Home » Resources & News » Does an EU Medical Device Importer Take Physical Possession?
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.
Medical Device importers DO NOT take physical possession
When you hear the word “importer”, you might assume they’re involved in the physical handling of your medical device during importation. That would make sense but if true it would also completely change how the importation process works. It would slow it down and create addition costs. We are pleased to inform you that your importer is NOT required to handle or inspect your devices. Here’s why.
Additional responsibilities of a Medical Device Importer
The primary role of the importer is to verify your compliance with the MDR or IVDR, not physically inspect your devices (medical devices or IVDs). 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. The importer can also 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).
Ensure your compliance with the EU MDR or IVDR
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 to delay your shipments to distributors. If you find a distributor or some other entity willing to act as your importer, you want to be sure that they have efficient processes in place. If they are ISO 13485 certified, that’s even better. Otherwise, it WILL cost you money and headaches in your EU supply chain.
EU MDR and IVDR compliance without handling your products with MedEnvoy
To avoid delays, as your importer, MedEnvoy has an online portal for manufacturers which allows clients to upload shipment and medical device information plus relevant documents. An alert is immediately sent to an MDR or IVDR specialist on our team who quickly reviews and approves your information. It’s all online. At MedEnvoy we keep your Declarations of Conformity, labeling, and certificates on file for quick reference.
Learn more about MedEnvoy’s Medical Device Importer service
