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In Vitro Diagnostic Regulation (IVDR) Booklet: All key information in one document

This booklet offers a full overview of the In Vitro Diagnostic Regulation (IVDR), including the latest amendments and updates.

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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
  • TÜV NORD diagrams illustrating the conformity assessment pathways under the IVDR

Who is the IVDR booklet intended for?

This booklet is particularly suitable for manufacturers of in vitro diagnostic devices, healthcare institutions, and other professionals involved in diagnostic testing: In short, for anyone working with or affected by the IVDR.

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