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 1 - HEU-EFS (HARMONISED APPROACH TO EARLY FEASIBILITY STUDIES FOR MEDICAL DEVICES IN THE EUROPEAN UNION)

Período documentado: 2023-10-01 hasta 2024-09-30

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 has made significant progress across several work packages. The partnership conducted a systematic review of pre-market clinical investigation pathways, developed databases (PMAP-DB and EFS-DB), and launched surveys to identify challenges in medical device approval processes. The team then completed a comprehensive review of EU regulations and digital health technologies, with planned interviews and a survey to assess the capacity of National Competent Authorities (NCAs). The consortium focused also on developing eligibility criteria for the EFS Program (including criteria for technologies, medical conditions, clinical sites), established a Patient Advisory Group (PAG), and created Patient Engagement Plans (PEPs). A standard Clinical Investigation Plan (CIP) template was also drafted, integrating feedback and regulatory insights. Partners cooperated to provide ethical and legal support, finalized informed consent for PAG members, and held coordination meetings with ethics committees. Preparation began as well as for pilot use-cases, aligning industry partners and timelines to ensure smooth implementation.

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 yet.