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How the European

MDR/IVDR Importation

Process Works 

Our Goal is to Create Zero Additional Work for You

When you engage MedEnvoy as your EU importer, you can rest assured that you are not creating more work for yourself. Because we are highly process oriented, we are able to ensure your ongoing compliance with the EU MDR and IVDR in a seamless manner.

We won't interfere with your distributors and we don't take physical control of your products.  Download a shareable PDF outlining the specific responsibilities of the EU MDR importer


We Verify Your Compliance with the EU MDR or IVDR in Parallel with Your Logistics Workflow


Medical Device/IVD


Physical Shipment to Europe
You coordinate your shipments as normal


EU Customs and VAT
Customs and tax paperwork processed


EU MDR or IVDR Compliance Verification
We verify before your product arrives


Distributor or End User

We don’t need to inspect your devices

We perform many tasks to ensure your ongoing compliance with the EU MDR or IVDR but thankfully handling your devices is not among them. Every service we provide is done electronically and it’s in our mutual interest that this be done as efficiently as possible. We generally review and confirm approval of all shipments to the EU within eight business hours of receipt, and even then it is not necessary for you to hold up shipments.

Three European markets, one importer

Need more details? Contact us

Contact us for a free, no obligation proposal