CE Language Requirements on labeling (both device and packaging)

[Hultermans]

I am working on requirements on labeling (both device and packaging) within the European Union (and outside). In an article I read that, when you export within the european union, the labeling has to be in the language you are exporting to. Our products have CE marks but until now the labeling has always been in English and I am wondering whether we have to change this when we are exporting to a non-English speaking country. Or can we suffice with the instructions-for-use being in the language of the country and leave the labeling in English?

Furthermore I am wondering whether there is an official reference on this topic. The Medical Device Directive (93/42/EEC) is not very clear on the language topic and the only other references I have found is not “official”. The pdf article that I found: Medical Devices in the new EU

Hope you can help me

 

[Al Rosen]

I am working on requirements on labeling (both device and packaging) within the European Union (and outside). In an article I read that, when you export within the european union, the labeling has to be in the language you are exporting to. Our products have CE marks but until now the labeling has always been in English and I am wondering whether we have to change this when we are exporting to a non-English speaking country. Or can we suffice with the instructions-for-use being in the language of the country and leave the labeling in English?

Furthermore I am wondering whether there is an official reference on this topic. The Medical Device Directive (93/42/EEC) is not very clear on the language topic and the only other references I have found is not “official”. The url of the pdf article that I found: Medical Devices in the new EU

Hope you can help me

The MDD addresses the language issue in Article 4, 4. as follows:

Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.

I interpert this to mean that each country (state) sets its individual requirement for language. I use the article you linked to as a guide, but I always verify it with the competent body of the country. I Check the competent body's web site for the official information.

BTW, welcome to The Cove.

 

[Hultermans]

Thanks Al!

So I think we've got some translating to do then...
Or is this document not interpreted that strictly and is English most often accepted as well?

Mind you that it's only the labeling I am talking about, so basically the question is whether we have to translate for example the following on our labels:
-Order number
-Designation
-Storage conditions
-Made in The Netherlands
-Packed by
-Etc...

 

[Al Rosen]

Thanks Al!

So I think we've got some translating to do then...
Or is this document not interpreted that strictly and is English most often accepted as well?

Mind you that it's only the labeling I am talking about, so basically the question is whether we have to translate for example the following on our labels:
-Order number
-Designation
-Storage conditions
-Made in The Netherlands
-Packed by
-Etc...

Everything required in Annex I 13. Some countries will make an exception if it is a professional device and you have an agreement from your customer.

 

[Hello - 2006]

Thanks Al!

So I think we've got some translating to do then...
Or is this document not interpreted that strictly and is English most often accepted as well?

Mind you that it's only the labeling I am talking about, so basically the question is whether we have to translate for example the following on our labels:
-Order number
-Designation
-Storage conditions
-Made in The Netherlands
-Packed by
-Etc...

I think we can follow EN 980:2003 - Graphical symbols for use in the labelling of medical devices, it will help us to eliminate the unnecessary translating procedures.

 

[Hultermans]

The EN 980:2003 is clear on symbols and how to use them, no question about that.

But it's another thing when it comes to label components that are company specific, especially when the components contain (english) words

 

[wrodnigg]

It is an idea to use symbols for labeling. So you can use one product together with instructions in different languages. You can also create your own symbols (for additional information), als song as you explain them in the instructions.

Labeling and Instructions have to be issued in the official language of the member state you want to sell the device. For labeling the only thing you would have tro translate is the description/intended purpose.

But you have to translate the instructions to the national language. For devices for professional use the instruction can be in english in most memberstates.

~ghw

 

[Al Rosen]

What are the Labeling & Instruction's Language Requirements for Germany?

For devices for professional use the instruction can be in english in most memberstates.

~ghw

What about Germany? This is what I have as guidance(complete document attached):

Medical devices may be only supplied to users, if the information intended for such persons is in the German language. In justified cases another language which is easily understood by the users of a medical device can be envisaged or provisions have to be made to ensure that the user is informed by other means. However, in such case, the safety related information must be in German or in the language of the user (§11 section 2 MPG). Professional technical information for qualified personnel and instruction in the correct handling of the medical devices in Germany is only permitted via a sufficiently qualified medical devices consultant (§ 31 MPG).

§ 31
Medical devices consultant
(1) Any person who provides technical information to experts or instructs them in the proper handling of medical devices on a professional basis (medical devices consultant), may only carry out such an activity if he/she possess, for the specific medical device, the requisite expert knowledge as well as the experience needed to provide information and, where necessary,
instruction in the handling of specific medical devices. The first sentence shall also applyto information given by telephone.
(2) The following shall be deemed to have the necessary expert knowledge:
1. any person who has successfully completed a course of studies in a natural science, medical or a technical profession and has received training on specific medical devices,
or
2. any person who, for a period of at least one year, in justified cases also for a shorter period of time, has gained the necessary experience in informing and, where necessary, instructing others in the handling of specific medical devices.
(3) The medical devices consultant shall furnish the competent authority, upon request, with proof of his/her expert knowledge. The medical devices consultant shall have up-to-date knowledge of the specific medical devices so as to be able to provide competent advice. The sponsor shall ensure that the medical devices consultant receives regular training.
(4) The medical devices consultant shall take written record of reports from experts bearing on adverse effects, interactions, malfunctions, technical defects, contra-indications, falsifications or other risks associated with medical devices and transmit them in writing without delay to the person responsible according to § 5, sentences 1 and 2 or that person's
safety officer for medical devices.

I've attached the complete document to this post.Do you know:

1. what a qualified medical devices consultant is?
2. where I can find someone qualified for Magnetic Resonance Imaging scanners?

In the US we have what are called MRI physicists.

 

[PAMELAGR]

There is no final published rule that we are aware of this far. Much of the
work in this area is being performed by a Brussels Organization called:
EDMA, European Diagnostic Manufacturers Association. You an find them here:
www.edma-ivd.be

 

[wrodnigg]

Hello Al,

What about Germany? This is what I have as guidance(complete document attached):I've attached the complete document to this post.Do you know:

1. what a qualified medical devices consultant is?
2. where I can find someone qualified for Magnetic Resonance Imaging scanners?

In the US we have what are called MRI physicists.

I know, therefore I wrote _most_ and not all...

In Germany and Austria as well, German is the required language.
(I have the relevant laws in german, so it's easier for me to read

The german law also says (§11(2)) that under certain exceptions an other language than german is acceptable, if ... [you already posted the phrase]

The wording "qualified medical devices consultant" is a little bit misleading.
§31 (and similar in the Austrian Medical Device Law) statest, that sales representatives of the MD manufacturer has to have graduation/qualification defined in §31 and has to be trained on medical devices before they are allowed to work as "medical devices sales rep" (which would be the clearer phrasing).

And you will find one at each manufacturer of Magnetic Resonance Imaging scanners in Germany