Medical Device Labeling: Country Code or Language Code?

R

Reiko Shiratori

#1
Hi all,

I've been learning a lot from the Cove, I'd like to say 'Thank you' before starting my question.:)

I'm wondering about labelling of a medical device which is exported to the EU countries.

At present, we use country codes: Germany (DE), U.K. (GB), France (FR), Spain (ES), Portugal (PT). Italy (IT), Denmark (DK), Netherlands (NL) and Sweden (SE), according to ISO 3166-1.

But we are going to export to Austria next year.

Do we have to add Austria (AT) on the labelling?
Or, is the German expression fine, without its country code (AT)?
Or, is using language codes (ISO 639-1) more convenient for future prospects?

Any feedback is welcome! Thank you in advance.
:thanx:

Reiko
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Labelling: Country Code or Language Code?

Any Medical Device wizards here who can help with this? My appreciation in advance.
 

somashekar

Staff member
Super Moderator
#3
Hi all,

I've been learning a lot from the Cove, I'd like to say 'Thank you' before starting my question.:)

I'm wondering about labelling of a medical device which is exported to the EU countries. <snip>
Can you give an example of your code usage for a better understanding.
There are language requirements to be respected based on where in EU you are placing your medical device, and if the information is to be used by the common user or professional user.
More clarity ... better responses you will get
 
L

Laura Halper

#4
Hi Reiko,
This is a good question, and I'm interested in seeing what other folks have to say as well.

My understanding is that you should use language codes, not country codes. These are not always the same. For example, you said you will have GB on the label to represent the UK. This is a country code. The language code would be EN for English.

Here is a link to the Official EU Languages and their abbreviations:
http://ec.europa.eu/education/languages/archive/languages/index_en.html

Note that the EU abbreviation for Danish language is DA, and for Swedish language is SV. (DK and SE are country codes)

All that being said, I recently went through a similar discussion with a company who was getting their first CE marking (class I non-sterile, so no Notified Body). Their distributor in Sweden felt strongly that the abbreviation should be SE and not SV, even though the "official" abbreviation is SV. So we went with SE.

As long as you have DE (German language) on the label, I do not see a need to add AT for Austria as this is a country, not a language.

What do other Covers think?

Laura
 
R

Reiko Shiratori

#5
Thank you for your replies, Somasheker and Laura,
:thanks:

The country codes appear on our product packages and instructions for use. In this case, on the package only. And the product is for professional use at the moment.

Thank you for the link, Laura.
It is clear and useful for me and my company people.:)
Also I think we should ask our distributers too.
Thank you for sharing your SE/SV experience.

I will wait a little more, other Covers' thoughts.

Reiko
 

chris1price

Trusted Information Resource
#6
Hi

In previous companies I have always used language codes.

If you look at the EU web site, documents are translated into all the EU languages. These are identified by the Language codes. (However there doesn't appear to be any consistency in whether upper or lower case is used!)

Chris
 

dzurn

Starting to get Involved
#7
For language codes, our company uses the ISO 639-1:2002 standard (two-letter codes). We use them as LOWER CASE letters. Those can be found here (use the two-letter column):

https://secure.wikimedia.org/wikipedia/en/wiki/List_of_ISO_639-1_codes

For country codes, we use ISO 3166-1:1997 using UPPER CASE letters. so for example if we had something translated into Brazilian Portuguese, we would use

[pt] [BR]

as the language and country codes. We also use the country codes when we have products with specific power cords, like for the UK: [en] [GB]

http://www.iso.ORG/iso/country_codes/iso_3166_code_lists/english_country_names_and_code_elements.htm

Darryl
 
Last edited by a moderator:
A

arnoholm

#8
Hi all,

I've been learning a lot from the Cove, I'd like to say 'Thank you' before starting my question.:)

I'm wondering about labelling of a medical device which is exported to the EU countries.

At present, we use country codes: Germany (DE), U.K. (GB), France (FR), Spain (ES), Portugal (PT). Italy (IT), Denmark (DK), Netherlands (NL) and Sweden (SE), according to ISO 3166-1.

But we are going to export to Austria next year.

Do we have to add Austria (AT) on the labelling?
Or, is the German expression fine, without its country code (AT)?
Or, is using language codes (ISO 639-1) more convenient for future prospects?

Any feedback is welcome! Thank you in advance.
:thanx:

Reiko
The country code and the language code should not be mixed up.
(1)
The EU consumer protection laws require that the EU distributors should be reachable by the end-users, via name+address, sometimes simply an address or a phone number. If there are more than one distributors within the EU, the distributors can be listed under different country code; e.g. German distributor under country code DE, whereas the Austrian distributor under country code AT.
(2)
The national laws of EU member states may also require that the labelling (i.e. Label + IFU) of certain products must be provided in the official language(s) of the target market(s), if the labelling is multilingual, each language can be referred by using the language code, e.g. German version under language code DE will serve the purpose for the EU member states: Austria, Germany, partially Luxembourg, partially Belgium, also the EFTA member states: Liechtenstein and Switzerland.
 
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