Hidden Cost of a Distributor Acting as Your EU MDR or IVDR Importer

As you know by now, Article 13 of the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) defines the specific obligations of a “new” Economic Operator in addition to the Legal Manufacturer, Authorized Representative and Distributor: the Importer. To be clear, the role of importer is not new. In fact, it’s mentioned more than 100 times in the most recent edition of the Blue Guide, published well before the MDR and IVDR. Article 13 stipulates what the Importer is expected to do. It’s not optional. If you don’t have a legal entity in Europe, it needs to be clear who operates as your importer.

The importer has similar responsibilities to your European Authorized Representative. The importer’s primary role is to verify your compliance with the MDR and IVDR. You can think of your EU importer as “another set of eyes” ensuring your compliance (what EU importers do) with strict new EU MDR and IVDR requirements and playing an active role in the Manufacturers PMS and traceability of their devices placed in Europe.

Device and IVD manufacturers with a legal corporate entity in a European Union member state can act as the importer. Whether to hire an independent third party or ask a friendly distributor or logistics company to take on this role is a common question for all other manufacturers.

On paper asking one or more of your distributors to be your EU importer seems like the simple solution. However, here’s a key issue many manufacturers overlook: labeling. Article 13 requires that the name of your EU importer be clearly identified.

“Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trademark, their registered place of business and the address at which they can be contacted, so that their location can be established.”

This presents a quandary for manufacturers. You are already required to put your European Authorized Representative (EAR) on your device labeling. Because most manufacturers typically only have one representative, this works fine for most small to midsize device manufacturers. One Authorized Representative = one label in Europe. Nice and easy.

Multiple distributors as importers = multiple headaches

Most medical device and IVD manufacturers, however, have multiple distributors serving different countries and regions in Europe. For instance, let’s say you have distributors in Germany, France, Italy and Spain. You could ask your German distributor to be your EU importer but their name would appear prominently on all devices you distribute in Italy, Spain, France and other European countries. How do you think your French distributor will react when they see your German distributor name on devices shipped to France? Do you think that they will continue to be motivated to sell your device over a competitor? Hmmmm.

True, you could appoint several EU distributors as importers but in doing so you’ll create a new headache: creating separate sets of device labels for each product and market. That cost can add up quickly. You also need to manage and ensure that your EU distributors can act on their obligations as importer at all times. This is necessary to avoid MDR non compliance issues with regard to PMS and device traceability. Managing numerous distributors who also act as your importer can become very challenging.

If two years from now you are unhappy with your Italian distributor but they are also your importer listed on your labeling, what will you do? Ouch. ​Changing distributors that are also importers means all new labeling and the headache associated with products already on the market with their name on the label.

Maintain your independence with the new EU MDR and IVDR

Appointing a distributor as your EU importer seems like the easiest short-term solution. If you have been working with one trusted distributor in Europe for many years, it may make sense. Before you reach out to a distributor to ask if they will take on this role, consider the value of maintaining your company’s independence and think about the long-term impact of your decision. If you appoint an independent EU importer you’ll have one label that works for all devices shipped to any European country. You can change distributors at any time without impacting labeling. You can also avoid confusion among customers and hard feelings among your distributors. Having an EU importer will also allow you to better manage MDR compliance throughout your supply chain.

Learn more

• • How the EU importer process works

  • Frequently asked questions