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

Project Information

HEU-EFS

Grant agreement ID: 101112185

DOI 10.3030/101112185

EC signature date 25 October 2023

Start date 1 October 2023

End date 30 September 2027

Funded under

• Health

Total cost € 19 008 438,75

EU contribution € 10 532 197,50

Coordinated by

UNIVERSITA COMMERCIALE LUIGI BOCCONI
Italy

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Documents, reports (6)

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.

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 (3)

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

Author(s): C Federici, FL Zurlo, R Tarricone, G Callea
Published in: Value in Health, Issue 27, 2024, ISSN 1098-3015
Publisher: Elsevier BV
DOI: 10.1016/j.jval.2024.10.2528

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

Author(s): 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
Published in: Value in Health, Issue 27, 2024, ISSN 1098-3015
Publisher: 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?

Author(s): 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
Published in: Value in Health, Issue 27, 2024, ISSN 1098-3015
Publisher: Elsevier BV
DOI: 10.1016/j.jval.2024.10.1524