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​​EC Proposal Updates on IVDR Transition & EUDAMED Rollout​

Feb 29, 2024 | Medical Devices, Unique Device Identification

Did you know? Reed Tech continually monitors global health authorities. Customers can participate in periodic webinars featuring the latest updates on legislative activity affecting requirements and exceptions for Unique Device Identification (UDI) submissions to global health authorities. Below, see some quick insights from our experts on the EC Proposal concerning the IVDR transition and proposed MDR/IVDR amendment, possibly affecting the EUDAMED rollout. These are short segments created from our latest presentation, prepared exclusively for UDI customers. 

 

Part I

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Part II

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The wheels of progress are in motion for regulatory teams planning for EU UDI compliance. When preparing and implementing a plan for UDI submissions, think globally. Start early, watch for updates, prepare your infrastructure, and finally collect and cleanse UDI data for next steps.

When you need guidance, Reed Tech is there. Questions about health authorities and Unique Device Identification (UDI)? We monitor health authorities around the globe for the latest requirements and exceptions. If you have UDI questions, we can help.