The challenging rollout of EU MDR and a limited number of Notified Bodies have device companies concerned about expiring certifications. The EU Commission has extended the transition deadline. Orthopedic OEMs will have until the end of 2027 or 2028 to conform to quality, safety and performance assessments of the devices they introduce to the European market. In this informative panel discussion, regulatory experts and representatives from Notified Bodies discuss how companies should respond to the extended transition period and start implementing the new regulatory framework to meet the MDR’s robust requirements.
Learning Objectives:
• Understand the MDR’s requirements and ways to navigate the latest extension
• Learn about taking a proactive approach to starting the Notified Body process
• Find out how to best work with a Notified Body to meet the new transition deadlines
