A Notified Body’s Perspective: Managing the Impacts of EU IVDR & MDR

Managing the Impacts of EU IVDR & MDR

With the publication of the new IVDR and MDR regulations, regulatory affairs professionals and device manufacturers are seeking clarification on how to implement the new requirements within their organizations. These new regulations tighten and strengthen the approval system and introduce several key changes that manufacturers will need to implement, including:

  • Scope of regulated medical devices and IVDs
  • Identification and traceability
  • Pre-market scrutiny procedure
  • Classification and conformity assessment requirements

Download this presentation and find out answers to the industry’s frequently asked questions for a better understanding of the key changes, impacts, transition phase and steps to be taken.

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