Structured Dialogue with the Notified Body: How to Use It Effectively

The Structured Dialogue is a key opportunity for manufacturers to clarify expectations and streamline their CE marking process under the MDR and IVDR.

Join Our Expert-Led Webinar and Gain Crucial Insights On:

  • How to use the Structured Dialogue to your advantage
  • What types of questions bring value
  • What to avoid
  • How to prevent incomplete submissions that cause major delays

Tom photo

Tom Patten is the IVD International Manager at GMED. He brings broad and varied experience from within the in-vitro diagnostics sector, having worked in laboratories, product development, and R&D for molecular oncology devices. Over the past seven years, he has also gained notified body experience, contributing to the successful designation of an IVD body under the IVDR 2017/746. In his current role, Tom supports manufacturers with global IVDR/IVD regulatory strategy, structured dialogue sessions, and international market access.

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