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FDA Delays UDI Deadline for Class I Devices to September 2022

by Francine Harris | Jul 7, 2020 | Blog

The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices.  Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for...

MDR and Class I Medical Devices – What’s In, What’s Out?

by Francine Harris | Jan 27, 2020 | Blog, Uncategorized

European Commission announced last October that the new EUDAMED will not launch until May 2022, giving everyone enough time to properly prepare for implementing M2M data exchange with EUDAMED.  Further, a grace period was also introduced by the EU for certain classes...

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