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in vitro diagnostic directive

directive 98/79/EC - of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices - official journal L 331, 07/12/1998 p. 0001 - 0037

In Vitro Diagnostic DirectiveIVDD
Conducting business within the European Union has become more complicated for manufacturers of in vitro diagnostic devices. As of December 7, 2003 all products must bear CE marks (Conformit Europe) according to the In Vitro Diagnostic Directive 98/79/EC.

Click here for the full text of the IVDD.

The IVDD mandates that all product packaging, labels and documentation be in the local language of the destination country in order to obtain CE marking. Without CE marking a product will be blocked. Therefore, a major part of compliance with this directive is language translation.


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