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E-labeling in the EU seen as disappointment, growing slowly (medical translation)
After celebrating the arrival of e-labeling in the EU, reality has set in. Medical device manufacturers have been slow to adopt electronic labeling, partially because more and more manufacturers find that their device is out of scope of the regulation.

In an interesting article, Dario Pirovano of Eucomed explains some other reasons why e-labeling is not nearly as common in Europe as in the U.S. Key among them is the reason that the original Medical Device Directive (MDD) was written 20 years ago. The MDD refers to "leaflets" and while e-labeling experiences in the U.S. and elsewhere have been positive, European member states and regulators are looking for local confirmation before "going all in".

Those local confirmations are slow in coming though because device manufacturers who are working their way through the dense regulation on electronic instructions for use of medical devices [PDF link] are finding many of their products excluded. Erik Vollebregt has done a nice job "condensing" the regulation into a flowchart (click for huge version):

Erik's blog post is worth reading. He gives good insights into the labeling plight of mHealth app developers.

But while the European introduction to e-labeling hasn't met all expectations, it is also important to remember that the regulation is only a first step. Because, after all, the advantages for e-labeling are clear. As Dario puts it in his article:
"In Europe, one problem is that if you want to gain access to a particular European market you have to use that state's official language, which could be a logistical nightmare. If you print instructions in all 23 languages, then you could have the situation where a pacemaker the size of two Euro coins might come with an instruction manual the size of a Bible."
Given those challenges, it is a question of when, not if, medical device manufacturers and regulators will fully embrace e-labeling in Europe.

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