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Incomplete IVD kit under IVD Regulation

#1
We are an IVD kit manufacturing company. We have one product that is incomplete due to intellectual property issues. People who buys the kit, needs to buy another two components (as drop-ins) from other company.

¿Should this be considered an LDT in IVDR? Or ¿Could we validate and register as IVD the entire kit even we do not sell it complete?
 
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twanmul

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#2
It sounds like you're not supplying it as a kit at the moment, so your device is a stand-alone which is intended to be used in combination with other devices. You should make it clear in your design history file and any instructions provided with the device that it must be used in combination with these other devices. Other than that, you should be covered (though ensure that any higher classifications the other device don't confer a higher classification onto your device).
 
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