Importer

In the EU the importer has its own obligations, such as checking CE marking and documentation and adding its name to the device or packaging. In the US the duties depend on the part of 21 CFR, from registration to reporting and tracking.

‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;

EU MDR, Article 2(33)

‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;

IVDR, Article 2(26)

Importer means, for the purposes of this part, any person who imports a device into the United States.

21 CFR, 806.2

Importer means, for purposes of this part, a company or individual in the United States that is an owner, consignee, or recipient, even if not the initial owner, consignee, or recipient, of the foreign establishment's device that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or uses the device, unless the foreign establishment ships the device directly to the consumer or patient.

21 CFR, 807.3

Importer means any person who imports a device into the United States and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package. If you repackage or otherwise change the container, wrapper, or labeling, you are considered a manufacturer as defined in this section.

21 CFR, 803.3

Importer means the initial distributor of an imported device who is subject to a tracking order. “Importer” does not include anyone who only furthers the marketing, e.g., brokers, jobbers, or warehousers.

21 CFR, 821.3

natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed [SOURCE: GHTF/SG1/N055:2009, 5.4]

ISO 13485:2016, clause 3.7

natural or legal person who imports a medical device or accessory into a locale that was manufactured in another locale for the purposes of marketing [SOURCE: ISO 20417:2021,[15] 3.8]

ISO 15223-1:2021, clause 3.5

natural or legal person who imports a medical device or accessory (3.1) into a locale that was manufactured in another locale for the purposes of marketing

ISO 20417:2021, clause 3.8

The MDR and IVDR define the importer as the EU-established person who places a third-country device on the Union market. In the US, 21 CFR 806 covers anyone who imports a device, 807 covers US owners, consignees or recipients of devices from foreign establishments, 803 excludes those who repackage or relabel, and 821 means the initial distributor subject to a tracking order.