B3: From theory to reality: practical approaches and regulatory framework in EU and US

13:15-13:45 Friederike Windisch and Nina Zimmermann: Transition to MDR/IVDR: status quo of economic operators

This talk unveils insights from the 2nd economic operator survey conducted in the framework of the “Study supporting the monitoring of the availability of medical devices on the EU market".

13:50-14:30 Monika Hupfauf and Martin Popovic: Regulatory Fork in the Road: US or EU First? Pros and Cons

Choosing whether to launch a new medical device in the US or the EU first is a critical strategic decision that will define a product's development, budget, and global footprint. This session dissects the pros and cons of the FDA's centralized gatekeeper model versus the EU's decentralized conformity assessment. Join us to learn which path may offer advantages for your device in today's shifting regulatory and geopolitical landscape.