HEU-EFS Project Featured in the European Heart Journal

We are pleased to announce that the HEU-EFS Project has been featured in a special article in the European Heart Journal, administered by the European Society of Cardiology. This article, part of the Digital Health and Innovation section, discusses the priorities for medical device regulatory approval and highlights our project’s efforts to develop a harmonized framework for early feasibility studies (EFS) in the EU.

Key takeaways:

• EFS can speed the development of innovative devices and investigate initial safety and performance.
• The HEU-EFS Project aims to develop an EU harmonized framework to improve the uptake of EFS.
• The European Society of Cardiology advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices addressing unmet needs and orphan cardiovascular (CV) medical devices in the EU.
• Global regulatory harmonization is essential to streamline CV medical device authorization across selected jurisdictions and enable the reprocessing of single-use devices.

Launched in January 2024, the HEU-EFS Project is a public-private partnership with 22 consortium partners working over the next four years to assess the current status of pre-market evidence generation and develop robust methodologies for EFS in the EU. Our project aims to improve the uptake of EFS and accelerate the development of innovative medical devices.

We invite you to read the whole article and learn more about our project.