HEU-EFS Annual Meeting 2026: Advancing Early Feasibility Studies in Europe

From 5–7 July 2026, the HEU-EFS consortium gathered in Oslo, Norway, for its Annual Meeting, hosted by the Norwegian Institute of Public Health (NIPH) and the Norwegian Medical Products Agency (NoMA). The event brought together consortium partners, regulators, industry representatives, patient organisations, healthcare professionals, and members of the Advisory Board to review project progress and discuss the future of Early Feasibility Studies (EFS) in Europe.

The meeting began with internal and satellite sessions on adapting the HEU-EFS framework to Digital Health Technologies (DHTs) and exploring incentives for research and development in the European Union. These were followed by two days of presentations, panel discussions, and interactive sessions covering project achievements, pilot activities, regulatory developments, dissemination, and the evolving European medical device landscape.

A key focus of the programme was the implementation of the HEU-EFS framework through pilot activities, with stakeholders sharing experiences and discussing opportunities to improve evidence generation for innovative medical devices. Dedicated sessions also explored the adaptation of the framework for Digital Health Technologies and recent developments related to the Medical Device Regulation (MDR).

The meeting also featured a Young Scientists Session, where PhD researchers presented their work on topics including clinical investigations, digital medical devices, regulatory frameworks, and market access, highlighting the important contribution of early-career researchers to the project.

The Annual Meeting concluded with discussions on the consortium’s next milestones and future activities. HEU-EFS thanks all speakers, participants, and organisers for their valuable contributions and continued commitment to advancing innovation in medical device research across Europe.