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

Información del proyecto

HEU-EFS

Identificador del acuerdo de subvención: 101112185

DOI

10.3030/101112185

Fecha de la firma de la CE 25 Octubre 2023

Fecha de inicio 1 Octubre 2023

Fecha de finalización 30 Septiembre 2027

Financiado con arreglo a

• Health

Coste total

€ 19 008 438,75

Aportación de la UE

€ 10 532 197,50

Coordinado por

UNIVERSITA COMMERCIALE LUIGI BOCCONI
Italy

Periodic Reporting for period 2 - HEU-EFS (HARMONISED APPROACH TO EARLY FEASIBILITY STUDIES FOR MEDICAL DEVICES IN THE EUROPEAN UNION)

Período documentado: 2024-10-01 hasta 2025-09-30

Resumen del contexto y de los objetivos generales del proyecto

The EU mandates a lifecycle approach for generating clinical evidence for health technologies, requiring demonstrable added value compared to standard care at market authorization. Early Feasibility Studies (EFS) play a critical role in this process by gathering relevant data early on to inform business cases and improve evidence generation. However, EFS adoption in the EU is limited due to a lack of standardized procedures, unlike the US, where the FDA's EFS program has been successful. The EU aims to create a harmonized EFS framework, recognized as a strategic priority under the EU4HEALTH Program. The Harmonised Approach to Early Feasibility Studies for Medical Devices in the EU (HEU EFS) project, launched in October 2023, aims to formulate recommendations for the establishment of an EFS Program within the EU, with a focus on ensuring patient safety and enhancing the EU single market competitiveness.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

The HEU-EFS project (https://heuefs.eu/) has made significant progress towards developing an EU harmonised framework for Early Feasibility Studies (EFS) for medical devices. Initial activities focused on building the evidence base for the programme through a systematic review of pre-market clinical investigation pathways, the development of dedicated databases (PMAP-DB and EFS-DB), and surveys to identify challenges in medical device approval processes. The consortium also completed a comprehensive review of the EU regulatory landscape and digital health technologies and assessed the capacity of National Competent Authorities (NCAs) through interviews and targeted surveys. These activities informed the development of the HEU-EFS methodological framework, including eligibility criteria for the EFS programme, covering technologies, medical conditions, and clinical sites. More information from the activities mentioned above is available here: https://heuefs.eu/deliverables/
Building on this work, the consortium ensured meaningful patient involvement through the Patient Advisory Group (PAG), which has been engaged throughout the project to ensure that patient perspectives are reflected in the development of the HEU-EFS framework and tools. Patient Engagement Plans (PEPs) were developed, and partners provided ethical and legal support, including informed consent materials and engagement with ethics committees. A major achievement was the development of a standardised Clinical Investigation Plan (CIP) template, integrating regulatory requirements, stakeholder feedback, and patient perspectives. Following extensive consultation with consortium partners and external stakeholders, the final CIP template and accompanying checklist were completed and made publicly available through the project website (https://heuefs.eu/deliverables/).

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

Not applicable at this stage.