No doubt you landed here because you did some research and figured out that you now need an EU-based importer. Perhaps you have been exporting medical devices to Europe for many years and are wondering if your distributor(s) can also fulfill the role of importer for you.
Let's clarify one thing straight away. "Importing" can involve three different processes:
Physical handling and movement of devices
Placing the device on the market
Before we address the importer role we should say that the need for an importer is not new. Section 3.3 of the Blue Guide has defined the importer role for many years. What’s new is that Article 13 of the European Medical Device Regulation now expressly requires an importer with specific obligations for any medical devices being imported into the European Union (EU).
Will your distributor want to act as your importer? Maybe not
So, back to your question. The answer is “yes” – your EU distributor(s) can technically act as your importer. You can also have multiple importers in, for example, different countries. But there are several considerations to make before you ask a distributor to act as your EU importer.
1. You should not assume that your distributor will want to serve as your importer. While the importer is primarily a “behind the scenes” operator, they have many responsibilities as the entity responsible for placing your devices on the market and are financially liable if non-compliant devices are placed on the EU market. Distributors are not.
2. The fines levied by each EU country can be significant if these obligations are not correctly followed, particularly if these have led to non-compliance with the MDR. Distributors may not be up to the task of fulfilling those obligations.
3. Because the responsibilities of the importer and their associated liability are significant, they will need to have access to and carefully examine your technical documentation to ensure compliance with the MDR. Sharing technical documentation with your distributor as your importer is perhaps not something you would like to do.
4. Your selected importer needs to be clearly identified up to the point where the device is "put into service." in practical terms this means all the way to the end user. When you have multiple distributors, having one of them identified as the importer may not be commercially acceptable by your other distributors.
There’s another option...
Selecting an “independent” importer that is solely focused on executing on its importer obligations and that will ensure MDR compliance without a need to take physical possession of your devices, is an option MedEnvoy Global offers to non-EU based manufacturers as an alternative to selecting a distributor(s) as your importer. In addition, if you do have an EU based legal entity, but do not have the resources or structure to fulfill the MDR obligations of the importer, MedEnvoy Global can perform all of the “back office” responsibilities of the importer while still allowing you to act as the official importer. This means your name (as importer) will appear on device labeling/packaging/IFU, as required by the MDR and IVDR, but MedEnvoy will conduct the tasks of the MDR importer on your behalf.