The new European directive on in vitro diagnostics.

Abstract

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. This directive has introduced at the European level common regulatory requirements across Europe for the safety, quality and performance of in vitro diagnostics (IVDs), incorporating them into medical device legislation. It harmonizes the conformity assessment procedures to be applied by manufacturers before they place IVDs on the market. For certain products expressly specified in the directive, of which the most important are used for the evaluation of the safety of blood supply and patient testing, the manufacturer will have to take into account in their performance evaluation the so-called "Common Technical Specifications" (CTS). These are needed to establish the performance characteristics of the IVDs in evaluation and have the same status as harmonized standards. 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.