The integration of Digital Medical Devices (DMDs), including AI-driven technologies, into healthcare systems is expanding rapidly. These innovations hold the potential to enhance patient care, refine diagnostics, and improve operational efficiency. However, several barriers hinder their seamless adoption:

• Regulatory Ambiguity: Complex and evolving regulatory landscapes can delay the commercialization of DMDs.

• Lack of Standardized Evaluation Criteria: Disparate assessment frameworks across different nations and regions create inefficiencies.

• Economic and Financial Constraints: Existing reimbursement and funding models struggle to adapt to the rapid pace of technological progress.

• Limited Integration into Healthcare Practices: The absence of DMDs in healthcare pathways leads to hesitancy among professionals in adopting these solutions.

A Global Approach to Regulatory Pathways

This session will present preliminary findings from the European Taskforce for Harmonised Evaluation of Digital Medical Devices (EvalEUDMD), focusing on:

• The development of a standardized EU classification and evidence matrix to assess DMDs based on their function, application, and required supporting data.

• Evaluating the implications of the Health Technology Assessment Regulation (HTA R) on market access.

• Exploring the regulatory differences between the EU and USA and strategies to navigate these frameworks effectively.

Panel Discussion

This session aims to provide actionable insights into streamlining regulatory processes, fostering innovation, and ensuring that DMDs achieve optimal patient and healthcare system benefits.