Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,

Yes, it sounds like some kind of miscommunication. GS1-US​ does provide identifiers for US organizations, and those identifiers work just fine in the US and EU UDI schemes.

https://www.gs1.org/sites/default/files/docs/healthcare/position-papers/gs1_udi_guide_final_20170324.pdf

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 26-Jun-2019 03:31
From: Anonymous Member
Subject: EU UDI for MDR and designated issuing entities

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,

The issue probably relates to the Basic UDI-DI which is only required by the new EU regulations. The rest of the world does not use the concept.

There was another thread in this forum about the Basic UDI-DI which cited the GS1 implementation. The link is to a GS1 document from Germany.

The FDA doesn't require a Basic UDI-DI, so a US source may not have the information. In particular, the Basic UDI-DI does not go on any packaging or labeling; it is only in EU documents and databases such as the DoC or the device registration database.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 26-Jun-2019 03:31
From: Anonymous Member
Subject: EU UDI for MDR and designated issuing entities

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,

Have to agree with Dan, it was probably maybe talking about Basic UDI-DI.  Because this is only related to European MDR 2017/745, we are creating the Basic UDI-DI only to the company - it will have nothing to do with the Issuing Entities.  We have developed a process for UDI in Europe where each Product Family is assigned the Basic UDI-DI internal to the company where we have a spreadsheet with all the assigned UDI-DI and then based on the individual devices, there is a column then having our Basic UDI-DI listed.  At first I was quite annoyed Europe did something like this but after doing many product portfolio reviews I can see the essential of this to finally establish a Product Family for the finished medical device.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 26-Jun-2019 19:13
From: Dan O'Leary
Subject: EU UDI for MDR and designated issuing entities

The issue probably relates to the Basic UDI-DI which is only required by the new EU regulations. The rest of the world does not use the concept.

There was another thread in this forum about the Basic UDI-DI which cited the GS1 implementation. The link is to a GS1 document from Germany.

The FDA doesn't require a Basic UDI-DI, so a US source may not have the information. In particular, the Basic UDI-DI does not go on any packaging or labeling; it is only in EU documents and databases such as the DoC or the device registration database.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 26-Jun-2019 03:31
From: Anonymous Member
Subject: EU UDI for MDR and designated issuing entities

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,

Richard's comments notwithstanding, the Basic UDI-DI applies to both the EU-IVDR and the EU-MDR. In addition, the rules for the Basic UDI-DI do come from the issuing agencies.

I've attached the current MDCG document, the GS1 document, and the HIBC document. I don't have the corresponding information for the other two issuing agencies.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 27-Jun-2019 06:22
From: Richard Vincins
Subject: EU UDI for MDR and designated issuing entities

Have to agree with Dan, it was probably maybe talking about Basic UDI-DI.  Because this is only related to European MDR 2017/745, we are creating the Basic UDI-DI only to the company - it will have nothing to do with the Issuing Entities.  We have developed a process for UDI in Europe where each Product Family is assigned the Basic UDI-DI internal to the company where we have a spreadsheet with all the assigned UDI-DI and then based on the individual devices, there is a column then having our Basic UDI-DI listed.  At first I was quite annoyed Europe did something like this but after doing many product portfolio reviews I can see the essential of this to finally establish a Product Family for the finished medical device.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 26-Jun-2019 19:13
From: Dan O'Leary
Subject: EU UDI for MDR and designated issuing entities

The issue probably relates to the Basic UDI-DI which is only required by the new EU regulations. The rest of the world does not use the concept.

There was another thread in this forum about the Basic UDI-DI which cited the GS1 implementation. The link is to a GS1 document from Germany.

The FDA doesn't require a Basic UDI-DI, so a US source may not have the information. In particular, the Basic UDI-DI does not go on any packaging or labeling; it is only in EU documents and databases such as the DoC or the device registration database.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 26-Jun-2019 03:31
From: Anonymous Member
Subject: EU UDI for MDR and designated issuing entities

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,

​All;

We have encountered the same from GS1 US so I contacted GS1 Belgium.  Was of course told to contact GS1 US as we are a US based manufacturer.

The message from GS1 (both times we have contacted them) was the same; no process to support EU MDR UDI.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States
------------------------------

Original Message:
Sent: 26-Jun-2019 03:31
From: Anonymous Member
Subject: EU UDI for MDR and designated issuing entities

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,

According to the Official Journal 7.6.2019 page 75 the UDI Issuing Agences for the EU-MDR and the EI_IVDR are:

GS1 AISBL
Health Industry Business Communications Council (HIBCC)
ICCBBA
Informationsstelle für Arzneispezialitäten - IFA GmbH

A Google search says, "GS1 AISBL is an international non-profit association registered in Belgium, with offices at Avenue Louise 326, box 10, 1050 Brussels (Enterprise number: 419.640.608)."

You should contact them to determine any information about the EU.


------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 27-Jun-2019 08:27
From: Shelley Looby
Subject: EU UDI for MDR and designated issuing entities

​All;

We have encountered the same from GS1 US so I contacted GS1 Belgium.  Was of course told to contact GS1 US as we are a US based manufacturer.

The message from GS1 (both times we have contacted them) was the same; no process to support EU MDR UDI.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States

Original Message:
Sent: 26-Jun-2019 03:31
From: Anonymous Member
Subject: EU UDI for MDR and designated issuing entities

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,

​When the GS1 representatives say they have "no process to support EU MDR UDI", I wonder what question they're trying to answer. Because really it's the manufacturer that needs a process to comply with the EU MDR UDI rules.

Pretty much all the issuing agencies need to do is supply a company identifier and an algorithm for calculating check digits. That's their business, and they do it all the time. And they even supply helpful brochures to manufacturers with advice about how to manage their EU and US UDI processes.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 29-Jun-2019 13:41
From: Dan O'Leary
Subject: EU UDI for MDR and designated issuing entities

According to the Official Journal 7.6.2019 page 75 the UDI Issuing Agences for the EU-MDR and the EI_IVDR are:

GS1 AISBL
Health Industry Business Communications Council (HIBCC)
ICCBBA
Informationsstelle für Arzneispezialitäten - IFA GmbH

A Google search says, "GS1 AISBL is an international non-profit association registered in Belgium, with offices at Avenue Louise 326, box 10, 1050 Brussels (Enterprise number: 419.640.608)."

You should contact them to determine any information about the EU.


------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 27-Jun-2019 08:27
From: Shelley Looby
Subject: EU UDI for MDR and designated issuing entities

​All;

We have encountered the same from GS1 US so I contacted GS1 Belgium.  Was of course told to contact GS1 US as we are a US based manufacturer.

The message from GS1 (both times we have contacted them) was the same; no process to support EU MDR UDI.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States

Original Message:
Sent: 26-Jun-2019 03:31
From: Anonymous Member
Subject: EU UDI for MDR and designated issuing entities

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,

​GS1 AISBL is who I contacted who promptly told me to contact GS1 U.S...…………………...

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States
------------------------------

Original Message:
Sent: 29-Jun-2019 13:41
From: Dan O'Leary
Subject: EU UDI for MDR and designated issuing entities

According to the Official Journal 7.6.2019 page 75 the UDI Issuing Agences for the EU-MDR and the EI_IVDR are:

GS1 AISBL
Health Industry Business Communications Council (HIBCC)
ICCBBA
Informationsstelle für Arzneispezialitäten - IFA GmbH

A Google search says, "GS1 AISBL is an international non-profit association registered in Belgium, with offices at Avenue Louise 326, box 10, 1050 Brussels (Enterprise number: 419.640.608)."

You should contact them to determine any information about the EU.


------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 27-Jun-2019 08:27
From: Shelley Looby
Subject: EU UDI for MDR and designated issuing entities

​All;

We have encountered the same from GS1 US so I contacted GS1 Belgium.  Was of course told to contact GS1 US as we are a US based manufacturer.

The message from GS1 (both times we have contacted them) was the same; no process to support EU MDR UDI.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States

Original Message:
Sent: 26-Jun-2019 03:31
From: Anonymous Member
Subject: EU UDI for MDR and designated issuing entities

This message was posted by a user wishing to remain anonymous

Hi all,

I have a question regarding implementation of UDI for EU MDR. Yes we have a bit of time for the label but not so much for the Eudamed publication of different UDIs data (especially if there is an incident to be reported).

I have contacted different GS1 entities (as we are a worlwide organization) and my surprise was that GS1 US told me that they cannot support EU UDI. What a surprise? Have you encountered the same? GS1 US told me to contact GS1 EU entities... And because some GS1 EU entities might not have all of their documentation / communication in English (my experience) and that our graphical team is in US, this is not my preferred choice.

This is a surprise, as for me, the entire GS1 group was designated as an issuing entity. I will contact again GS1 as the person might have misunderstood or be incorrect however with everything around MDR enough time consuming, I was surprised to receive such an answer...

Regards,