The IVD Directivedefines an IVD as: “any medical device which is a reagent, reagent product, … instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens…”.
This means that the requirements of the IVD Directive are applicable to reagents and instruments (such as automatic analyzers) both independently and to their combinations. Reagents and instruments should be CE marked separately, while their combination into a 'system' should be validated by the manufacturer.
If company A is the manufacturer of a instrument and company B manufactures the reagents, if either manufacturer identifies the other manufacturer's device in the labelling as being compatible, then that manufacturer must validates the combination, ensuring that the essential requirements of the directive are met.
If an end user decides to use reagents on an automatic instrument not specifically validated to be used in combination by the manufacturer(s), the final test result will be under the sole responsibility of the user.
GEMAR can help define any specific test protocols necessary for assuring system compliance with the IVD directive - please contact us for further information.