Do the devices that perform the in vitro test also require the CE mark?
Although all medical devices, such as lancets, sold within the European Economic Area are required to have the CE mark on their label, the in vitro diagnostics used in test kits are covered by the IVD Directive (IVDD), which was adopted by the European Council of Ministers on October 5. The IVDD was published in the official journal of the European Commission on October 27, 1998. When publication occurred, the directive became law and manufacturers could start registering their IVD products. Member states will have until December 7, 1999, to transpose the IVDD into national law. Beginning June 7, 2000, member states may start applying these provisions. IVDs that conform to current national legislation may still be marketed until 2003 and put into service for an additional two years. However, experience has shown that this time frame is often not followed. In fact, Belgium has yet to transpose the Medical Devices Directive into its national law. Although your company could meet the IVDD
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