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MDD Cleared Private Labelled Devices into EU

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
Our product is MDD cleared for sale and use in the EU under MDD. Our MDD certificate expires in 2023. We currently private label this product for a partner here in the USA cleared under FDA 510(k)

This partner wants to sell our product in the EU.

My understanding is that is acceptable as long as our MDD certificate is not expired. Once it expires and MDR is required for product conformance (QMS will already be compliant with MDR) with the addition of economic operators things get more complex.

Is this general understanding correct?
 
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