Thank you for your reply. We are manufacturing IOLs. We have been printing all symbols that you listed out. My question is which symbol is printed in label, which symbol is printed in pouch, which symbol is printed in carton box and which symbol is printed in all (i.e.) label, pouch, carton box.
Hi Cinti,
You can copy symbols all over, however you will need a lot of label space...
I have a few questions that may help.
What is your intended market? North America only (US, Canada), European Community only (EU, but not the US) or both?
If the answer is the last, then the the minimum requirements are:
1. Use of symbols alone is not permitted for the North American market. product labeling using symbols
must be accompanied by a legend defining the symbols used.
2. For all medical products requirements are:
Expiration date - symbols must be on all levels.
CE Mark with Notified Body No- as above
Single use only (do not reuse) - all levels
Name of Manufacturer - as above
MFG place of business/address - as above
Lot number/batch - as above
Sterility indication - as above (with appropriate Sterility Assurance level such as 10 to -6 or 10 to -3)
Cat/Reference number - as above
Rx Only (if applicable) - as above
Storage/Handling instructions - shelf and case, but not on the unit level if label space is limited (need to do risk assessment to verify...)
Directions for use/IFU - on shelf only
Cautions - as above (information is not required if label space is limited)
If package is damaged - shelf and case only (unit level is optional)
Name and address of Authorized Representative - as above
Please let me know if you have any questions.
Regards,
Mike