EU MDR & IVDR Importer
For Medical Device & IVD Manufacturers
Independent EU Regulatory Importer Representation from Europe's #1 Regulatory Importer!
Trusted by 550+ Medical Device & IVD Manufacturers Worldwide
You may wonder why you need an EU MDR/IVDR compliance importer. You already have distributors, and you may also have an Authorized Representative. The reason is that Article 13 of the EU MDR and IVDR now require you to identify the importer responsible for initially placing your devices on the European market. Your importer is not required to handle your devices but they do play a vital role in role in Post Market Surveillance (PMS), vigilance and traceability of devices. By working through MedEnvoy as your designated independent EU MDR or IVDR Importer, you entrust this role to regulatory professionals who will ensure your ongoing compliance.
Responsive. Knowledgeable. Affordable.
Some of the Tasks We Perform as Your Designated European Importer
Regardless of whether you are selling legacy devices holding existing CE certificates under the MDD/IVDD, or devices with CE under the MDR/IVDR, you’ll still require an EU importer. We don’t handle your products or slow down shipments but we do....
✓ Check EUDAMED registration of all Economic Operators
✓ Verify that devices placed on the EU market include CE Marking
✓ Verify that EU declaration of conformity and technical documentation exist
✓ Verify Instructions for Use and accompanying information with the device
✓ Verify labeling includes Manufacturer, EC-REP and Importer contact details
✓ Verify that MDR/IVDR storage and transportation requirements are fulfilled
✓ Maintain a register of complaints as required in Article 13
✓ Report serious incidents or risks to competent authority, if applicable
✓ Maintain traceability of device in the supply chain
MedEnvoy is ISO 13485:2016 certified.
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. Learn more about how the process works.
Required for MDR and MDD CE Certified Devices!
...that your devices have been registered in EUDAMED
...to ensure your UDI, product labeling and IFU are present
...you immediately if any product complaints are reported to us
..with Competent Authorities and others if a device problem arises