C
CBGus
I hope someone can help.
We have some molded parts for a medical device that have a number of bits of descriptive text on them.
My question is "Is this considered to be "labeling" and if it is, is it subject to the requirements to translate under the MDR."
Looking forward to some advice.
Regards
We have some molded parts for a medical device that have a number of bits of descriptive text on them.
My question is "Is this considered to be "labeling" and if it is, is it subject to the requirements to translate under the MDR."
Looking forward to some advice.
Regards