Country of origin - Made in EU or Made in Finland?

MDD_QNA

Involved In Discussions
#1
We are working on our labels that do not have COO mark (Made in country) on it and we are having discussions on whether to put the actual country where the product is made (which in this case is Finland) or if it is ok to write EU as the country of origin. What is your take on it? Everything is produced in Finland, we (as legal manufacturer) have our offices in another country in EU. So should we write Made in EU or Made in Finland? And why?
 
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twanmul

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#2
The requirements within the GSPR for labels are:
"the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;"
You are only required to put the address of the registered place of business. You may complicate things by adding information about where you actually manufacture it.
The questions I'd ask are: i. How much does it matter; ii. Do I have the space on the label; iii. Is this likely to cause confusion in the event of enacting vigilance processes?
This sounds more like something you might be better putting in your IFU, however please consult your relevant HS for information to be provided with the device as I'm only familiar with ISO18113, with mainly working on IVD Medical Devices.
 
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