RAPS Texas Chapter: EU In Vitro Diagnostic Device Regulation—Are You Prepared for the Changes?

Come engage with professionals from your local regulatory community over dinner and hear an interactive presentation on the new EU In Vitro Diagnostic Device Regulation (IVDR) in the European Union. This event is coordinated by the RAPS Texas Chapter and is intended to encourage knowledge sharing and community development. A meal will be provided. RAC holders may claim 1.5 RAC recertification credits.

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.

Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.