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FDA Delays UDI Deadline for Class I Devices to September 2022

by Innovit Corporate Affairs | Jul 7, 2020 | Blog, UDI

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 Innovit Corporate Affairs | Jan 27, 2020 | Blog, MDR

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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  • MDR Third Amendment is official: EUDAMED Mandatory Use by January 2026
  • TGA’s Australian UDI Database: Deadline Update

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