Label of a Medical Device sold in EU - Non translated information

iVivien

Starting to get Involved
#1
Hello everyone,

I was wondering if the label of a MD sold in EU could include information in a specific language (e.g. japanese) without any other translation, those information being required only for the respective country (Japan here).

For instance, "医療機器届出番号: XXXXXXXXX" which means "MD Notification number: XXXXXX", a number only applicable in Japan.

Thank you very much for your help.

Enjoy your week-end,

Vivien
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
We do some of this in respect to labeling information that is required only and specifically by US FDA. "Rx Only", for instance, is US specific in regard to its FDA legal meaning. And, US FDA does not recognize certain ISO symbols on non-IVD devices, so those ISO symbols have to have English subtext appended.

Various regulators have groused at us for our approaches to global labeling, but no one in the end has required us to change. Not so far, anyway.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hello everyone,

I was wondering if the label of a MD sold in EU could include information in a specific language (e.g. japanese) without any other translation, those information being required only for the respective country (Japan here).

For instance, "医療機器届出番号: XXXXXXXXX" which means "MD Notification number: XXXXXX", a number only applicable in Japan.

Thank you very much for your help.

Enjoy your week-end,

Vivien
Hi,

As long as that doesn't conflict with Essential Requirement 13 (MDD annex I), there should not be a problem in the EU. Just make sure that the number could not be mistaken for something else (e.g. batch number etc.).

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#4
Hello everyone,

I was wondering if the label of a MD sold in EU could include information in a specific language (e.g. japanese) without any other translation, those information being required only for the respective country (Japan here).

For instance, "医療機器届出番号: XXXXXXXXX" which means "MD Notification number: XXXXXX", a number only applicable in Japan.

Thank you very much for your help.

Enjoy your week-end,

Vivien
If you are associated with a NB for your CE notification, they will the best persons to address your query.
Annex I / 13.3 (b) the details strictly necessary to identify the device and the contents of the packaging especially for the users;
The information needed to use the device safely and properly, taking account of the training and knowledge of the potential users, is of importance.
As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself.
If I were you and a NB is not involved, I would not have such on the EU label.
 

iVivien

Starting to get Involved
#5
Thank you very much, it's always a pleasure to get answers from you !

Contacting our NB seems to be the wisest thing to do.

Have a nice day,

Vivien
 
M

MIREGMGR

#6
One approach that I've seen...though I don't yet use it myself, because it would require more label area and no one has required it of us...is to allocate some label area for bordered boxes, each of which is titled with the language-independent ISO 3166 two- or three-letter abbreviation(s) for the country name(s) to which the information in that box applies. Thus your Japan specific information would be in a box titled JP or JPN.

By doing this, one would effectively address real usability concerns, and the related possible regulator objection that a person that cannot read the language of a nationally specific content-element cannot tell that that element does not apply to them.

My view is that such an approach would be the most rigorous practical method for global-labeling conformance with conflicting national/regional labeling requirements.
 

iVivien

Starting to get Involved
#7
Indeed MIREGMGR, I see what you are describing.

I might even remember labels with an insert titled with the mention "FOR JAPAN ONLY" and containing specific information in japanese. However I am not totally sure there were medical device labels.

Thank you for your help and proposals about that question.

Vivien
 
M

MIREGMGR

#8
Note however that "FOR JAPAN ONLY" is English text and therefore could be rejected in (for instance) Quebec or many EU countries, or any other jurisdiction with a mandatory language requirement that does not include English. The use of an ISO 3166 designator, with no other words in the box-title, should avoid that issue.
 
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