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

Informacje na temat projektu

HEU-EFS

Identyfikator umowy o grant: 101112185

DOI

10.3030/101112185

Data podpisania przez KE 25 Października 2023

Data rozpoczęcia 1 Października 2023

Data zakończenia 30 Września 2027

Finansowanie w ramach

• Health

Koszt całkowity

€ 19 008 438,75

Wkład UE

€ 10 532 197,50

Koordynowany przez

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)

Okres sprawozdawczy: 2023-10-01 do 2024-09-30

Podsumowanie kontekstu i ogólnych celów projektu

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.

Prace wykonane od początku projektu do końca okresu sprawozdawczego oraz najważniejsze dotychczasowe rezultaty

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.

Innowacyjność oraz oczekiwany potencjalny wpływ (w tym dotychczasowe znaczenie społeczno-gospodarcze i szersze implikacje społeczne projektu)

Not applicable yet.