As you know by now, Article 13 of the new European 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. What IS new is that Article 13 stipulates what the Importer is expected to do. By the way, 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 MDR and IVDR requirements and playing an active role in the Manufacturers PMS and traceability of their devices placed in Europe.
For device and IVD manufacturers with a legal corporate entity in a European Union member state, that EU entity can act as the importer if desired. For all other manufacturers, a common question is whether to ask a friendly distributor or logistics company to take on this role or hire an independent third-party importer.
Creating unintentional confusion in the EU marketplace
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 the name of your EU importer to 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 and that works fine for most small to midsize device manufacturers because most manufacturers typically only have one representative. 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 is going to react when they see your German distributor name prominently displayed on your devices shipped to France? Think 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. Also managing and ensuring that your distributors can act on their obligations as importer at all times is needed to prevent that you have MDR non compliance issues with regard to PMS and device traceability. Managing numerous distributors who also act as your importer can become very challenging.
And consider this. What happens if two years from now you are unhappy with your Italian distributor but they are also your importer listed on your labeling? Ouch. Changing distributors that are also importers means all new labeling and the headache associated with products already on the market with that importer (distributor) name on the label!
Take the long view and maintain your independence in Europe
Appointing a distributor as your EU importer seems like the easiest short-term solution and if you only have one trusted distributor in Europe that you have been using 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 and you can avoid confusion among customers and hard feelings along your distributors. And it will allow you to better manage MDR compliance throughout your supply chain.