Exporting to Europe: Navigating the CE Mark Process

This practical, one-hour virtual session is designed to help North Carolina life sciences companies understand the basic steps of obtaining CE Mark certification. Regulatory experts from North Carolina company, MethodSense, and a representative from a premier notified body for Europe will provide foundational insights for companies new to the EU medical device market, highlighting the demands on Artificial Intelligence devices in the regulatory submission process. This webinar is ideal for early-stage or export-ready companies looking to expand into the European market.

What You Will Learn:
•    The role and importance of the Conformité Européenne (CE) Mark for entering the European Union (EU) market.
•    The interplay of the Medical Device Regulation (MDR) with other European Union legislations.
•    Preparing for Notified Body (NB) conformity review process.
•    Notified Body (NB) conformity assessment process overview.
•    Top common issues for delays in the regulatory review process.

GLOBE organizes this session – Global Life Sciences Opportunities Business Exchange, an Intellectual Exchange Group with the North Carolina Biotechnology Center. GLOBE partners include the U.S. Commercial Service, Small Business & Technology Development Center, and the Economic Development Partnership of North Carolina.