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IVDR Booklet including M4

This booklet provides a comprehensive overview of the In Vitro Diagnostic Regulation (IVDR), including the latest M4 amendment.

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What are the contents of the IVDR booklet?

The Regulation (EU) 2017/746 on in vitro diagnostic medical devices (In Vitro Diagnostic Regulation – IVDR) has been mandatory since May 26, 2022 and forms the core content of this booklet. In addition, the booklet includes: 

  • practical guidance for implementing IVDR requirements
  • a sampling plan for technical documentation
  • diagrams illustrating the conformity assessment pathways under the IVDR
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