Learning Marketplace

Spinal Implants: Proposed EU Reclassification and Lessons Learned from Previous Joint Reclassification

This webinar will focus on the proposed reclassification of spinal implants in Europe as documented in the draft EU Medical Device Regulation published in September 2012. Lessons learned from the previous Hip, Knee, and Shoulder Total Joint Replacements Reclassification, 2005/50/EEC, will also be covered.

Learning Objectives

  • Learn about key points and activities that will allow a smooth reclassification of a CE Marked Class IIb device to a CE Marked Class III device.
  • Gain knowledge of best practices in submitting design dossiers for Class III devices.

Who Should Attend

Medical Device Professionals working in Orthopaedic and Spine Sectors: Regulatory Professionals, Research & Development Professionals, Consultants