The IVD Directive

The EU Directive on in vitro Diagnostic Medical Devices (98/79/EC), which came fully into force in Member States in December 2003, requires that all in vitro diagnostic devices carry the CE mark. The Directive explicitly covers materials transferred between laboratories as described above. Paragraph (9): ''Whereas, although internationally certified reference materials and materials used for external quality assessment schemes are not covered by this Directive, calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices.'' Manufacturers of kits for genetic tests also have to obtain CE marking for their products under this Directive. For this, they are obliged to assure the trace-ability of values ''through available reference material procedures and/or available reference materials of a higher order'' (Annex 1, Section 3). The expected rapid rise in the number of such kits on the market, and the increasing proportion likely to be designed for direct use by the public, adds urgency to the requirement for the availability of CRMs for genetic testing.

such as cultured cell lines, genetically engineered cell lines, genomic DNA (gDNA), recombinant (cloned) DNA fragments (rDNA), PCR amplified DNA, synthetic DNA (sDNA), and dried blood spots.

The parameters to be considered in selecting a reference material are as follows.

Getting Started With Dumbbells

Getting Started With Dumbbells

The use of dumbbells gives you a much more comprehensive strengthening effect because the workout engages your stabilizer muscles, in addition to the muscle you may be pin-pointing. Without all of the belts and artificial stabilizers of a machine, you also engage your core muscles, which are your body's natural stabilizers.

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