Tag: MDR
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EU Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies
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…
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EU Stakeholder Perspectives on Early Feasibility Studies for Digital Health
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…