K
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.
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.