Regulatory Open Forum

Hi James

I believe that's correct, as far as the regulatory requirements go.
MDD DoC's don't have Basic-UDI-DIs on them.
And nobody can enter UDI data into EUDAMED yet, since it isn't available. And UDI labeling on devices isn't required In Europe for a few more years. 

On the other hand, a tender can have its own requirements. Some customers have been requesting GTINs on everything for years now.

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 06-Feb-2020 06:54
From: James Bonds
Subject: EU UDI Requirements

Hi All,

I need a sanity check here.  It is my understanding that if a firm is continuing to market under the MDD during the transition period, UDI labeling is not required.  However, since the first of the year I have had multiple requests from potential distributors and for tender offers that are requesting UDI information.  Am I correct in my thinking that the UDI requirements are not applicable to devices CE marked under the MDD during the transition period?  The devices are Class 1 sterile.

Thanks,

James

Hi James,
Also to add to Anne's response below, the UDI requirements don't apply for Class I devices until Sep 2020, for the US market anyway

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Carolyn Gannon
Cork
Ireland
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Original Message:
Sent: 06-Feb-2020 06:54
From: James Bonds
Subject: EU UDI Requirements

Hi All,

I need a sanity check here.  It is my understanding that if a firm is continuing to market under the MDD during the transition period, UDI labeling is not required.  However, since the first of the year I have had multiple requests from potential distributors and for tender offers that are requesting UDI information.  Am I correct in my thinking that the UDI requirements are not applicable to devices CE marked under the MDD during the transition period?  The devices are Class 1 sterile.

Thanks,

James

In addition, some countries are already requiring UDI like Netherlands and Turkey.  The implementation of UDI for Europe is a phased approach starting in 2021 with Class III devices regardless whether EUDAMED is up and running.  I would still plan on getting UDI compliance for MDD products because that will be a tough discussion with local regulatory authorities or a Notified Body.  Regardless, if your company is selling in the U.S. you should already have a compliant UDI system.  The only difference is when EUDAMED is functional, there will be another database to enter information.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Feb-2020 03:33
From: Carolyn Gannon
Subject: EU UDI Requirements

Hi James,
Also to add to Anne's response below, the UDI requirements don't apply for Class I devices until Sep 2020, for the US market anyway

------------------------------
Carolyn Gannon
Cork
Ireland

Original Message:
Sent: 06-Feb-2020 06:54
From: James Bonds
Subject: EU UDI Requirements

Hi All,

I need a sanity check here.  It is my understanding that if a firm is continuing to market under the MDD during the transition period, UDI labeling is not required.  However, since the first of the year I have had multiple requests from potential distributors and for tender offers that are requesting UDI information.  Am I correct in my thinking that the UDI requirements are not applicable to devices CE marked under the MDD during the transition period?  The devices are Class 1 sterile.

Thanks,

James