Power Cable - UDI - EU & USA

ParisTommy

Starting to get Involved
Hello,

I have a question that has been discussed a bit in the forums, but I don't think the question has been answered fully.

Description
I have a medical device acessory "The Box".
"The Box" is a reusable non sterile active medical device accessory.
It is connected to a disposable sterile single use device, "The Handle".
"The Box" regulates the power sent to "the handle", it has embedded LEDs, which light up when "The Handle" is in use and can signal an error (e.g. orange "error" LED).

It will be placed on the USA & EU market initially, but with a view to expansion.
"The Box" needs to be plugged into the mains power supply, using a cable like the photo attached.
The whole ensemble will be tested for electrical safety as per 60601.

1703089614591.png


Regulatory Strategy
USA "The Handle" will be submitted via the De Novo pathway (so class II) "The Box" will be included in this De Novo submission. FDA presub meeting confirmed this pathway.

EU "The Box" device is an accessory, according to the MDR it will be an active class I device. (non sterile, non measuring, reusable but not a surgical instrument) it will have a dedicated technical file.
The Handle and The Box will have seperate Basic UDI-DIs.

Our UDI supplier is HIBCC
"The Handle" has its own UDI-DI, UDI-PI and is distributed seperately. No UDI questions for "The Handle"


Question : How to manage the UDI for "The Box" and specifically the different versions of the power cable?

Scenario 1 - Kit

  1. A UDI-DI is attributed to the
    1. cable US,
    2. cable EU,
    3. The Box,
    4. Kit EU (Kit =Box+cable)
    5. Kit US
  2. Several units of "The Box (no cable)" are produced, no cable is present. "The Box" is labelled with a sticker with the UDI-DI, UDI-PI datamatrix.
  3. Several EU and USA cables are purchased and stocked. (these are off the shelf items)
  4. At the moment of the order, the customer specifies what cable they require (either a box to tick on the website, a question by phone, email etc).
  5. The warehouse agent places "The Box (no cable)" labeled with "The Box" UDI-DI UDI-PI into a carton.
  6. The warehouse agent selects the appropriate cable (EU / USA) and places it in the carton.
  7. The lot N° of the cable and The Box are recorded (this constitutes the manufacturing history for the kit).
  8. A label is added to the box detaling the contents (kit) with a new UDI-DI and UDI-PI.
Final product :
A carton with a UDI-DI (e.g. Kit US) and UDI-PI (e.g. Lot N° for the kit preparation), inside, a cable (e.g. US cable) and "The Box" with a UDI-DI and UDI-PI label

Advantages: stock handling flexible
Disadvantages: have to add another UDI to the kit box.

Question: Do we need to label the cable?

Scenario 2 - Not a Kit
  1. A UDI-DI is attributed to the
    1. The Box with cable EU
    2. The Box with cable US
  2. Several units of "The Box with cable EU" and "The Box with cable US" are produced.
  3. "The Box" is labelled with a sticker with the UDI-DI, UDI-PI datamatrix.
  4. The outer carton is labelled with the same UDI-DI UDI-PI
  5. Several EU and USA cables are purchased and stocked. (these are off the shelf items)
  6. At the moment of the order, the customer specifies what cable they require (either a box to tick on the website, a question by phone, email etc).
  7. The warehouse agent selects the correct item and ships it.
Final product :
A carton with a UDI-DI (e.g. The Box US) and UDI-PI (e.g. the box serial N°), inside, a cable and "The Box" with the same UDI-DI and UDI-PI label

Advantages: Fewer UDIs to manage, no "Kit Preparation" step.
Disadvantages: stock handling not flexible. especially when we have UK, Swiss, Australia other markets...
Can't easily rework a devce from one market to another, because need to rework and relabel "The Box"


Scenario 3 - Chill out - it's just a cable !
  1. A UDI-DI is attributed to the box
  2. Several units of "The Box" are produced.
  3. "The Box" is labelled with the UDI-DI, UDI-PI datamatrix.
  4. Several EU and USA cables are purchased and stocked. (these are off the shelf items)
  5. At the moment of the order, the customer specifies what cable they require (either a box to tick on the website, a question by phone, email etc).
  6. The warehouse agent selects "The Box" and picks the right cable, tosses it in the shipping carton and ships it.
Advantages: Fewer UDIs to manage, no "Kit Preparation" step.
Disadvantages: The cable is an integral part of the device, it won't work if we forget to send a cable, what about recalls in case of a faulty US cable / EU cable?


What do you think?

Have a nice day :)
 
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