A New Member Joins the EFORT Team!
We are pleased to welcome our new EU Advocacy Project Officer, Anouck Barba, to the EFORT team! Anouck will focus on European affairs, working primarily on the MedTechLabel and COMPASS4MD projects. She is a lawyer admitted to the French Bar by training, with a strong background in European Law.
Ongoing Projects
We are excited to share an update on the ongoing projects and initiatives in which EFORT is currently involved. Through these initiatives, we contribute clinical expertise, foster cross-sector collaboration, and advance research, science, and policy engagement in orthopaedics and traumatology across Europe.
The MedTechLabel Project
EFORT is proud to contribute to MedTechLabel, an innovative public-private partnership supported by the Innovative Health Initiative (IHI). The project’s mission is to create a unified, standardised digital labelling framework specification covering all classes of Medical Devices (MD) and In Vitro Diagnostics (IVD).
Professors Per Kjaersgaard-Andersen, Theofilos Karachalios, and Rob Nelissen are actively lending their expertise to the project. As the task leader for Work Package 1, EFORT has developed a template to collect use-case scenarios from diverse user groups, which will directly feed into the ongoing work of Work Package 2.
The “COMPASS4MD” Project: Comprehensive Optimisation of Methodologies for Patient-centric Assessment and Safety Standards in Medical Devices
Led by the Delft University of Technology and funded by Horizon Europe, the COMPASS4MD project was launched following key insights from the CORE-MD project, in which EFORT was deeply involved.
CORE-MD demonstrated that high-risk medical devices are frequently approved with limited clinical evidence, highlighting persistent challenges for regulators and notified bodies in evaluating evidence adequacy. COMPASS4MD addresses these hurdles by developing clear methodologies and practical tools to define, evaluate, and harmonize clinical evidence requirements—supporting more consistent and transparent regulatory decision-making.
EFORT leads the coordination of expert panel involvement, the development of practical guidance and training for regulatory stakeholders, and the execution of multi-stakeholder workshops to ensure new evaluation methodologies remain clinically relevant.
Looking Ahead
These initiatives provide valuable opportunities to exchange knowledge, build strategic partnerships, and deliver long-term impact for European healthcare. We look forward to sharing further milestones as these projects progress!
