Medical Device Label - Language

M

marqueser

Registered
#1
#1
Hi,

We have some doubts about interpretation and good understanding regarding the information to appear on the label of medical devices.

Under the directive, the competent authority required us to include, in addition to the product's commercial name, the general name of the product (eg Minnie wheelchair - commercial name + general name of the device).

Currently, the MDR states, in Annex I 23.2, that the label must include the name or trade name. Analyzing this point, we understand that we can start using only the commercial name (which does not need to be translated into different languages). In the example, we would just use Minnie.

However, point 23.2 b) states that it must contain information that is strictly necessary for users to identify the device. Could this point indicate the need to include the name of the product (in the example, wheelchair)?

I would like to get your opinion and/or how to proceed.

Thanks
 
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Ronen E

Ronen E

Problem Solver
Moderator
#2
#2
marqueser said:
Hi,

We have some doubts about interpretation and good understanding regarding the information to appear on the label of medical devices.

Under the directive, the competent authority required us to include, in addition to the product's commercial name, the general name of the product (eg Minnie wheelchair - commercial name + general name of the device).

Currently, the MDR states, in Annex I 23.2, that the label must include the name or trade name. Analyzing this point, we understand that we can start using only the commercial name (which does not need to be translated into different languages). In the example, we would just use Minnie.

However, point 23.2 b) states that it must contain information that is strictly necessary for users to identify the device. Could this point indicate the need to include the name of the product (in the example, wheelchair)?

I would like to get your opinion and/or how to proceed.

Thanks
Click to expand...
Strictly speaking, "information that is strictly necessary for users to identify the device" is addressed via UDI specification (it's actually a much more complete and robust identification than a generic identifier such as "wheelchair"). However, I could come up with multiple MDR clauses that require (or make it recommendable) including the word "wheelchair" at least once in a wheelchair's labeling.
 
Last edited:
M

marqueser

Registered
#3
#3
Ronen E said:
Strictly speaking, "information that is strictly necessary for users to identify the device" is addressed via UDI specification (it's actually a much more complete and robust identification than a generic identifier such as "wheelchair"). However, I could come up with multiple MDR clauses that require (or make it recommendable) including the word "wheelchair" at least once in a wheelchair's labeling.
Click to expand...
So, I need to translate the word for all languages? As we are increasingly present in different countries, I need a lot of space to put all this information (sometimes in products whose available space is limited)...
 
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