In my experience I've also seen confusion on this matter, so agree that it's a good question!
A non-helpful answer is 'it depends' - as it depends on the corporate setup, departments/functions who handle this type of activity, how well they are resourced, your number of products/families/SKUs, where your sites are located and which countries you sell into, etc.
For more complex situations (medium to larger companies, multiple products/families with a number of SKUs, global locations and sales) I've typically seen a part of the supply chain organization responsible for UDI at the product level (as they may have traditionally been involved with assigning GTINs or equivalent from GS1, for instance, which would still be needed for UDI). Meanwhile, Regulatory would be responsible for coordinating information transfer to the various regulatory bodies (GUDID for US, Eudamed in the EU, etc.) and/or creating regulatory-specific identifiers (B-UDI). Both would need to coordinate with other functions to appropriately implement and document (Quality may own the SOPs and sign off on records, Engineering may need to implement into the design, Manufacturing may need to adapt the printing process, etc.). A cross-functional project team is highly recommended, or at least a process to facilitate such a team for individual programs (even if you may be focused on a single product at the moment); such an established process can help avoid future questions about roles & responsibilities.
Of course consultants who specialize in UDI implementation also exist to assist with such projects (some of whom post on this board; noting that I am not in that category!) who can take on various responsibilities (including almost all of the above, if a company is open to it). You may also have to consider external parties (CMOs, Authorized Reps, etc.).
Best of luck!
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Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
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Original Message:
Sent: 17-Nov-2022 21:43
From: Vinoda Palanisamy
Subject: Poll: UDI creation at your organization
Hi Anon,
That's a great Question, I've always assumed it was the responsibility of the Regulatory Team to create B-UDI and UDI-DI and UDI- PI might be the responsibility of Engineering. I'm also trying to figure it out.
I would love to work with you to figure this out together. Please let me know if we could catch up to complete the task for both of us.
Thanks,
Vinoda
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Vinoda Palanisamy
Senior Regulatory Affairs Specialist
Dallas TX
United States
Original Message:
Sent: 16-Nov-2022 14:22
From: Anonymous Member
Subject: Poll: UDI creation at your organization
This message was posted by a user wishing to remain anonymous
The creation of UDI's at our organization is a point of contention - no one wants to take ownership of creating it when one is needed. I'm curious with other organizations, which group is responsible for creating new UDI's? (Labeling, Regulatory, Manufacturing, Operations, R&D, ect).
I'd like to create a procedure for UDI creation at our organization, listing the group responsible for the creation, but I'd like to have an idea of what other organizations do so that I have an open mind going into this. Right now its like pulling teeth trying to get one created, it takes longer to find someone to create it than to actually create it. (I'd create it myself, but I don't have access at this time).
Thank you for the input!