This article was originally published in The Gray Sheet
Directive 98/79/EEC of the European Parliament and Council of October 27, 1998 on in vitro diagnostic medical devices, which went into effect on December 7, 1998, is required to be incorporated into member states' national legislation by December 7, 1999. This step will be accomplished in Germany by a "Second Amendment to the Medical Device Act," according to German device industry group BVMed's 1998 annual report, available on the Internet at http://www.bvmed.de/#English. By June 7, 2000, manufacturers marketing IVDs in Europe must be in a position to label their products with the CE mark. A transitional period allowing application of the Medical-Technical Equipment Ordinance in lieu of the CE mark will expire on Dec. 7, 2003
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