Distributors

A distributor is defined as being 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 it into service.

The Regulations describe the roles and responsibilities of distributors in MDR/IVDR Article 14. (For more information see also: ‘Blue Guide’ on the implementation of EU product rules.)

Distributors should make sure, by representative sampling, that the devices they distribute are compliant with the obligations described in MDR/IVDR Article 14(2):

Distributors should verify that the devices have been CE marked, that an EU Declaration of Conformity has been drawn up, and that labels and instructions for use (MDR/IVDR Annex 1 section 23) are provided in the official languages of the Member States in which the device is made available (or in languages accepted by those Member States).

Distributors should also verify that the importer’s name is indicated on each device or in the accompanying documentation, and that the device bears a UDI.

Distributors shall ensure that storage and transport conditions, when under their responsibility, are appropriate and in line with the recommendations of the manufacturer.

If a distributor considers a device to be non-compliant with the regulations, the device shall not be made available on the market. In this case, the distributor should inform the other economic operators.

Distributors should inform the authorities if they suspect that a device has been falsified or that there is a serious risk to health.

Distributors should also keep a register of complaints, non-conforming devices, recalls and withdrawals.

Distributors shall cooperate with authorities and make available all the documentation and information they have at their disposal.

Source: "Factsheet for Authorised Representatives, Importers and Distributors of medical devices and in vitro diagnostic medical devices."