Dear Melissa,
Translating labeling for medical devices designed for lay users is a given and effectively non-negotiable. In the case of medical devices for professional use only, however, a certain degree of latitude exists in the EU for medical device manufacturers.
The majority of EU member states require medical device labeling to be in their official language regardless of whether the device is intended for layman use or professional use. However, some member states will accept labeling provided in English as long as the device is for professional use only.
In practice, many manufacturers choose to translate labeling for all EU countries in which they market their medical devices for professional use, regardless whether this is actually a requirement or not, despite the additional costs. It is another way of minimizing the potential risks associated with using their products and so a sound risk-reduction measure. It is also a strong marketing tool.
You may find more info in this article, which includes results of the research that CROMSOURCE conducted among individual competent authorities of each of the EU member states:
http://www.moravia.com/en/knowledge-center/life-sciences/language-requirements-for-eu-medical-device-labels/ This article describes the current situation, but new EU Medical Device Regulation is already in the making, and will replace the current Directives. I don't expect the Regulation will radically change the requirements for translation of labels.
A few things to keep in mind:
EU Directive (the current setup)
...is a legislative act of the European Union, which requires member states to achieve a particular result without dictating the means of achieving that result. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted.
EU Regulation
...is a legislative act of the European Union that becomes immediately enforceable as law in all member states simultaneously.
The current proposals for the Regulation on medical devices,and the Regulation on in vitro diagnostic medical devices, have this to say as regards languages and translation:
Annex II, Technical Documentation (both regulations)
INFORMATION SUPPLIED BY THE MANUFACTURER
(a) a complete set of
the label(s) on the device and on its packaging;
the instructions for use;
(b) a list of the language variants for the Member States where the device is envisaged to be marketed.
Article 8, par 7 (both Regulations)
Manufacturers shall ensure that the device is accompanied by the information to be supplied in accordance with Section 17 [Section 17 for IVD, Section 19 for MD] of Annex I in an official Union language which can be easily understood by the intended user [or patient, for MD]. The language(s) of the information to be supplied by the manufacturer may be determined by the law of the Member State where the device is made available to the user [or patient, for MD].
[For IVD also]
For devices for self-testing or near-patient-testing, the information supplied in accordance with Section 17 of Annex I shall be provided in the language(s) of the Member State where the device reaches its intended user.
Article 15, par 1 (Article 17, par 1 in Medical Device Regulation)
The minimum content of the EU declaration of conformity is set out in Annex III. It shall be translated into the official Union language or languages required by the Member State(s) in which the device is made available.
Kind regards,
-------------------------------------------
Libor Safar
Moravia Life Sciences
Brno
Czech Republic
-------------------------------------------
Original Message:
Sent: 02-24-2014 05:35
From: Alberto Poli
Subject: Labeling for EU and other countries
Dear Melissa,
I can tell you that in China you need labels and IFU in chinese and should be submitted to SFDA. In Japan you need a translated IFU that comply with a specific format. You can find the specific regulation for japanese IFU searching for YAKUSHOKUHATSU No. 0310003
and
YAKUSHOKUANHATSU No. 0310001
if you have problem finding the translated documents and you need them let me know.
hope this helps you
Alberto
-------------------------------------------
Alberto Poli
Regulatory Affairs Manager
Brescia
Italy
-------------------------------------------
Original Message:
Sent: 02-24-2014 03:18
From: Lee Seaman
Subject: Labeling for EU and other countries
Dear Melissa,
You ask about "Asia as well."
I specialize in the translation of Japanese-language regulatory materials; if you are planning on selling in Japan, I am almost 100% certain that you will need labels in Japanese (or at least a stick-on translation into Japanese).
-------------------------------------------
Lee Seaman
President
Seaman Medical, Inc.
Medical and Pharmaceutical Translation from Japanese to English
Bellingham WA
United States
-------------------------------------------
Original Message:
Sent: 02-23-2014 01:20
From: Marco Catanossi
Subject: Labeling for EU and other countries
Dear Melissa,
In EU there are 24 official languages and three "procedural" languages (French, English and German) for European institutions' bureaucratic purposes.
At art. 4 , point 4, the Medical Device Directive states that is up to each country, when the Directive is transposed into local enforced legislation, to specify if the label and instruction for use must be in his local language or not.
For the main countries (Italy, Germany, France, and so on) I'm sure it is mandatory their national language, but for minor countries you should check case by case.
Be very careful to respect those language requirements in EU, because not complying can cause the shipment to be blocked at custom, or, once in the market, corrective field action or even recalls.
Hope to help.
-------------------------------------------
Marco Catanossi MS
Ing. Marco Catanossi - VAT Nr. IT02996670549
Foligno
Italy
-------------------------------------------
Original Message:
Sent: 02-22-2014 03:39
From: Melissa Basnight
Subject: Labeling for EU and other countries
We sell all over the world and we create our own labels as well as labels for customers.
For most of our products we have the six European languages on the label. Is this a requirement to have all these languages on the label? Do we need more languages since we sell to Asia as well? We translate our IFU into 26 languages currently.
-------------------------------------------
Melissa Basnight RAC
Zest Anchors
Escondido CA
United States
-------------------------------------------