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

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

Reporting period: 2024-10-01 to 2025-09-30

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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/).

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Not applicable at this stage.