Why Early Feasibility Studies Matter for Digital Health Technologies in Europe
Digital health technologies (DHTs)—including mobile apps, telemedicine platforms, wearables, and software-based clinical decision aids—are increasingly regulated as medical devices when their intended use involves diagnosis, prevention, or treatment. With rising expectations for robust clinical evidence and iterative software updates, early feasibility studies (EFSs) emerge as a potential tool to collect real-world safety, performance, and usability data at the outset of development. This article summarizes stakeholder perspectives from a qualitative interview study conducted in the European Union (EU) to understand how EFSs are used, what barriers exist, and how an EU-wide harmonized EFS program could be designed to support DHT innovation.
What the study set out to explore
The study interviewed 15 individuals from 12 DHT companies and 3 contract research organizations (CROs), spanning MDR risk classes I–III and various clinical domains. Through semistructured interviews, researchers examined how stakeholders perceive the regulatory landscape, the practicalities of planning and conducting EFSs, and how an EU harmonized EFS framework might look in practice. The focus extended to interactions with national authorities, notified bodies, and the emerging convergence with the EU AI Act.
Key findings from the stakeholder interviews
Adoption, value, and the status of EFSs in practice
Most participants recognized the theoretical value of EFSs for gathering early safety and performance signals and for enabling user-centric design iterations. In practice, however, EFSs are not routinely used. Large or AI-focused firms tended to run multiple EFS-like activities, often tied to regulatory needs for novel AI features or higher-risk classes. Smaller DHT companies, constrained by resources, frequently avoided formal EFSs and pursued alternative evidence-generation strategies.
Regulatory complexity and fragmentation as major obstacles
Stakeholders highlighted that the EU framework remains heavily hardware-oriented. MDR expectations—especially around preclinical validation and risk classification—often clash with the iterative, software-centric nature of DHT development. Unclear guidance on AI-enabled medical devices and AI feature updates within existing devices adds to the ambiguity. Fragmented regulatory requirements across member states increase costs and timelines, dampening enthusiasm for undertaking formal EFSs in the EU.
Dialogue gaps and regulatory maturity
A recurring theme was the lack of regular, constructive dialogue with regulators. Many interviewees reported limited early engagement with national competent authorities (NCAs) and notified bodies (NBs), and noted that some NBs still struggle with DHTs and AIeMDs. This absence of clear, proactive guidance fuels uncertainty and delays, pushing some companies to defer innovative features or to pursue the US market first where guidance appears clearer.
Alternatives to EFSs and the missed opportunities
Participants described alternatives such as retrospective data analyses, synthetic datasets, in silico simulations, and pilot collaborations with academic centers. While these approaches can de-risk early development and reduce costs, many argued they miss crucial human factors and real-world usability insights. EFSs are seen as the optimal path to test human–device interactions in real clinical environments and to refine both technology and workflows before larger trials.
AI Act and regulatory convergence
There is broad expectation that the EU AI Act will heighten regulatory requirements for DHTs, adding to MDR obligations. Yet stakeholders emphasize the need for clearer alignment between MDR and AI Act provisions, to avoid stifling innovation especially for SMEs. A more predictable, staged approach to AI governance could help standardize evidence requirements and reduce uncertainty for early development stages.
<h2 Toward a harmonized EU EFS program for DHTs
Respondents proposed key elements for an EU-wide, harmonized EFS framework tailored to DHTs: dedicated DHT-specific guidelines, cross‑EU harmonization of requirements, a clear EFS pathway, and a collaborative regulatory culture with predictable timelines and decision points. A central EU portal offering templates, guidelines, and updates, plus education tools and community forums, was repeatedly endorsed. Informed by international models—such as the US FDA’s EFS ecosystem and Germany’s DiGA experience—stakeholders foresee an EU approach that balances agility with robust oversight.
<h2 Implications for policy, industry, and patients
A harmonized EU EFS program could reduce fragmentation, streamline documentation, and accelerate iterative development of safe, effective DHTs. For regulators, it would promote consistent expectations and enable timely access to beneficial technologies. For industry, it could lower barriers for SMEs and foster trust in AI-enabled healthcare solutions. For patients, clearer pathways to safe, user-friendly digital health tools translate into faster access to beneficial innovations.
Conclusion
Early feasibility studies hold promise as a mechanism to support agile, evidence-based innovation in Europe’s digital health arena. Realizing this promise requires addressing MDR‑era rigidity, regulatory fragmentation, and AI-specific uncertainties through a co-designed, EU-wide EFS framework. Learning from international best practices and incorporating DHT stakeholders in the design process will be essential to creating a proportionate, flexible, and trust‑building pathway for digital health technologies across the EU.
