Preparing for EU's New
In Vitro Diagnostic Regulation

A Look Ahead for IVD Manufacturers

In May 2016, European Union (EU) institutions agreed to draft text for a new In Vitro Diagnostics Regulation (IVDR). The new regulation is expected to enter into force in late 2016, but a more realistic expectation is that it will take effect in early 2017. The new regulation brings significant changes to IVD manufacturers, suppliers, and distributors active in the EU market.

Familiarize yourself with the upcoming changes - and their potential impact on your organization - in our Market Update: Preparing for the New EU Medical Device Regulations: A Look Ahead for IVD Manufacturers.

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