CE Marking
EU Foreign Language Labeling Requirements
There are two major areas of confusion about the translation requirements when CE marking a product for export to the EU
States. One is that everyone talks about "CE Marking translation requirements" without actually reading the specific Directive(s) that apply to their products. Two, when they do read them they are vague and inconsistent. Whether people read the directives or
not the top ten areas of confusion (and the correct explanation) are listed below:
#1 We only need to translate those portions of our materials that relate to safety, correct?
Yes, providing your products fall under the Machinery Directive.
#2 We are writing into our agreements that our distributor, agent, or end-user is responsible for these translations, does this take us off the hook?
Transferring the translation responsibility to someone else is your decision to make, but any liability stemming from these translations remains the responsibility of the manufacturer.
#3 We only use the five primary European languages, does that cover it?
If you are only selling in EU States that require these "primary" languages you are O.K.
#4 We don't know which languages are spoken in which countries and cannot possibly be held responsible.
Sorry, not an acceptable excuse.
#5 Please, everybody speaks and reads English over there, do you know how much translations cost?
An unacceptable defense when someone gets hurt because they cannot read the instructions
#6 The Medical Device Directive 93/42/EEC article 4.4 states: 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. The In-Vitro Diagnostic Directive 98/79/EC article 4.4 states: "Member States may require the information to be supplied in their official language when a device reaches the final user."
All Member States and future Member States wrote very specific, legally enforceable, national language requirements when they adopted the Medical Device and In-Vitro Diagnostic Directives into National Law.
#7 Our Medical Devices are handled or used by professionals only and we heard that these types of devices are exempt from translation requirements. We have therefore added the statement " FOR PROFESSIONAL USE ONLY" to all our English materials and continue to use them.
The Medical Device Directive requires than one must make separate application to each EU State's Competent Authority and make a convincing case to be granted this professional exemption. Very few have been granted so far. It is a time consuming and expensive process.
The In-Vitro Diagnostic Directive allows some exceptions by very few countries. They have been listed below.
#8 Our Notified Body said that they are only responsible for checking our translation procedure. They never checked if we had the correct language(s) for each country, so we must be O.K.
The Notified Body expects you to follow your own translation procedure, which should include adherence to the National laws of each EU State to which you export.
#9 One of our European distributors sold product outside their assigned territory which happens to use a different language. Thank goodness we are not responsible for languages once the product is out of our hands.
The manufacturer retains liability throughout the lifespan of the product, machine or device.
#10 We figure that our chances of getting caught are about the same as a camel crawling through the eye of a needle.
Enforcement is not only performed by Customs Officials, it can also be triggered by a complaint filed by one of your competitors or unhappy customers, random checks by government inspectors, or accident investigations. Translations have also become a checklist priority by the Competent Authorities.
In our role as Authorized Representative for manufacturers of Medical devices and In-Vitro Diagnostic devices and machinery, we attend conferences, scan reports and industry newsletters and interact with the Competent Authorities. Based on what we learned we compiled the following update for devices that fall EXCLUSIVELY under the Medical Device
Directive (MDD 93/42/EEC) and the In-Vitro Diagnostic Device Directive (IVD 98/79/EC). Central and Eastern European Countries joining the EU are transposing these two directives into their National Law and have been bolded on the list below:
FOREIGN LANGUAGE REQUIREMENTS FOR LABELS AND INSTRUCTIONS FOR USE IN ACCORDANCE WITH THE MEDICAL DEVICE AND IN-VITRO DIAGNOSTIC DIRECTIVES
ENFORCEMENT: Enforcement efforts include a review program for Risk CLass I medical and low Risk In-Vitro Diagnostic Devices that may affect 10% of all technical files per year. For medical and In-Vitro Diagnostic devices manufactured outside the EU, the Competent Authorities contact the European Authorized Representative as shown on the device
label (required). Copies of the translated materials to be presented at their
office within 2-3 days.
Be aware that incorrect labeling, packaging and instructions for use may lead to regulatory,
criminal or product/civil liability in the EU. Closely monitor your product's translation requirements
and look for innovative ways to the keep the cost to a minimum.
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