Exporting to Europe | Navigating the CE Mark Process for Life Science Companies

Join us on Tuesday, May 27 from 10-11:00 am 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 MethodSense, a North Carolina company, will be joined by a representative from a leading European notified body to share foundational guidance for companies entering the EU medical device market. The session will also highlight key regulatory considerations for devices that incorporate Artificial Intelligence. This webinar is ideal for early-stage or export-ready companies planning to expand into Europe.

This session is organized by Global Life Sciences Opportunities Business Exchange (GLOBE), 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.

Topics Covered:

• 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.

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