Medical Translation Insight

The updated Medical Device Directive opens door to e-labeling or "alternative labeling". According to Jaap Laufer of Emergo Group, we have a glimpse of it coming at some point - but not anytime soon.

There are two problems that stand in the way:

1. There exists an enormous diversity of languages in Europe. And there is no dominant language - in fact, the moment this would be suggested, the smaller countries would balk.


2. Internet penetration varies greatly across Europe. Estonia and Holland have achieved almost 100% Internet penetration. On the other hand, across Greece, Portugal, and southern parts of Italy, Internet access can be sporadic. As a result, requiring the use of a computer to read device labeling is unrealistic.

Unlike the MDD, the IVDD does provide for electronic labeling but only in addition to the (authoritative) paper labeling.

For more details, check out Jaap Laufer's hot-off-the-presses audio conference on EU labeling. It contains excellent information from a a true expert in the field.

ForeignExchange Translations provides specialized translations for medical device IFUs, operating manuals, and product labels.