Article 13 of the European Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR) requires you to appoint an EU importer. The importer is new to the MDR/IVDR and one of four “Economic Operators” deemed essential in the regulations. The other three roles include the Manufacturer, Authorized Representative and Distributor.
When you hear the word “importer” you might assume they are involved in the physical handling of your devices during the importation process. That’s logical but if true it would also completely change how the importation process works, slowing it down and adding cost. You’ll be pleased to know that your importer is NOT required to physically handle or inspect your devices. Here’s why.
The primary role of the importer is to verify your compliance with the MDR or IVDR, not physically inspect your devices. In addition to a wide range of responsibilities similar in scope to your Authorized Representative, your importer is also responsible to ensure that your products follow the storage and distribution requirements. You should also know that importers can be held financially liable for your compliance with the MDR and IVDR with fines imposed by EU Competent Authorities totaling hundreds of thousands of Euros. For this reason, many distributors and retailers will not act as the official importer for your devices in Europe. (There are also many other reasons why it would make sense to hire an independent importer rather than asking distributors to also fulfill this important responsibility).
How your importer ensures your compliance with the EU MDR or IVDR without handling your products
EU importers vary widely in their knowledge of the MDR/IVDR, and their technological prowess. Your chosen importer(s) should have a streamlined process that is 100% online and little extra work for you. You do not want importer approvals delaying your shipments to distributors. For example, at MedEnvoy we have an online portal for manufacturers that allows clients to upload shipment and device information plus relevant documents. Once that occurs an alert is instantly sent to an MDR or IVDR specialist on our team who reviews and approves it quickly. It's all online. Static documents such as your Declarations of Conformity, labeling and certificates are kept on file for quick reference. If you find a distributor or some other entity willing to act as your importer, you will want to be sure that they have similar efficient processes (even better if they are ISO 13485 certified) in place or it WILL cost you money and headaches in your EU supply chain.