Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

Per the recently published MDCG 2021-1, Guidance on harmonized administrative practices and alternative technical solutions under EUDAMED is fully functional, the assigned Basic UDI-DI shall be provided to the UDI database prior to placing the device on the market.

I'm curious what UDI database other companies are going to use. Will GDSN add a field for the Basic UDI-DI? 

Thank you!

If you are using service from GS1 then they have added a field already, check their website .

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Monoj Kalita PhD
Senior RA Specialist
New Taipei City
Taiwan
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Original Message:
Sent: 04-Mar-2021 16:08
From: Anonymous Member
Subject: Basic UDI-DI prior to EUDAMED

This message was posted by a user wishing to remain anonymous

Hi all,

Per the recently published MDCG 2021-1, Guidance on harmonized administrative practices and alternative technical solutions under EUDAMED is fully functional, the assigned Basic UDI-DI shall be provided to the UDI database prior to placing the device on the market.

I'm curious what UDI database other companies are going to use. Will GDSN add a field for the Basic UDI-DI?

Thank you!