Medical Translation Insight

The latest version of the Medical Device Directive 2007/47/EC broadened the definition of "medical device" to include software that is intended for diagnostic or therapeutic purposes. This means many medical device manufacturers are rushing to localize software so that their products can retain the CE Mark.

What is covered by the new definition? Just about any software and language appearing in a user interface, including those for tiny devices. If the device is intended for really high-end professional use, manufacturers might be able to convince a national competent authority that English software is acceptable but this argument does not usually work.

For medical device companies that are thinking about being "flexible" in their approach to the new requirements, Jaap Laufer of the Emergo Group gives the following advice: Do so at your own risk.

In his recent audio conference Industry Update: EU Labeling for Medical Devices he gave the following case study:

A few years ago, a device company released an automatic defibrillator. In the tradition of whistleblowers everywhere, one of the company's competitors called the authority and said, "Look, in this and this case something went wrong with the use of this product. And it went wrong because the display was not in the national language."

As it happened, the device was contained symbols but the symbols were not explained in the instruction for use. But even if it had been, under these circumstances, under emergency circumstances, obviously the national language should have been displayed on the LCD screen and prompted the lay user to perform a certain action, which he failed to do. And as a result, a patient had to be hospitalized and it was alleged, died a week later. Whether that was true or not is not relevant. It prompted the national competent authority into great action, and it almost killed the company.

So, device manufacturers beware: Localization requirements are not to be taken lightly. If you want to avoid translating the user interface of a device, you better have a very good reason or, even better, a formal exemption.


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