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Exporting to Europe: Navigating the CE Mark Process
May 27, 2025 @ 10:00 am - 11:00 am
Free
Join us Tuesday, May 27 from 10-11 a.m. for a practical, one-hour virtual session 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 with highlights about 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.
