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

Moderator: Louisa Stüwe, Project Director, French Ministry of Health

Speakers:

• Magali Boers, Digital Health Specialist, Ministry of Health and Social Security, Luxembourg

• Jérôme Fabiano, Deputy Director, EIT Health France

• Jari Haverinen, Senior Planning Officer, FinCCHTA

• Industry Representative (TBD)

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