Mandatory Label Signs on Product

F

FredLaBosche

#1
Except from IFU / Package -
Does anyone know if there are any symbols (e.g. warning signs, reference to IFU, storage) mandatory to be put on MDD class IIb device product label?

Thanks in advance for helping!
 
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T

The Specialist

#2
I don't know of any mandatory label 'signs'.

Signs used shall be determined by risk assessment and applicable risk reporting regulations/ COSHH assessment etc...

Specific storage condition/time instructions shall be determined through stability study.

What are the risks related to your product?


Please await further advice from other forum members though... my experience with medical devices is not as great as many others here.
 
F

FredLaBosche

#3
Thanks for the answer.

I may go in more detail. Current symbols according to DIN980 on the IFU are
- temperature limit
- manufacturer
- lot
- use by
- caution - keep away from children
- refer to IFU

The product label itsel is much smaller so the question is if it is possible to remove some symbols on the product label or do all symbols that are on in the IFU and the package labe have to be on the product label as well?
 

somashekar

Staff member
Super Moderator
#4
Except from IFU / Package -
Does anyone know if there are any symbols (e.g. warning signs, reference to IFU, storage) mandatory to be put on MDD class IIb device product label?

Thanks in advance for helping!
These come from your product standards and its associated standards concerning to labels sign which together are your harmonized standards. The MDD (Annex I, section 13) gives you good directions and lets you to decide and you have your NB to discuss with in detail.
Consider it more as information needed to use the device safely and properly. This information comes from both Label and Instructions for use
 
Last edited:
T

The Specialist

#5
Thanks for the answer.

I may go in more detail. Current symbols according to DIN980 on the IFU are
- temperature limit
- manufacturer
- lot
- use by
- caution - keep away from children
- refer to IFU

The product label itsel is much smaller so the question is if it is possible to remove some symbols on the product label or do all symbols that are on in the IFU and the package labe have to be on the product label as well?

I see,

So your question is related not just to 'signs' but also 'general' label requirements (e.g. lott no etc..), ok.

My understanding is that the lott no and expiry and product specific information such as 'keep away from children' are a must.

It may be possible to use a datamatrix or similar for other non-mandated information.

Again,
I would await further responses to this query.

I believe there was a similar thread to this not too long ago that may answer your question... I will see if I can find it and link it for you...
 
#7
You mention you are using DIN980. That, I presume, is the German version of EN 980 which is a harmonised standard under MDD.

My list of places to look for labeling requirements starts with the MDD, then adds 60601-1 and 60601-1-2 (EMC) each of which adds extra requirements.

Then add US requirements etc etc.
 
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