Italian Health Economics Association (AIES) XXIX Annual Conference

Setting Up a Harmonized Framework for Early Feasibility Studies in the European Union: What Value(s)?
Italian Health Economics Association (AIES) XXIX Annual Conference

At the XXIX Annual Conference of the Italian Health Economics Association (AIES), Session VIII focused on “Setting Up a Harmonized Framework for Early Feasibility Studies in the European Union: What Value(s)?”. The session brought together several speakers to discuss regulatory, methodological, and practical aspects of Early Feasibility Studies (EFS) for medical devices.

Chair: Giuditta Callea

Speakers included:

• Helen Banks – “Pre-market clinical investigations of medical devices: European regulatory framework and international standards”
• Maria Luisa Buzelli – “Challenges and barriers to pre-market clinical investigations of medical devices: a systematic literature review”
• Francesco Malandrini – “Pre-market approval pathways for clinical investigations of medical devices: a global perspective”
• Franco Luigi Zurlo – “State of the art of Early Feasibility Studies for medical devices”

The session provided insights into the current landscape of pre‑market clinical investigations, existing challenges, and the evolving approach to harmonizing Early Feasibility Studies within the European Union.