Wednesday, 15 October 2025 | 13:15 - 14:30
B3: From theory to reality: practical approaches and regulatory framework in EU and US
Location:Room 8: Sophie
- Friederike Windisch and Nina Zimmermann: Transition to MDR/IVDR: status quo of economic operators
- Monika Hupfauf and Martin Popovic: Regulatory Fork in the Road: US or EU First? Pros and Cons
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
4 speakers
Global Head of Clinical Evidence and Safety at Roche / CEO at CATALYST SCIENTIFIC
CATALYST SCIENTIFIC GmbH