Device - Drug Borderlines – Challenges in Europe and the USA

Description: The evolving regulatory landscape for medical devices and drug-device combination products presents significant challenges and opportunities for manufacturers. The integration of medicinal substances into medical devices, as well as novel materials with multiple modes of action, has paved the way for innovative therapies such as drug-eluting stents and anti-viral materials derived from natural sources. However, regulatory frameworks, such as the MDR’s rule 14 and recent legal decisions like Genus vs FDA, have introduced complexities in classification, compliance, and strategy development.

This session will explore these complexities by examining key borderline regulatory concepts, the implications of rule 14, and the strategic considerations for products with primary and ancillary modes of action. Additionally, participants will gain insights into the regulatory impacts of the Genus vs FDA decision on ophthalmic drug-device combination products in both the EU and US. A case study approach will provide practical strategies for navigating these challenges, optimizing regulatory submissions, and aligning commercial goals. By addressing the interplay between regulatory requirements and innovation, this session aims to empower participants to manage risks, foster innovation, and expedite product development.