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First of all, let me start off by saying I'm not a regulatory expert by any means. I work for a medical device manufacturer that sells product to distributors for distribution all across the EU. The product that we distribute is a line of disposable, single use equipment covers (sterilized) within a pouch. I have been told that our labeling must accomodate 23 languages as well as some international symbols such as "Do Not Reuse".
Some of our equipment covers go within a 6" x 10" pouch and get labeled on the outside appropriately. We have discovered that it is almost impossible to label such a small area with such a large amount of information. I've been told it's mandatory to label at the pouch (and not just box) level.
I am wondering if somebody can confirm or point me in the right direction on the EU / CE Mark label language translation requirements. I find it difficult to understand how so much language translation needs to fit on individual packaging for the operating room for medical devices. Before we go down this road I'd like to feel confident that the information I've been given is correct.
I thank you in advance.
Some of our equipment covers go within a 6" x 10" pouch and get labeled on the outside appropriately. We have discovered that it is almost impossible to label such a small area with such a large amount of information. I've been told it's mandatory to label at the pouch (and not just box) level.
I am wondering if somebody can confirm or point me in the right direction on the EU / CE Mark label language translation requirements. I find it difficult to understand how so much language translation needs to fit on individual packaging for the operating room for medical devices. Before we go down this road I'd like to feel confident that the information I've been given is correct.
I thank you in advance.