adv_webdev
Starting to get Involved
Hi,
We make medical devices (non-IVD, class 2, some 1) that sell in US as well as in EU and other international markets.FDA require that we explain all the symbols in English Text - this might create a problem when we market this in Europe as all non-english text on the label will need translation. This will end up in making the label too large for the product packaging to hold.How are you working around this issue for your products?
Any suggestions greatly appreciated.
P.
P.S. In the past, FDA was agreeable to having the explanation of symbols in the IFU (labelling). Now, the scrutiny is much stricter and they are requiring this on the label.
We make medical devices (non-IVD, class 2, some 1) that sell in US as well as in EU and other international markets.FDA require that we explain all the symbols in English Text - this might create a problem when we market this in Europe as all non-english text on the label will need translation. This will end up in making the label too large for the product packaging to hold.How are you working around this issue for your products?
Any suggestions greatly appreciated.
P.
P.S. In the past, FDA was agreeable to having the explanation of symbols in the IFU (labelling). Now, the scrutiny is much stricter and they are requiring this on the label.