Creating REF number for medical device

[MarRz]

Hello,

It is my company's first time making labels for medical devices. One of the information we need to put on it is the REF number. Upon research, I found out that we make it ourselves however we want, but it should uniquely identify the device. We are making a Collection Kit, that will include blood collection tube (medical device from other manufacturer) and other materials (not medical device). For the LOT and Expiry date on the label, we will include the ones from the blood collection tube, but what would be your suggestions for the REF number?

I just wanted to check here before randomly creating an alphanumeric number.

The REF number should also be put on IFU that are inside of medical device, right?

 

[BusyBee]

Hi,
This would generally be your reference code that you use to uniquely identify your kit .
So your catalogue number for that particular kit would be your REF number, on label and IFU.

Hope that helps.

 

[MarRz]

Does the REF number change, if I change the IFU content and version?

 

[BusyBee]

Does the REF number change, if I change the IFU content and version?

Hi
No the REF number is constant, unless you change the device itself.

 

[MarRz]

Hi. Thanks for replies.
I understand that REF is used to uniquely identify the kit. But how is it understood, if there is a new version of IFU in the kit. As a new kit or "the same"? I cannot imagine we would do recall based on IFU version, but this case came to my mind

We have kits on the market with "current IFU". Than we make change in IFU and new kits, that enter the market, have new version of IFU inside. What happens is, that we have two versions of IFU in the market at the same time, but all kits have the same REF number. So it is not possible to differentiate between them.

Apart from REF, we will also have UDI, LOT and Expiry date on the label, but this are also not related to IFU version.

Is that ok and acceptable, or am I missing something in my understanding of REF and other device labeling possibilities?

 

[BusyBee]

Hi. Thanks for replies.
I understand that REF is used to uniquely identify the kit. But how is it understood, if there is a new version of IFU in the kit. As a new kit or "the same"? I cannot imagine we would do recall based on IFU version, but this case came to my mind

We have kits on the market with "current IFU". Than we make change in IFU and new kits, that enter the market, have new version of IFU inside. What happens is, that we have two versions of IFU in the market at the same time, but all kits have the same REF number. So it is not possible to differentiate between them.

Apart from REF, we will also have UDI, LOT and Expiry date on the label, but this are also not related to IFU version.

Is that ok and acceptable, or am I missing something in my understanding of REF and other device labeling possibilities?

Hi
As long as the performance of the kit has not changed or you have not made any changes to the kit itself this should be ok, unless the changes to the IFU would mean that the kit is used in a different way or can give different results.
So if the changes to the IFU make no difference to overall performance this is ok,
If changes to IFU are critical to performance then you may have to recall the older versions of the kit.

 

[MarRz]

Thank you.

 

[MarRz]

Additional question, regarding brand of the package. The content is the same for two packages, that are sold under different brand. Do they have different REF number and must also be registered as different medical devices, or can it be the same? Can the manufacturer decide if he wants to group them together or not?

 

[BusyBee]

Hi, A different brand would need to have it's own REF to distinguish it from the other brand, when registering you will be asked for the brand name, if different it will be registered as 2 separate devices.

 

[MarRz]

How about point of view from marketing / connected product?

Medical device is blood collection kit (box with specific content). We register that as e.g. Blood collection package. The label on the box (bottom or side), would have medical device name and all other relevant information (REF, LOT, etc.).

Blood is collected for specific test purpose. On the top of the box would be the name of that product, e.g. Analysis 1. Can we put different product names on the box?

Example of how it would look:
Analysis 1 written on the top of the box; medical device label with name Blood collection package, REF number 1
Analysis 2 written on the top of the box; medical device label with name Blood collection package, REF number 2

My conclusion would be it is possible, since intended purpose of the medical device (package) is blood storage and transport. How it is later used (analysis) is different story. But I am not sure if this logic is ok from regulatory point of view.