Where Do You Need to Identify Your EU Importer on Medical Device Labeling?

By now you certainly know that Article 13 of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you to appoint an importer for all exports to Europe. But you may be wondering where you need to list that importer. On the label? In the IFU? On the box? The answer is yes. As an EU manufacturer, you should take your medical device labeling into consideration.

To learn more about how you can streamline your medical device to the EU market, click here.

Avoid conflicts associated with listing your importer on your EU medical device labeling and learn what you need to know for our experts in this video:

MDR Article 13 and EU Medical Device Labeling

Here’s what Article 13 says:

“Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.”

Considerations for EU Medical Device Labeling

Article 13 gives you plenty of flexibility to decide how you want to identify your importer but as with everything related to the MDR and IVDR, there are other considerations.

How your Medical Device or IVD is Distributed

If you are shipping to multiple countries in Europe, it may be tempting to add the name of your importer to your device label or outer packaging, just as you list your EU Authorized Representative. However, if you decide (and they agree) to have a distributor act as your importer, think about how that impacts your labeling.

Would you list multiple importers on your device label? Of course not. How about on the outer packaging? Well, you could but this would force you to create different outer packaging for the geographic regions covered by that importer. Maybe add all importers to your IFU? Not a great idea since you may need to reprint all of your IFUs because you appointed a new importer in one European market.

Although “document accompanying the device” may leave room for interpretation about format, for now the most practical solution is to add an insert to ride along with each device that says something like this: