Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hi All,
Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility?
We are the legal manufacturer and our distributors are the UDI partners. Our name is on the label but my question is can we delegate UDI responsibilities to our private label partners? Can they be responsible for creating and maintaining UDI's?  

Any help or advise is appreciated. Thank you!  

I haven't seen any guidances yet about this specifically, but Annex VI, Part C, paragraph 2 states the following:

2.2. The manufacturer shall assign and maintain unique UDIs for its devices.
2.3. Only the manufacturer may place the UDI on the device or its packaging.

However, per 3.10:
3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original
device manufacturer's UDI.

This would lead one to believe that the the private label partner could label with their own UDI, but doesn't prevent the manufacturer from having to do so.  Interesting question.

------------------------------
Amy McKinney RAC
Sr Manager, Regulatory Affairs, Interventional Oncology
Fulshear TX
United States
------------------------------

Original Message:
Sent: 02-May-2019 16:11
From: Anonymous Member
Subject: EU UDI requirements

This message was posted by a user wishing to remain anonymous

​Hi All,
Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility?
We are the legal manufacturer and our distributors are the UDI partners. Our name is on the label but my question is can we delegate UDI responsibilities to our private label partners? Can they be responsible for creating and maintaining UDI's?  

Any help or advise is appreciated. Thank you!  

This message was posted by a user wishing to remain anonymous

Thank you for a quick response Amy! We are leaving space for our distributors to add their logo. Can we delegate this responsibility to private label partners for creating and maintaining UDI's?
Original Message:
Sent: 02-May-2019 19:14
From: Amy McKinney
Subject: EU UDI requirements

I haven't seen any guidances yet about this specifically, but Annex VI, Part C, paragraph 2 states the following:

2.2. The manufacturer shall assign and maintain unique UDIs for its devices.
2.3. Only the manufacturer may place the UDI on the device or its packaging.

However, per 3.10:
3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original
device manufacturer's UDI.

This would lead one to believe that the the private label partner could label with their own UDI, but doesn't prevent the manufacturer from having to do so.  Interesting question.

------------------------------
Amy McKinney RAC
Sr Manager, Regulatory Affairs, Interventional Oncology
Fulshear TX
United States

Original Message:
Sent: 02-May-2019 16:11
From: Anonymous Member
Subject: EU UDI requirements

This message was posted by a user wishing to remain anonymous

​Hi All,
Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility?
We are the legal manufacturer and our distributors are the UDI partners. Our name is on the label but my question is can we delegate UDI responsibilities to our private label partners? Can they be responsible for creating and maintaining UDI's?  

Any help or advise is appreciated. Thank you!  

A few reasons you can't and shouldn't delegate this responsibility.

1. You are the legal manufacturer (you're name is on the label, you said in your original post), so you are putting the device on the market. That products has to be compliant. Not putting a UDI on the device means that your labelling - and thus your device - is not compliant.
2. Also, you as a manufacturer are the one that has to make a declaration of conformity - with basic UDI-DI on it - and you will need to register the UDI in Eudamed. So you should define the UDI.
3. It's logical: even if it would be allowed, this would mean that various distributors could (knowingly/unknowingly) print different UDI's on the product. This eliminates the goal of UDI's: traceability across the European market.

------------------------------
Vincent van der Meer
Netherlands
------------------------------

Original Message:
Sent: 03-May-2019 09:31
From: Anonymous Member
Subject: EU UDI requirements

This message was posted by a user wishing to remain anonymous

Thank you for a quick response Amy! We are leaving space for our distributors to add their logo. Can we delegate this responsibility to private label partners for creating and maintaining UDI's?
Original Message:
Sent: 02-May-2019 19:14
From: Amy McKinney
Subject: EU UDI requirements

I haven't seen any guidances yet about this specifically, but Annex VI, Part C, paragraph 2 states the following:

2.2. The manufacturer shall assign and maintain unique UDIs for its devices.
2.3. Only the manufacturer may place the UDI on the device or its packaging.

However, per 3.10:
3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original
device manufacturer's UDI.

This would lead one to believe that the the private label partner could label with their own UDI, but doesn't prevent the manufacturer from having to do so.  Interesting question.

------------------------------
Amy McKinney RAC
Sr Manager, Regulatory Affairs, Interventional Oncology
Fulshear TX
United States

Original Message:
Sent: 02-May-2019 16:11
From: Anonymous Member
Subject: EU UDI requirements

This message was posted by a user wishing to remain anonymous

​Hi All,
Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility?
We are the legal manufacturer and our distributors are the UDI partners. Our name is on the label but my question is can we delegate UDI responsibilities to our private label partners? Can they be responsible for creating and maintaining UDI's?  

Any help or advise is appreciated. Thank you!  

MDCG has published articles on how legacy devices can be registered in Eudamed without UDI, and how device companies will have until November 2021 to register device data elements.

In addition, the EC just published three documents: UDI and device datasets to provide in Eudamed, one for IVDR, and Eudamed UDI device data dictionary.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
South Jordan UT
United States
------------------------------

Original Message:
Sent: 02-May-2019 16:11
From: Anonymous Member
Subject: EU UDI requirements

This message was posted by a user wishing to remain anonymous

​Hi All,
Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility?
We are the legal manufacturer and our distributors are the UDI partners. Our name is on the label but my question is can we delegate UDI responsibilities to our private label partners? Can they be responsible for creating and maintaining UDI's?  

Any help or advise is appreciated. Thank you!  

I can't help on guidance docs, but your suggestion could be verging near the realms of virtual manufacturing (a more onerous replacement for own brand labelling, OBL).

Do you currently outsource* any of your assembly, including labelling?

(*under suitable quality agreements - as the legal manufacturer, your company would remain liable should a contractor make a mistake)

------------------------------
Chris Barkway
Petersfield
United Kingdom
------------------------------

Original Message:
Sent: 02-May-2019 16:11
From: Anonymous Member
Subject: EU UDI requirements

This message was posted by a user wishing to remain anonymous

​Hi All,
Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility?
We are the legal manufacturer and our distributors are the UDI partners. Our name is on the label but my question is can we delegate UDI responsibilities to our private label partners? Can they be responsible for creating and maintaining UDI's?  

Any help or advise is appreciated. Thank you!  

Original Message:
Sent: 07-May-2019 12:47
From: Chris Barkway
Subject: EU UDI requirements

I can't help on guidance docs, but your suggestion could be verging near the realms of virtual manufacturing (a more onerous replacement for own brand labelling, OBL).

Do you currently outsource* any of your assembly, including labelling?

(*under suitable quality agreements - as the legal manufacturer, your company would remain liable should a contractor make a mistake)

------------------------------
Chris Barkway
Petersfield
United Kingdom

Original Message:
Sent: 02-May-2019 16:11
From: Anonymous Member
Subject: EU UDI requirements

This message was posted by a user wishing to remain anonymous

​Hi All,
Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility?
We are the legal manufacturer and our distributors are the UDI partners. Our name is on the label but my question is can we delegate UDI responsibilities to our private label partners? Can they be responsible for creating and maintaining UDI's?  

Any help or advise is appreciated. Thank you!  ​