;   Medical Translation Insight: e-labeling, once seen as Holy Grail, provides new challenges - ForeignExchange Translations

e-labeling is not for everybodyWhile general medical device companies are still waiting for e-labeling, the European Commission's guidance MEDDEV 2.14/3 REV 1 "Supply of IFU and Other Information for IVD Medical Devices" opened the door for in-vitro diagnostics manufacturers with professional-use products to place their Instructions for Use (IFU) online instead of placing multilingual paper inserts inside product packaging.

Since then, IVD companies have been carefully evaluating their labeling options. While not having to print IFUs in 20+ languages represents a huge cost savings, "alternative" approaches to labeling present challenges in their own right.

The current issue of IVD Technology contains an informative article on the subject. "Making instructions for use available in Europe" discusses the the pros/cons of common labeling approaches.

Particularly interesting is this comparison of different operational, regulatory, environmental and user-related aspects (click image for larger version):

The main challenge in providing non-paper instructions is that IVD manufacturers must provide a toll-free number to the user. While some efforts are underway to standardize pan-European help and hotline numbers, setting up a single, consistent freephone number across Europe is a herculean task.

As the article notes:

Each of the 31 countries has its own telephone companies, which work within their national context. Thanks to international agreements, an international 800 number system exists, but it cannot be used in all countries. Moreover, it has to be activated in each individual country and monthly fees paid for each country.
But where there is a challenge, there is a business opportunity. Today, there exists a cottage industry around providing freephone services to IVD manufacturers.

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