Updates From the US and EU on Furthering the Advancements of Medical Device Development in Pediatrics

Description: Both the US and EU have begun focusing on advancing medical devices for pediatric use. In the US, the System of Hospitals for Innovation in Pediatrics (SHIP-MD) has concentrated on enhancing the medical device ecosystem to develop and innovate devices that meet children's complex needs, thereby accelerating medical device innovation for all Americans. Phase 2 of the project commenced in late 2023, with the Foundation for the National Institutes of Health leading the continuation of the initial work while introducing new ideas.

In the EU, the lack of guidance for pediatric populations has been highlighted, and regulators are grappling with determining the best way forward.

This session will help you understand what has been accomplished to date, what we can expect in the future in both regions and how this will impact market access for pediatric patients and potentially all medical devices.