HEU-EFS
Financiado
HARMONISED APPROACH TO EARLY FEASIBILITY STUDIES FOR MEDICAL DEVICES IN THE EURO...
EU Regulations on medical devices (MDs), in-vitro diagnostics, and Health Technology Assessment envisage a harmonised lifecycle approach for clinical evidence generation of MDs. To be effective this approach requires evidence gene...
EU Regulations on medical devices (MDs), in-vitro diagnostics, and Health Technology Assessment envisage a harmonised lifecycle approach for clinical evidence generation of MDs. To be effective this approach requires evidence generation plan to be developed since early stages of product development, by engaging all relevant stakeholders.At present, in the EU there are no standardized procedural frameworks/guidelines/common reference standards for Early Feasibility Studies (EFS), clinical investigations allowed by ISO 14155:2020 conducted early in the development aiming to inform the product development.The ambition of the HEU-EFS project is to develop a harmonised framework for the EU EFS Program, as one integrated step of evidence generation cycle. Project objectives include: (1) conducting research/analysis on state of play (i.e., characteristics, challenges, impacts) of pre-market programs for MDs, including EFS; (2) building a sustainable network of stakeholders at EU/national level to promote/support EFS implementation; (3) developing a sound, widely applicable, harmonised EU methodology and formulating recommendations to uptake EFS; (4) undertaking pilots to test the proposed framework; (5) developing instruments to monitor the EFS performance; and (6) implementing a dedicated, sustainable, open access online portal dedicated to EFS methodological framework, best practices and network.To achieve these goals, the HEU-EFS consortium has been designed including a wide range of relevant stakeholders: research organisations, HTA bodies, patient organizations, healthcare providers, SMEs (including health technology developers, legal experts, and a CRO), and 6 major private companies that are part of a pre-identified industry consortium. An Advisory Board made of competent authorities, notified bodies, medical and biomedical engineering professional associations, networks and industry trade association will collaborate to the success of the initiative.
ver más
Duración del proyecto: 47 meses
Fecha Inicio: 2023-10-01
Fecha Fin: 2027-09-30
Fecha Fin: 2027-09-30
Línea de financiación: concedida
El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2023-10-01
Línea de financiación objetivo
El proyecto se financió a través de la siguiente ayuda:
Presupuesto
El presupuesto total del proyecto asciende a
19M€
Líder del proyecto
UNIVERSITA COMMERCIALE LUIGI BOCCONI
No se ha especificado una descripción o un objeto social para esta compañía.
Perfil tecnológico
TRL
4-5
Perfil tecnológico
TRL
4-5