Article 13 of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you to list your importer "on the device or on its packaging or in a document accompanying the device.” Although that language would seem to offer some wiggle room and allow you to stuff a single insert into a multi-pack shipment bound for Europe, that’s not the case. The expectation among regulators is the same as it is for identifying your European Authorized Representative. The importer should be clearly identified to the point of delivery to the end user. If you sell software as a medical device, see this post.
The EU Importer symbol for medical devices & IVDs
ISO 15223-1 is the international standard for medical device labeling and it was recently updated in 2020 with a host of new symbols, including one for the importer as shown below. Recommended options for identifying your importer are shown below.
When you have enough room for the importer symbol and address (recommended)
This option is preferred if you have room on the device itself. If not, you can add it to your device packaging, an insert inside each box or on the IFU. The name of your importer can be placed to the right of the symbol or below it. Although not required, we highly recommend adding your importer’s Single Registration Number (SRN) as registered in EUDAMED.
When you have very little room for the symbol and can’t fit the address
If space is tight on the product label, you can simply add the symbol and the name of the importer. However, the MDR and IVDR require contact information for the importer so you will still need to add the name and address of your importer in your IFU. This address should match the address used for the importer in EUDAMED.
If for some reason you prefer not to show the symbol, you can simply list the name, address and - as we recommend - the SRN of your importer. If you do so, you will need to add the word “importer” to the name and address so there is no confusion about the role of this entity. The downside of this approach is that you would need to translate the word “importer” into every language where you sell that device in Europe, making it an impractical solution. That’s why the international symbols exist...
MedEnvoy can act as your independent EU importer. Request a proposal.
If your importer allows it, you may add a generic email such as firstname.lastname@example.org, or a telephone number. This is NOT a regulatory requirement. Some considerations need to be made when including the email address or the telephone number of the importer. For instance, you may have a preference that inquiries concerning your devices are directed to you, your European Authorized Representative, or your distributor instead of your importer. Therefore, you need to decide which of the economic operators you would like to see include an email address and/or telephone number.