Amid ongoing efforts to establish a comprehensive digital health ecosystem within Europe, a new collective effort has emerged. A group of 33 digital health organizations, including a mix of industry associations and startups from several EU countries, have collectively presented a statement calling for a harmonized evaluation framework for digital medical devices by 2026. This initiative is viewed as an essential move to streamline adoption processes, reduce market barriers, and increase the continent’s competitive standing in the global digital health arena.
Europe has periodically encountered challenges related to regulatory fragmentation in digital health, which have restricted market expansion and innovation across the continent. These issues have been exacerbating for years, resulting in inefficiencies and creating unequal opportunities among EU states. Today’s call to action from digital health organizations aims to address these long-standing barriers and set the foundation for a unified approach, critical for technological sovereignty.
Why Is a Unified Evaluation Framework Urgent?
Divergent assessment systems in European countries currently stifle the scalability of digital health innovations. A centralized evaluation process is necessary for mitigating this fragmentation. Failure to resolve these discordances could lead to prolonged market entry times for innovative solutions, stalling healthcare modernization across the EU. By 2026, the coalition proposes that Europe should implement synchronized clinical and technical criteria to ensure seamless introduction and scalability of digital solutions across member countries.
What Could be at Stake for the EU’s Health Sector?
Without a collective regulatory strategy, Europe’s aspiration to sustain technological advancements in healthcare could be in jeopardy. The coalition argues that a uniform framework will not only elevate European players in the global market but will also solidify the integration of digital solutions in healthcare systems. It links the successful implementation of the European Health Data Space (EHDS) to the alignment of evaluation processes across EU states.
The urgency for reform is compounded by global technological pressures. The coalition fears that without streamlined regulatory efforts, Europe may lose its competitive edge in the fast-evolving digital health landscape. This situation could lead to a delay in the adoption of life-improving healthcare technologies across the continent.
For the coalition, the resolution lies in establishing a realistic and practical framework by 2026, which would allow European healthcare innovations to benefit the entire population without unnecessary delays. As markets like France and Germany prepare to lead this change, the coalition calls on other EU members to support the collective push for an aligned approach.
“The race for European Technological Sovereignty is happening now. We need access to a unified European digital health market – now.”
Such a framework should realistically shorten the evaluation time, ensuring that digital health technologies become accessible to EU markets within a few years post-launch. The coalition warns of consequences if these timelines extend beyond suggested limits.
“We also call for the future European evaluation framework to be truly pragmatic…Beyond this timeframe, such technologies risk becoming obsolete.”
Aligning national evaluation methods to an EU-wide standard would propel European digital health companies to a platform of equal opportunity and sustainable growth. The collaboration of stakeholders in this initiative reflects a shared concern for the stable integration of digital health across Europe’s healthcare infrastructure.
