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ViewAttendees 16

Pharmaceuticals

Domain: Product Development & Registration

Knowledge Area: Regulatory Guidance

MDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and Industry

Thursday, May 11, 2023
13:45 – 14:45 CEST
Location: Pearl 2

Supported By
Description: The session will give an update about the implementation and interpretation of MDR Art. 117 regarding Drug-Device combination products after 2 years experience. What is the state of play? What has been changed since last year? What are the updates regarding guidances and what are the results of workshops and meetings? How has collaboration between the stakeholders evolved? Are challenges i.e. regarding Notified Body Opinion, device platforms, life cycle management and co-packaged medical devices solved and how? And what to expect in future?
Update will come from regulatory authorities (to be confirmed), notified body and industry which give their specific insight in the topic.

Learning Objectives:

  • Participants understand the current state of play and experience with the MDR/IVDR implementation from regulatory, notified body and industry perspective for development and life cycle management of combination products.
  • Participants to understand challenges of pre- and post-market requirements and how they that have been overcome or are still remaining and describe existing tools for the development of combination products
  • Participants to understand the complexity of the approval of combination products and how collaboration of all stakeholders is key