Understanding the Regulatory Context for Digital Health in the European Union
Digital health technologies (DHTs) — from mobile apps and wearables to AI-driven decision aids — are transforming how care is delivered. In the EU, these tools face a software-focused regulatory environment under the Medical Device Regulation (MDR) and an evolving AI framework. A growing interest lies in early feasibility studies (EFSs): small, real-world investigations designed to guide iterative design before full-scale trials. A recent qualitative study explored how European DHT companies and contract research organizations (CROs) perceive, implement, and to what extent they trust EFSs as part of a lifecycle approach to clinical evidence.
What EFSs Are and Why They Matter for DHTs
Traditionally used for hardware devices, EFSs are now being contemplated for software-centric and AI-enabled products. They offer early signals on safety, usability, and real-world performance, enabling rapid refinements before larger studies. The EU HEU-EFS effort aims to harmonize and pilot a standardized framework that aligns with MDR requirements while accommodating the iterative nature of DHT development. In interviews with 15 professionals from 12 DHT firms and CROs, respondents emphasized that EFSs could de-risk innovation by surfacing human–technology interactions early in the product life cycle.
Current Realities: Barriers to Adopting EFS in the EU
Despite interest, EFSs remain underutilized in Europe. Several roadblocks emerge from the interviews: the MDR is perceived as hardware-centric, with detailed preclinical validation and risk classifications that clash with the agile software development cycles of DHTs. Fragmented national requirements across member states, limited dialog with competent authorities and notified bodies, and uncertain pathways for AI feature upgrades create a confusing regulatory maze. For many SMEs, EFSs are resource-intensive, demanding specialist know-how that is not yet widely available or affordable.
Participants also highlighted the need for clearer guidance on AI components, such as AI-enabled medical devices (AIeMDs), and for better alignment between MDR and the EU AI Act. Some firms adopt a “US-first” approach, prioritizing FDA guidance and processes where EU clarity is lacking. These dynamics underscore a longer-term risk: valuable early insights may be foregone in favor of tests that fit existing hardware-oriented expectations rather than the software- and data-driven nature of modern DHTs.
What a Harmonized EU EFS Program Could Deliver
Stakeholders outlined a vision for an EU-wide EFS program tailored to DHTs. Key features include DHT-specific guidelines and harmonization across member states, a clear and predictable EFS pathway, and a culture of transparent, collaborative engagement with regulators. Timelines matter: most participants favored a 6–8 week feedback window for informal guidance, with formal decisions reserved for critical milestones.
Structural supports were repeatedly recommended: a centralized EU portal hosting templates, guidelines, and updates; educational tools and community forums; and training programs to build internal regulatory and clinical-evidence capabilities. International models were cited as instructive. The FDA’s structured EFS-like processes, along with its Digital Health Center of Excellence and Predetermined Change Control Plans, were viewed as pragmatic blueprints for Europe — provided the EU adapts them to the unique needs of software- and AI-driven health tech rather than reproducing hardware-centric norms. Germany’s DiGA framework also emerged as a relevant reference for reimbursement-oriented clarity.
Towards a Co-Designed, Proportionate Pathway
Participants emphasized co-design with digital health stakeholders to ensure proportionate requirements that reflect rapid software updates, continuous improvement, and risk-based pathways. A harmonized EU EFS could also reduce uncertainty, lower administrative burdens, and harmonize standards to facilitate cross-border research and market access. In this vision, EFSs support innovation while safeguarding patient safety and data integrity, with ongoing dialogue between innovators and regulators as a cornerstone.
Conclusion
Early feasibility studies hold promise for accelerating safe, user-centered innovation in European digital health. Yet current regulatory fragmentation and hardware-oriented expectations constrain their deployment. A harmonized, DHT-tailored EU EFS program — drawing on international practices and co-created with stakeholders — could unlock timely, iterative clinical learning, strengthen trust, and position Europe at the forefront of responsible digital health adoption.
