Distributor

In the EU, distributors have their own obligations, such as checking the CE marking, labeling and storage conditions and passing on complaints. A distributor who relabels or repackages can take on manufacturer obligations, and in the US the 803 definition says outright that such a person is considered a manufacturer.

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

EU MDR, Article 2(34)

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

IVDR, Article 2(27)

Distributor means any person (other than the manufacturer or importer) 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

Distributor means any person who furthers the distribution of a device from the original place of manufacture to the person who makes delivery or sale to the ultimate user, i.e., the final or multiple distributor, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.

21 CFR, 821.3

natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user Note 1 to entry: More than one distributor may be involved in the supply chain. Note 2 to entry: Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition. [SOURCE: GHTF/SG1/N055:2009, 5.3]

ISO 13485:2016, clause 3.5

natural or legal person, different from the manufacturer or importer, in the supply chain who, on their own behalf, furthers the availability of a medical device or accessory to the user Note 1 to entry: More than one distributor may be involved in the supply chain. Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors. Note 3 to entry: Distribution activities alone do not include repackaging or otherwise changing the container, wrapper, or accompanying information of the medical device or medical device package other than providing the identification of the distributor. [SOURCE: ISO 20417:2021,[15] 3.5]

ISO 15223-1:2021, clause 3.4

natural or legal person, different from the manufacturer or importer, in the supply chain who, on their own behalf, furthers the availability of a medical device or accessory (3.1) to the user Note 1 to entry: More than one distributor may be involved in the supply chain. Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors. Note 3 to entry: Distribution activities alone do not include repackaging or otherwise changing the container, wrapper, or accompanying information of the medical device or medical device package other than providing the identification of the distributor. [SOURCE: ISO 13485:2016, 3.5[7], modified — added ‘or accessory’ and Note 3 to entry.]

ISO 20417:2021, clause 3.5

The MDR and IVDR definitions are identical and cover anyone in the supply chain up to putting into service. 21 CFR 803 excludes anyone who repackages or changes the labeling and treats such a person as a manufacturer. 21 CFR 821 is written for device tracking and names final and multiple distributors.