Many companies tend to see translation of instructions for use (IFU) as an unnecessary cost as well as something of less importance. In this article I will show why it is necessary and important, and I will also give some advice on cost savings.
If you have a medical device and want to put your product on the market within the European Union (EU), you definitely have to translate into all of the official EU languages. The reason is that by definition the IFU is a part of the product. If you try to deliver without a translated manual, then your product is not complete and may not be accepted.
Looking at the strictly legal aspects of the translation issue, the question is “What can happen if a product is placed on the market without IFU in the national language?” Here is just one example from Sweden. This is similar in many other countries: “In accordance with the Medical Devices Act (1993:584) fine and imprisonment of max 1 year can be imposed for contravention of the requirements and conditions for placing products on the market.” Legislation in many other countries such as Russia, China and Taiwan is the same — that is, the IFU has to be translated to the national language.
A global task force is presently working on harmonizing the different rules to simplify the process. Today, applying the rules stated in the Medical Device Directive (MDD) in Europe does not necessarily mean that this is accepted in countries outside the EU.
Once we have accepted the fact that we need to translate, then comes the next question: What do we have to translate? The MDD, Annex 1, section 13 states that IFU should be a document “. . . describing for the user the safe use of a medical device for the purposes designated by the manufacturer.” Then it can be asked, “What is ‘safe use’?” How much information is necessary to use the equipment in a safe way?
Some guidance can be achieved by looking more closely at the text in the MDD:
- (a) Each device must be accompanied by the information needed to use it safely. . . .
- (d) Instructions for use must be included in the packaging for each device. . . .
- (i) any special storage and/or handling conditions
- (j) any special operating instructions
- (k) any warnings and/or precautions to take
The generally accepted interpretation of this is that all safety instructions must always be in the national language of the user. So, who is the user? For medical devices it could be argued that the users are professionals, indicating that there is less need for instructions. The question then becomes “Is there a difference between professional and other users?” Looking at legal texts in different countries a statement equivalent with or similar to the following is found: “. . . language for information for user and the patient in accordance with Annex I of Directive 93/42/EEC, point 13, when the device reaches the final user, regardless of whether it is for professional or other use.” Obviously, we need to translate the IFU even if the end user is a highly educated university professor.
My personal view of this is that to a certain extent it has to do with national identity, that is, “Why should I have to read English instructions when my mother tongue is what I use all the time?” Some countries have very strong feelings about this, and they want to state that their languages are as good and valid as English.
From a commercial standpoint, it could be a strong competitive argument that you can provide an IFU in the mother tongue of the user. Doing this may very well improve the image of your company and make the potential buyer more positive toward your product. So what can we do to meet the requirements and at the same time make the translation as smooth and cost efficient as possible?
First of all, we need to have well-defined processes for the translations as well as the quality assurance of the translations. A legal text states, “As a part of the quality system . . . the manufacturer should have procedures for ensuring accurate translation of e.g., labelling, instructions for use and product claims in marketing material.” “These are especially important for user instructions where the safety and claimed performance of the device may be compromised through inadequate translation” (Ref:NB-MED/2.5.2 /Rev 3).
For cost-efficient production the key is to invest in an XML-based content management system (CMS). In our company we have recently implemented a CMS, and we can already see savings in time and money. Some companies have shown savings of up to 80% when they have gone from traditional publishing to XML.
With a good CMS you can export an XML file to your translation vendor and get the corresponding translation back as a new XML. With a click of the mouse you import the translation, and, if you have done your homework properly, that is, created correct stylesheets, the layout of a few hundred pages is done in a few minutes.
Make sure your CMS has a good system for version handling and change records. This is extremely important if you have products with frequent releases. In a CMS you will reuse big chunks of already approved texts, thereby minimizing the review time as well as the number of words you send for translation for each new release. To cut costs you should also look into the quality of the source text, try to make the source as short and consistent as possible and make sure your tech writers understand the importance of writing translatable texts. I will come back to this in another article where I will look into tools and methods for authoring. M
Göran Nordlund is project manager, User Information & Education, at MAQUET Critical Care AB in Solna, Sweden. Questions or comments? E-mail firstname.lastname@example.org
This article reprinted from #78 Volume 17 Issue 2 of MultiLingual published by MultiLingual Computing, Inc., 319 North First Ave., Sandpoint, Idaho, USA, 208-263-8178, Fax: 208-263-6310. Subscribe