US EditionIVDR Regulation Made Simple: How I3CGLOBAL Empowers IVD Manufacturers for EU Compliance
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IVDR Regulation Made Simple: How I3CGLOBAL Empowers IVD Manufacturers for EU Compliance
The In Vitro Diagnostic Regulation (IVDR Regulation) – formally known as Regulation (EU) 2017/746 – marks a significant overhaul in how in vitro diagnostic (IVD) devices are regulated within the European Union. Fully replacing the older IVDD framework, the IVDR came into effect on May 26, 2017, with a mandatory compliance deadline of May 26, 2022. For medical device manufacturers, understanding the scope and structure of this regulation is essen…
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