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MDR Workshop

Mar 25, 2019

Boston, MA or Fremont, CA .

Medical Device Regulation (MDR) Training: Practical Application for RA Professionals

The deadline to comply with the new Medical Devices Regulation (MDR (EU) 2017/745) is approaching and more device companies are starting to plan and implement their transition strategies. However, maintaining CE marking under the MDR will require ongoing, proactive effort. Internal familiarity with the regulation and how it applies to your device(s) is critical to your success in the post-MDR world.

In this two-day interactive training class, you will explore the MDR in depth, learn how to reference the MDR for answers to specific compliance questions and feel confident about those answers from Emergo’s leading MDR expert. 

Who should attend

This open training is intended for regulatory affairs staff with basic knowledge of the current Medical Devices Directive and/or Active Implantable Medical Devices Directive. Each training session is capped at 16 participants on a first come first serve basis.

The agenda comprises 15 modules that will cover:

  • Scope of the MDR
  • Specific roles of the Economic Operators (manufacturer, authorized representative, importer, distributor)
  • The concept of Eudamed and specific challenges
  • How UDI will work under the MDR
  • Conformity assessment and the role of Notified Bodies
  • Post-market surveillance, Post-market clinical follow-up, and vigilance
  • Clinical evaluation and clinical investigations
  • And MUCH more.