EU MDR & IVDR Importer
For Medical Device & IVD Manufacturers
Independent EU MDR or IVDR Importer Representation for Medical Device and IVD Manufacturers
At first glance, you may wonder why you need an MDR or IVDR importer for Europe. After all, you already have one or more distributors, and you have an Authorized Representative. So why is an importer needed? The reason is that Article 13 of the EU MDR and IVDR mandates that all device manufacturers selling in Europe have an importer. You can think of your importer as the EU gatekeeper - double checking that all required compliance steps have been taken including UDI, devices registration in EUDAMED and more. By working through MedEnvoy as your official EU MDR or IVDR Importer, you avoid asking a specific EU distributor to take on this responsibility and therefore maintain more independence at a minimal cost.
Tasks we perform as your official European Importer.
✓ Verify that the devices sold in EU carry the CE Mark
✓ Verify that EU declaration of conformity and technical documentation exist
✓ Verify that correct conformity assessment procedure has been performed
✓ Verify Labelling and accompanying information (IFU)
✓ Verify that Manufacturer has assigned UDI
✓ Verify that EU Importer is identifiable with name and contact details
✓ Verify that Manufacturer is identified/authorized rep has been assigned
✓ Verify that storage and transportation requirements are fulfilled
✓ Maintain a register of complaints
✓ Inform manufacturer if device provides serious risk/is not in conformity
✓ Check EUDAMED registration of all Economic Operators
✓ Report to competent authority regarding Serious Incidents / Serious Risks
✓ Cooperate with competent authorities regarding CAPA
✓ Store UDI for Class III implantable devices
✓ Check identification of devices within the supply chain
Why It Makes Sense to Keep Your EU Importer Separate from Your EU Distributors
Could you appoint your distributor as your EU Importer? Technically, yes. But here's why that may not make sense. Your distributor is focused on marketing and selling your products, not checking to make sure your labeling, IFU or Unique Device Identification (UDI) are compliant with the MDR or IVDR. Plus, keep in mind that the name, address and contact information of your EU Importer must appear on your device, its packaging or a document that rides along with the device.
If you appoint a distributor in Germany to also be your importer, what will your distributors in other European countries think about seeing the German distributor name on your labeling or documentation? For a nominal cost you appoint MedEnvoy as your EU Importer and can avoid these issues altogether. Read more about this here.
...that your devices have been correctly
registered in the EUDAMED database
...to ensure your UDI, product labeling and Instructions for Use are present
...you immediately if any product complaints are reported to us via phone, email or website
...with Competent Authorities, your Authorized Rep, and distributors if there is an issue with your device