IVD Regulations and Standards Q&A
Answered July 2nd, 2012 by Expert:
The short answer is that the is no harmonized standard which addresses this issue, a harmonized standard is a standard recognized as part of the regulatory framework as a mechanism of proving compliance with the Essential Requirements of the IVD Directive. There are very few product specific standards in the IVD area, the main product specific standard is for blood glucose meters for home use and there is also a standard for media. The performance Evaluation standard EN 13612 does reference many NCCLS/CLSI documents but these are not standards in terms of the regulation.
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