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. 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.”
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.
Think about 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.
The intent of Article 13 is that your selected Importer is identified and can be contacted all the way through to the end user. If there is room, you should consider placing the name and address of your importer next to your European Authorized Representative. This option imay only be practical if you have one importer or all European markets, or you already have device labeling specific to certain geographic markets. ISO 15223-1 includes a symbol (shown below) for the importer that should be used.
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:
The following company is acting as Importer for this product on behalf of Generic Medical Devices Inc. in compliance with Article 13 of the EU Medical Device Regulation (2017/745) and/or In Vitro Diagnostic Regulation (2017/746):
Prinses Margrietplantsoen 33
2595 AM The Hague The Netherlands
Adding a generic email address is not required but is recommended. Your importer should have one for this purpose.
That being said, remember that the intent of Article 13 is to make sure the Importer can be identified easily. If you place a single insert inside a multi-pack box of devices you are not really following the intent of Article 13. More guidance on what's allowable is likely to emerge.
How to avoid conflicts associated with listing your importer
Most medical device companies work with a variety of distributors in various European countries. While you can appoint a distributor as your importer there are many reasons not to do so. Using distributors as your importer may seem like an easy solution but it can create unanticipated labeling challenges and confusion among your distributors. A better solution is to hire an independent third-party such as MedEnvoy Global to act as your importer for all devices in all European countries. Distributors are not regulatory experts and because the importer can be held financially liable for non-compliance of your device with the MDR and IVDR, you want someone on your team who knows the regulatory requirements inside and out.