The European Union is set to expand again. 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. What does this mean for medical device companies?
The 2010 Medical Device Directive is placing higher scrutiny on the risks in labelling and software and requiring translation into the languages for which the device is intended. So if you're planning to sell products in any of the Balkan countries, be prepared to translate into some new languages.