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IVD Directive must cover all control products

This article was originally published in Clinica

Executive Summary

The IVD-Medical Devices Directive should cover all control materials, irrespective of whether they are used in medical laboratories, according to ECOSOC in its opinion on the draft Commission Directive. It is "absolutely unacceptable" for control materials for external quality assurance to be expressly excluded, the European consultative body argues.

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