             
 |
|
Rules - IVDD The Transition PeriodThe new rules provide for a transition period during which the manufacturers are given the opportunity to choose whether they want to market their products according to the present legislation or the new rules.The Directive on in vitro diagnostic medical devices was officially adopted on October 27, 1998, and was published in the Official Journal of the European Communities on December 7, 1998. As of June 7, 2000, manufacturers of in vitro diagnostic medical devices are in a position to have their products approved according to the new rules and thus affix the CE marking as a visible proof of conformity with the requirements of the Directive. The transition period for in vitro diagnostic medical devices expires on December 7, 2003. After this date all in vitro diagnostic medical devices that are marketed in Europe must carry the CE marking. Back to index |
|