Francesco Dati
The New European Directive on in vitro Diagnostics
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. Clin Chem Lab Med 2003; 41(10):
12891298
Clinical Chemical Laboratory Medicine, Walter de Gruyter
Print ISSN: 1434-6621
Volume: 41, 09/2003
Pages: 1289 - 1298
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