RAPS Texas Chapter Meeting

Speaker: Susan Mecca, Senior Medical Technical Manager – Americas, LRQA

The new EU IVDR will replace and repeal the existing IVD Directive 98/79/EC when it is published, currently expected during the second quarter of 2017. With the aim of tightening and strengthening the approval system for IVDs, the new regulation introduces a number of important changes, including:

  • Scope of regulated IVDs
  • Classification and conformity assessment requirements
  • Person responsible for regulatory compliance
  • Identification and traceability
  • Performance evaluation report
  • Vigilance and market surveillance
  • Notified Bodies
  • Timetable for introduction and transition

Come join us to learn how you can proactively prepare for the introduction of, and transition to, the new EU regulation once it comes into effect.

Register here