Export Medical Devices Without CE Marking: An Overview
Exporting medical devices without CE marking can be a strategic move for manufacturers targeting markets outside of Europe. While CE marking is typically required for medical devices sold within the European Economic Area (EEA), many countries outside this region have their own regulatory requirements. You can export your medical devices to non-European countries using ISO 13485 and local Free Sale Certificates (FSCs), bypassing the need for CE marking and its associated complexities. Here’s a comprehensive guide on how to navigate exporting medical devices without CE marking
Want to know more about ISO 13485 and CE marking? Read our service page on CE marking for medical devices and ISO 13485.

Tips for Successful Exporting Without CE Marking
Understand Local Regulations
Work with Local Representatives
Prepare Documentation
Compliance with Standards
Stay Updated
Exporting medical devices without CE marking requires thorough preparation and understanding of the regulatory requirements in each target market. By following these tips and leveraging local expertise, manufacturers can successfully navigate the complexities of international markets and expand their global footprint effectively. This initiative opens new opportunities for growth and market expansion. Connect with us to learn more about this simplified process and how Operon Strategist can support your global market strategy.