RAPS Twin Cities Chapter: The EU Medical Device Regulations—Impact on Class IIb Devices and Legacy P

Wednesday, June 14, 2017, 5:30 PM - 8:00 PM CT

Come join colleagues from your local regulatory community for an evening of networking and to hear an expert presentation on the impact of the new EU Medical Device Regulations on Class IIb devices and legacy products. This event is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Dinner will be provided. RAC holders may claim two RAC recertification credits.

This interactive presentation will provide an overview of the EU MDR impact on Class IIb devices and legacy products including Notified Bodies re-designation process and transitional provisions
Specific topics to be covered include:

  • Changes to classification rules
  • New conformity assessment routes
  • Class IIb implantable devices
  • The “scrutiny process”
  • Clinical data/Evaluation/Evidence
  • Summary of clinical and safety performance
  • Postmarket surveillance and related reports