This episode provides a comprehensive guide to CE Marking for medical devices, a mandatory certification for accessing the European Economic Area. We cover the essential requirements, including device classification, Quality Management Systems, technical documentation, conformity assessments by Notified Bodies, clinical evaluations, the role of the EU Authorized Representative, and post-market surveillance. Learn about the benefits, such as expanded market access and enhanced patient safety, as well as key considerations like ongoing compliance under regulations like MDR 2017/745 and IVDR 2017/746.

Key Questions:

• What is CE Marking and why is it essential for medical devices in Europe?

• How does the EU's Medical Device Regulation (MDR 2017/745) impact CE certification?

• What are the different risk classifications for medical devices and how do they affect the CE process?

• What is the role of a Notified Body in obtaining CE Marking?

• What key documentation, like the Technical File and Clinical Evaluation Report, is required?

• Do non-EEA manufacturers need a European Authorized Representative?

• What are the ongoing responsibilities after a device receives its CE mark?

• How does CE Marking contribute to patient safety and broader market access?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.