UDI assignment and labeling.

[cool1984]

I have a question about UDI assignment and labeling.

My medical device (eg biological monitor) consists of several components/parts.
Imagine a relationship like a main unit and a power cable of a mobile phone.

If the medical device is distributed in one package. I will assign and label UDI as a whole.
However, if the main unit and power cable packages are distributed separately, should I assign and label UDIs for each?

Note)
Actually, the same quantity arrives at the customer, but it is assembled and used by the customer.
Also, the medical device is usually used with the power cable attached at all times.

 

[Junn1992]

You have one BUDI and UDI for the entire system.

In addition, for parts the qualify as devices under the MDR, they each have their own individual BUDI and UDI as well.

Ref MDCG 2018-3

"Under the conditions set in Article 22(4), systems and procedure packs are to be treated as devices in their own right"

Scenario 1: Everything is packaged together

- System Level UDI appears on overall packaging containing all the parts (excluding shipping container)
- Individual accessory UDI appears on the boxes holding individual components and/or on the devices themselves

Scenario 2: Everything is shipped separately

This gets complicated.

Annex VI Part C
Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI

6.3.3. Placement of the UDI carrier on systems or procedure packs (a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging. (b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.

So because everything is shipped separately, and there is no "overall packaging" for the entire medical device system....where does the system level UDI appear? :O

Hope someone has the answer

 

[cool1984]

You have one BUDI and UDI for the entire system.

In addition, for parts the qualify as devices under the MDR, they each have their own individual BUDI and UDI as well.

Ref MDCG 2018-3

"Under the conditions set in Article 22(4), systems and procedure packs are to be treated as devices in their own right"

Scenario 1: Everything is packaged together

- System Level UDI appears on overall packaging containing all the parts (excluding shipping container)
- Individual accessory UDI appears on the boxes holding individual components and/or on the devices themselves

Scenario 2: Everything is shipped separately

This gets complicated.

Annex VI Part C
Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI

6.3.3. Placement of the UDI carrier on systems or procedure packs (a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging. (b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.

So because everything is shipped separately, and there is no "overall packaging" for the entire medical device system....where does the system level UDI appear? :O

Hope someone has the answer

Thank you for your reply& follow up.
The point of this challenge is that the power cable can attach to both main unit A and main unit B.
Main unit A and main unit B may have different UDI-DIs (assuming the same Basic UDI-DI as it is confusing)
Even in this case, I think that the power cable is a components/parts of the main units A and B, but I am wondering if that is all right from the viewpoint of UDI. Because there are many similar cases to power cables, we are looking for justification that this cable does not have to display the UDI as a component / part of a medical device.

 

[Swimming In The Soup]

I would think the cable would have a UDI as the system is not operable without it. However, I am confident that it would be exempt from marking based on the space available for labeling.

Unit Of Use
A base package usually contains only one device. However, in some instances there may be more than one. For example, a box may contain 100 examination gloves or 25 adhesive bandages. The individual glove or bandage will not have a UDI, but there will be a UDI on the box. A hospital, for example, needs to distinguish between using one glove on a patient and using a box of 100. To solve this problem, the manufacturer assigns a “unit of use” DI and loads it into GUDID so that it links to the base package DI.

Kits
A convenience kit is multiple different medical devices packaged together for the convenience of the user. This could include procedure trays, IVD kits, etc.

The convenience kit requires a UDI on the kit’s label. However, the individual devices inside the kit do not need a UDI. The UDI on the kit label is sufficient. For example, a surgical procedure tray would require sterilization, but a UDI on the items in the tray could interfere with sterilization of the devices in the kit.

If the device in the kit were sold separately (perhaps as a replacement), then it would require a UDI on the base package label.


Source:

Med Device Online (website)
A Guide To Device, Label, And Package Requirements Of The UDI Rule
By Dan O'Leary, President, Ombu Enterprises

 

[yodon]

I guess I'm a glutton for punishment but let me get in on this discussion because these things seem to keep coming up.

I am confident that it would be exempt from marking based on the space available for labeling.

"Flag" labels are easy enough to add to a cable and give reasonable space for markings. Since the cable is separable, doesn't that mean that it needs at least some identification to link it to the product (or maybe just company)?

Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI

A convenience kit is multiple different medical devices packaged together

I don't see how a cable can be considered a device (or even accessory). It's a necessary component of the system (sounds like).

This isn't exactly an isolated case. Plenty of devices have replacement components (especially power cables!) that aren't a device and aren't an accessory. Somebody *has* to have the answer!