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

Reporting period: 2023-10-01 to 2024-09-30

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 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.

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 yet.