Medical Devices (includes In Vitro Diagnostics)

Strategic

European IVDR: State of the Implementation

Session Leader(s)

• 

  Julien Senac, PhD

  Director, IVD Global Focus Team

Speaker(s)

• 

  Erik Vollebregt, LLM

  Partner
  Axon Lawyers

The introduction of the new IVDR will reshape the IVD market in Europe and will have a significant impact on all interested parties. During this session, participants will be informed on the latest news coming from the European Commission regarding the implementation of EU IVDR, as well as information on the designation of Notified Bodies and how the market will be impacted. This session will discuss the potential upcoming bottleneck and provide examples on how to optimize the time left prior to the full implementation of the regulation to ensure a smooth transition.

 

Learning Objectives:

• Explain the state of implementation of the European IVD regulation.
• Determine the major issues their company will face in the next coming weeks, months, and years.
• Develop a transition strategy to optimize the time left until the full implementation of the regulation.