HEU-EFS at The MedTech Forum 2026: Advancing Early Feasibility Studies in Europe

rom 11–13 May 2026, the HEU-EFS project joined leading innovators, policymakers, researchers, patient representatives, and industry stakeholders at The MedTech Forum 2026 in Stockholm to discuss the future of medical technology in Europe.

As part of the event, HEU-EFS hosted a panel discussion titled:

“Accelerating Early Feasibility Studies for Medical Devices in Europe”

Moderated by Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), the session brought together a diverse group of experts representing patient advocacy, academia, regulatory affairs, public health, and industry.

Panel Speakers

  • Marta Bragagnolo
  • Maria Luisa Buzelli
  • Karin Fricke
  • Tom Melvin
  • Alexandra Poulsson

The discussion explored how a harmonised European framework for Early Feasibility Studies (EFS) could help accelerate innovation while improving patient access to breakthrough medical technologies.

Panelists shared insights on the importance of collaboration between public and private stakeholders through the Innovative Health Initiative (IHI), highlighting how coordinated efforts can strengthen Europe’s position as a global hub for medical device research and development.

Key themes included:

  • Improving pathways for early-stage clinical investigation in Europe
  • Enhancing collaboration across regulators, industry, academia, and patient organisations
  • Creating a more predictable and efficient EFS environment
  • Supporting faster access to innovative technologies for patients
  • Strengthening Europe’s competitiveness in medtech innovation

The session reinforced the shared commitment across the European medtech ecosystem to build a more harmonised and innovation-friendly environment for Early Feasibility Studies.

HEU-EFS, supported by the Innovative Health Initiative (IHI), continues to work toward making this vision a reality by fostering collaboration and contributing to the development of a more effective EU EFS framework.

We thank everyone who joined the discussion in Stockholm and look forward to continuing the conversation on the future of MedTech innovation in Europe.

About HEU-EFS

The HEU-EFS project aims to advance the development of a harmonised European framework for Early Feasibility Studies in medical devices, supporting innovation while ensuring patient safety and regulatory excellence.

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