Rene van de Zande04.05.06
Lost in Translation?
Rene van de Zande |
In general, the question we hear most goes something like this: “Do I really need to translate my Instructions for Use/Labeling into ___ if I want to sell in ___?”
The short answer is “Yes.”
The Rules
Article 4(4) of the Medical Device Directive allows member states to “require the information, which must be made available to the user and the patient in accordance with Annex 1, 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 patient use.” The basic idea is that the user should be enabled to understand how to use your device.
As a rule of thumb, you should always use the national language unless a derogation (exemption) can be obtained from the Competent Authority of the country in question. This may be possible to obtain in a handful of European countries, but unlikely from the biggies like Germany, France and Italy. However, you better have a good story regarding why your company should be exempt from the language requirements. Affordability or limited distribution is not a valid argument. Even if you obtain a derogation, it still may not protect you against a lawsuit. Just because you see other companies doing something in a certain way does not mean that they are doing it correctly.
The Risks
Some companies are willing to take a risk and not translate their Instructions or Labels/Packaging into the required national language. This is not recommended. The risks are fourfold.
First, it is possible that the importing country will seize your products at the border after it sees you have not done the required translations. That’s unlikely, but it could happen.
Second, not doing the translations could hinder your ability to obtain or be protected by liability insurance. Few companies consider this fact.
Third, if you already have products placed on the market, you could potentially be forced to recall those products. That could get very expensive, specifically if traceability is hampered and you are required to use the press to spread the word of a recall.
Finally, if your product has the potential to injure a user, not doing a translation could result in serious injury/death to the public and expose your company to ruinous damage payments or liability lawsuits. If there is an adverse incident and someone is hurt or killed and it can be linked to a failure to understand the IFU you decided not to translate, what’s your defense? You can be sure that the prosecuting attorneys will scrutinize all information provided by the manufacturer, and your defense is always hampered if information is left in another language than the one of the user. Benevolent ignorance is not an acceptable argument in court.
If in doubt about translating certain parts of your documentation and labeling, conduct a risk assessment to determine which parts pose the most risk. If the conclusion is that some parts may not need a translation (copyright statements, general company information, etc.), you can decide whether you want to translate this information. If still in doubt, translate.
Most reported (near) incidents that occur are a result of issues stemming from the Instructions for Use or labeling that are confusing, poor/no quality translation or a lack of information.
Benefits of Clear Language
Translated documents are much like the tennis racket in the back of the closet: out of sight and out of mind. This fact underscores the need to take a good, hard look at the clarity of your English language documentation before translating. Make sure the language is plain and clear. Short sentences are better than long ones. Avoid the use of slang or esoteric words that may not translate well. Most important, make sure you freeze the English master document before performing translations and maintain a record of that English version as it was translated into French, German or any other language. If your IFUs are complex, you may want to have a procedure in place to evaluate and handle changes to other language versions.
Promotional Statements
Promotional statements are coming under more scrutiny from regulators in Europe. You should ensure, however, that any claims you make in your promotional materials do not exceed those contained with the product. The US FDA, for example, is comparing statements on company Web sites with those made in applications filed with the agency. Make sure your Web site, literature, CDs or videos do not exaggerate the claims you have made in other filings/information about your product. Someone is watching.
Use of Symbols
The Directives encourage the use of symbols as a means of promoting clear communication. There are a variety of symbols in EN 980 and ISO 15223 used to indicate Sterile Product, Date of Manufacture, Batch Code, Temperature Limits and so on. You should use these symbols whenever possible, as many are widely understood throughout the medical world.
Hiring a Translator
A lot of translation companies are in business, and each differs widely in quality and price. When hiring a translation company, price should not be your primary concern. Quality is key.
How do you gauge this? First, make sure the company specializes in medical devices, and request a list of clients. Ask specifics about the experience of its medical translation team and how long these individuals have worked for the company.
Translation companies often will say they do 100+ languages and can handle anything you throw at them. In reality, some are stronger in eastern Europe, others in Nordic languages, etc. Look for a company with strong coverage in your region, because the business will have a more established pool of subcontractors.
One final point: If you choose to have a distributor do translations for you, by all means, hire a professional translation firm to validate the translation against your original English version. Not surprisingly, additional or embellished claims sometimes mysteriously appear in the final translated version.
In summary, translate, translate, translate—and don’t cut corners. Don’t think of translations as a requirement. Rather, they are an opportunity to promote the proper use of your product and demonstrate your dedication to the European market, both while limiting your liability exposure.
If you would like to receive a PDF chart that shows the language requirements in all European countries, please e-mail me at the address below.