The European Union is set to expand again, this time primarily in south-eastern Europe.
The countries of the Balkan peninsula, having met the requirements for EU inclusion, have applied for EU membership with Croatia and Macedonia getting first priority and Albania, Montenegro, Serbia, Bosnia, and Kosovo close behind. Turkey has already applies as well.
Iceland has applied and, until recently, was considered a shoe-in for membership. However, fall-out from the financial crisis has soured both Icelanders and certain EU member states on membership.
What does this mean for medical device companies? The 2010 Medical Device Directive is placing higher scrutiny on the risks in labeling and software, and it requires translation into the languages for which the device is intended. So if you are planning to sell products in any of the Balkan countries, be prepared to translate into yet more languages...
Want to get a head start? Take a peek at our primer on the languages of the former Yugoslavia.
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