Online Survey for Sponsors of Medical Device Clinical Investigations

Introduction
Sponsors of pre-market clinical investigations for medical devices are invited to participate in an online survey conducted as part of the Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) project (Grant Agreement no. 101112185).

Funded by the Innovative Health Initiative (IHI), HEU-EFS aims to develop a robust, standardized methodology and set recommendations to streamline Early Feasibility Studies (EFS) within the EU.

Establishing a clear, harmonized framework for EFS in the EU is expected to benefit patient access, innovation uptake and investment attractiveness in Europe.

Survey
This survey focuses on pilot pre-market clinical investigations (CI) to assess a medical device early in its development phase. These include first-in-human, early feasibility, and traditional feasibility clinical investigations. When answering, please consider specifically the challenges of planning, monitoring and conducting CI in Europe.

Take the survey https://bit.ly/HEU-EFS_Survey

The survey will be open until 11 November.
The results will be presented in a dedicated webinar and on the HEU-EFS project webpage.