Clin Chem Lab Med
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The Directive on in vitro Diagnostic Medical Devices (IVDD 98/79/EC) was officially adopted by the European Union (EU) on December 7, 1998. The IVDD aims to supplement the legal framework of the European Community, which governs the conditions for the placing on the market of medical devices, by extending the already implemented legislation to the category of in vitro diagnostic medical devices (IVDs). They consist of those devices, including reagents and reagent products, calibrator materials or instruments, as well as specimen receptacles, intended by the manufacturer for the in vitro analysis of specimens derived from the human body. ⋯ In the meantime, the IVD directive has been transposed into national law in all EU countries. During a transitional period ending in December 2003, manufacturers will have the option of following pre-existing national regulatory processes or taking their IVDs through the new procedures as specified in the directive. Following this, starting from 7th December 2003, adherence to the directive regulations will become mandatory, and only IVDs bearing the "Communautés Européennes (CE) mark" can then be sold in the EU.