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CORDIS - Resultados de investigaciones de la UE
CORDIS

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

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

EU regulatory framework and international standards (se abrirá en una nueva ventana)

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 (se abrirá en una nueva ventana)

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. (se abrirá en una nueva ventana)
Characteristics and state of play of EFS (se abrirá en una nueva ventana)

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 (se abrirá en una nueva ventana)

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 (se abrirá en una nueva ventana)

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

Eligibility criteria and patient contribution to EFS (se abrirá en una nueva ventana)

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

HEU-EFS Online Portal (se abrirá en una nueva ventana)

Freely accessible HEU-EFS online portal.

Educational content for research and analysis activities (se abrirá en una nueva ventana)

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.

Publicaciones

MT58 Use of Early Feasibility Studies to Inform Development of Medical Devices (se abrirá en una nueva ventana)

Autores: C Federici, FL Zurlo, R Tarricone, G Callea
Publicado en: Value in Health, Edición 27, 2024, ISSN 1098-3015
Editor: 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 (se abrirá en una nueva ventana)

Autores: 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
Publicado en: Value in Health, Edición 27, 2024, ISSN 1098-3015
Editor: 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? (se abrirá en una nueva ventana)

Autores: 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
Publicado en: Value in Health, Edición 27, 2024, ISSN 1098-3015
Editor: Elsevier BV
DOI: 10.1016/j.jval.2024.10.1524

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