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Medical Device Labeling and Symbols - US and EU Requirements

JB0424

Starting to get Involved
#1
If I have a label for a product that will be distributed in the EU and US, what are the rules on symbols?

Do I need to list all symbols in my IFU that appear on my package label? Can I omit those that are relevant to packaging only from the IFU, and only place them on the pouch labels? Furthermore, if I have a pouch within a carton, can I omit it from the carton label, and only have it on the pouch label?

I am interested in symbols such as the damaged package symbol.

I cannot find any information outlining this, but I have been told omission of particular symbols is acceptable. If anyone can point me to a particular guidance, that would be greatly appreciated as well.
 
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M

medic61

#2
Re: Labeling and Symbols

Yes, symbols are used to reduce the need for translations. You will need to purchase DIN EN 980:2008-08 to obtain them. This document does have a damaged symbol included but I cannot share it with you, you have to purchase the guideline. Just google it and I am sure you can find out where it is available.
If you have your own symbols created you must include an explanation of the symbol on or in the packaging.
Good luck!
 

JB0424

Starting to get Involved
#3
Re: Labeling and Symbols

Thanks for your response, but perhaps my initial post was unclear.

My questions is to whether I have to incorporate symbols on all packaging labels, or if it is sufficient to only have it on the primary package.

My product has a primary package (pouch), and a secondary package (carton) in which the pouch is placed inside of.

If I have a symbol pertaining to the package integrity (e.g. the damaged package symbol), then do I need to have it on both the primary and secondary packages when the labeling is intended for both the US and EU.

As a followup to that question, do those symbols have to be incorporated onto the IFU if it is a harmonized symbol?
 
M

medic61

#4
Re: Labeling and Symbols

Sorry for the misunderstanding.
We recently discussed that here as well but could not find a definitive answer. I am not able to find any quidelines for this but this is a good post so perhaps I will learn from it as well.
Thank you.
 

JB0424

Starting to get Involved
#5
Re: Labeling and Symbols

I missed that discussion, and did not come across it in my search. Perhaps that is a sign that clarification is needed from regulatory authorities.

I spoke to others in my company, and it seems that we have been shipping product in the US and EU that only has the damaged package symbol on the primary package. Also, the primary package is the only label that contains all of the symbols, having some omitted from the secondary package and IFU.

I am conforming to my company's methods, but I still prefer to understand where this reasoning comes from in case I am challenged with it from our notified body or FDA.
 

sreenu927

Quite Involved in Discussions
#6
First look for the minimum content that is required to have on the primary label, secondary label and outer packaging from the below link:
http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM095308.pdf

Then accordingly, use symbols based on the accepted symbols by US FDA from below:
http ://www .fda. gov/ downloads/ MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ ucm085679.pdf - DEAD LINK REMOVED.

For US FDA, you have a choice of using or not using the symbols. Depending upon the space (constraints/availability) on the label paper, you can choose for.

For EU, the same applies; however, translation into national languages in EU Member States is mandatory, so use harmonised symbols from EN 980 or other harmonised standards, to avoid translation cost and other label or manufacturing process costs, as symbols do not require translation. If you use the symbol either from harmonised or non-harmonised standards, the abbreviation or definition of the corresponding symbol should be included in the Instructions for use.

Regards,
Sreenu
 
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