While it may be possible, I don't recommend it. Specifically, if the Basic UDI-DI and UDI-DI are identical, then it negates the fundamental intent of a Basic UDI-DI. For example, the MDCG reminds us that the Basic UDI-DI is independent/separate from the packaging/labelling of the device. Thus, if we make the Basic UDI-DI the same as the UDI-DI (which identifies a packaging level among other things), then we lose that intended separation. I also think having them the same is a recipe for mix-ups and confusion. It also has only limited practical value because each level of packaging requires its own UDI-DI thus forcing the organization to manage different UDI-DI numbers anyway as soon as you have multiple packaging configurations (which sales and marketing often at some point decides are needed).
That said, the MDCG also reminds us, and in particular the issuing agencies, that the Basic UDI-DI format should be as close as possible to that for the UDI-DI so that the Basic UDI-DI won't differ to significantly from the UDI-DI.
On that note, like Dan said, the two numbers you gave actually aren't the same, but are quite similar. Thus, it appears you are on the right track.
------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
------------------------------
Original Message:
Sent: 17-Jan-2024 19:00
From: Dan O'Leary
Subject: Basic UDI-DI & UDI-DI
In your example, they are not the same. The Basic UDI-DI is B-123654, while the UDI-DI is 123654.
The Basic UDI-DI is for a family of devices, each of which has its own UDI-DI. You make the assumption that there will be, forever, only one device in the family. However, as you make changes to the device, you will need additional UDI-DIs to represent versions or models. Therefore, the Basic UDI-DI should be more descriptive of the family, not of only one device.
Because you ask about the Basic UDI-DI, you are in the EU system. The EU has four issuing agencies, while the rest of the world seems to have three. Forming the Basic UDI-DI and the UDI-DI requires that you follow the issuing agency rules. If you market the device in the US, then you cannot use the German issuing agency recognized by the EU. However, you could, it seems, use a Basic UDI-DI from one issuing agency and UDI-DIs from another.
In any case, the rules to form the Basic UDI-DI and the rules to form the UDI-DI are different, so your scheme might not work. Also, as your device family grows, your method will, eventually, be awkward.
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 17-Jan-2024 11:25
From: Anonymous Member
Subject: Basic UDI-DI & UDI-DI
This message was posted by a user wishing to remain anonymous
Hello RAPS Community,
Can Basic UDI-DI be exactly the same number as UDI-DI, eg. Basic UDI-DI : "B-123654" and UDI-DI: "123654"?
Thank you for explanation!