You say your devices are class IIb and Class I. I infer that there are MDD classes, not US classes. (In the US we have only three classes.) It is important to realize the US is the only place that has implemented UDI. It is not required in the EU, but probably will be some day. The implication is that you market your devices in the US, so you need to follow US rules including device classification.
In the US, the device class (and other device characteristics) determine the compliance date, but not the presentation of the UDI on the label. However there are some exceptions for Class I devices.
Answering your specific question is not easy, because it requires some knowledge of the device and its configurations. You need a different label DI when you create a new version or model. This means you have gone outside the specifications, performance, size, and composition, you have set for the device. The implicit assumption is that you have set them for the device, documented them in a quality record, and use them to determine the need for a new DI.
Although this is the technical definition, my rule of thumb says that if the customer or user would consider it different, then it needs a new DI.
Based on your description, it appears the system package is different from each of the individual displays. One simple test is the catalog number a customer would put on a purchase order. If you have a catalog number for the system package, then it would have its own DI.
If you sell a configuration (a separate catalog number) with an option, then it is different and would require a new DI.
There is a lot of confusion about accessories. In the US (as in the MDD) they are considered medial devices, and, if sold separately, might also require UDI. Unfortunately FDA has never defined accessory and in the UDI rule preamble explicitly refused to offer a definition. There is a draft guidance on this topic, but the issue is murky at best.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 11-02-2015 04:42
From: Franky Dubois
Subject: UDI labelling
Hello,
We are currently working on the implementation of the UDI labelling on our medical displays.
We have medical displays (class IIb and class I), which will all receive a unique UDI label.
Next to this we have the system package, where 2 displays are combined in a box, but here it can be that once cable A (eg Display Port) and once cable B (eg (USB) is added. Do those system levels require different UDI codes or can they still bear the UDI label referring to the medical device?
Finally same question, but adding a non medical device (as option). This can be a luminance meter or a keypad...
We want to ensure to be fully compliant with the rule, but our systems are a bit more complex than the example in the training with the catheters and their package levels
Thanks in advance
Franky
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Franky Dubois
Regulatory Officer
Barco
Kortrijk
Belgium
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