EU - Does the MD label have to be harmonised?

K

kitkat

#1
Hi everyone,

This is my first time posting on the forum and I am hoping that someone will be able to help.

We are new to the world of Medical Devices and I just have a question regarding the label. We have a Class II Medical Device which we are going to sell in most EU countries and I have a question regarding the device label. Does the text have to be harmonised across all the EU countries (before translations)?
I know that certain countries require that the label is in the national language so we are going down the route of using as many symbols as possible. However I am unsure as to whether the instructions and information has to be the same in each country?

Many thanks.
 
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R

Roland Cooke

#2
I raised a Major NC on one of my clients a couple of years ago. He had English text filling one side of the IFUs, and four European languages filling the same space on the other side.

He wasn't able to justify why 75% of the text had been dropped for the other four languages.....


Bottom line, not only should the IFU translations be equivalent*, the translations should be validated in some manner.

Consider it part of your manufacturing operation responsibility, even if you outsource some/all of the translation to your distributors or suchlike.

*Equivalent does not necessarily mean identical, some things may not be best translated literally.
 
M

MIREGMGR

#3
We're continuing down the developmental path of presenting label information for a particular multinational OEM for a group of products, in 26 languages. That's their interpretation of the rules for their relatively broad area of distribution.

You gotta do what you gotta do.
 
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