The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements for IVD manufacturers that distribute products throughout the EU. Increased regulatory oversight, expanded clinical evidence requirements and intensified supervision of Notified Bodies are just some of the major changes to be considered as compared to the previous In Vitro Diagnostic Directive (IVDD).

NAMSA’s “IVDR Readiness Guide” is intended to assist IVD organizations with a deeper understanding of key compliance steps, and to provide a clearer picture of current levels of IVDR readiness so that conformity may be met by May 2022.

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