Examining the evolving dynamics between EU and FDA regulations for medical devices. The webinar will address the historical practice of obtaining a CE Mark in Europe first, contrasting it with the current trend where companies are increasingly opting for U.S. clearance or approval first. Insights will be provided to help companies decide on the most suitable regulatory path. 

Attend this webinar and learn:

• The differences between the obligations in the MDD and those in the MDR
• The differences between the obligations imposed by EU and US rules
• The extent to which US data may be leveraged in the EU

Sponsored by: 

Speakers:

Elisabethann Wright

Senior Counsel, Steptoe LLP

Elisabethann Wright specializes in EU law and regulation of pharmaceuticals, medical devices and digital health, food and cosmetic products. With 40 years in practice she supports clients through the procedures and regulations necessary to place and keep their products on the European Union market through strategic advice, advocacy before institutions and agencies and litigation before EU and EFTA courts. Her experience covers the full regulatory life cycle of medical devices.

Omar Ford - Moderator

Editor-in-Chief, MD+DI