29 European countries will accept only CE marked medical and in-vitro diagnostic devices in 2004Just recently, the European Union (EU) leaders had formally agreed to allow 10 Eastern European countries to be part of the EU. Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia will join the EU in May 2004. Currently, 19 countries already require the CE mark on medical and in-vitro diagnostic devices (this includes 15 EU countries plus Norway, Liechtenstein, Iceland and Switzerland), which brings the total to 29 European countries. It was explained that the countries ascending to the EU will be translating and adopting the CE Mark legislations (including the MDD, IVDD, and AIMD) will be ready by May 2004. With these additional countries in the EU, manufacturers now have the added benefit of targeting new markets; however they now have a more difficult task of determining which foreign languages should be placed on labels. Three more countries are looking also to join the EU - Bulgaria, Romania in 2006 and Turkey in 2007. This makes the EU a formative economic competitor with the USA. For more information on this or on the CE Mark, MDD, IVDD or AIMD, please contact mdi at info@mdiconsultants.com |