Labeling requirements for single use devices

R

Riya Gupta

Starting to get Involved
#1
#1
Hello all!
Can anyone please tell me about the UDI related requirement for single use devices which are not sold as single unit but in a multipack. So, I know about FDA and EU MDR requirements that UDI is not mandatory on single packed device label but still I would like to confirm whether still there is any requirement to put lot no. On each single packed device label???

Thanks in advance for your contributions to this.
 
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Zero_yield

Zero_yield

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#2
#2
Edit: Ah, dang. I just noticed you mentioned the UDI thing already.

I think you want to review Part C. The terms you're looking for are "unit of use" and "single-use".

For example:

4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.
Click to expand...
So there are definitely times where you need to have UDI on the individual device, and times when it can just be on the carton of the multipack.

The company I work for has a multipack product that has the lot number on every single packed device label, but it also has some formats where the product is sold "loose". Having the each device labeled is also just helpful for product segregation for our process specifically, as it's a very manual process.
 
E

ECHO

Involved In Discussions
#3
#3
I couldn't find any specific requirements but in the past, we labeled each single packed device with the Lot Number, even though units were not sold as single units.
 
John C. Abnet

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#5
#5
ECHO said:
I couldn't find any specific requirements but in the past, we labeled each single packed device with the Lot Number, even though units were not sold as single units.
Click to expand...
Consistent with what @ECHO stated.....regardless of the requirements, be selfish. In other words, ...make sure that your organization (and customers) are protected and root cause can be identified. I.e. if something goes wrong with a product what traceability/history does your organization want/need to limit exposure?

Hope this helps.
Be well.
 
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