.2024.10.2528

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

Autorzy: 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
Opublikowane w: Value in Health, Numer 28, 2025, ISSN 1098-3015
Wydawca: 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

Autorzy: 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
Opublikowane w: Value in Health, Numer 27, 2024, ISSN 1098-3015
Wydawca: 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?

Autorzy: 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
Opublikowane w: Value in Health, Numer 27, 2024, ISSN 1098-3015
Wydawca: 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

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