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Amendment of EU Directive no. 93/42/EEC

21. 01. 2008

On 21 September, 2007, the Official Journal of EU published the Directive no. 2007/47/EC of 5 September, 2007. The said Directive has amended, among others, the Directive no. 93/42/EEC on medical devices which has thus been changed and amended substantially. This is the greatest change so far for the period of the Directive effect. It will impact all medical devices. For example, a great number of sterilizers and disinfectants will be classified in class II b. This change will come into effect after its implementation in the legislative systems of the individual member states.