Medical Device Molded Parts with Text on Them

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
 

AgnieszkaSz

Involved In Discussions
If there is an indentation in injection moulding tool, such text is usually called "marking". We have such requirements for some parts (they are directly on the drawing) and the customer doesn't treat it as labels. Besides, they are difficult to change - apart from date stamp. Depends on the function such marking provides. In doubt, I would ask the customer for clarification.
 

shimonv

Trusted Information Resource
MDR Definition:
‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;

Is your product a device or component? if its a component, then most likely translation requirements are not applicable.

Shimon
 
C

CBGus

Thank you both,

It is a class IIb medical device so I believe that it will be subject to translation. We also have a class Ia device where I believe translation is not required.

Thanks again
 
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