Lesson 3 – Importers

Importers (Article 13 of MDR)

  • Verify that the device has been CE marked and the EU Declaration of Conformity has been drawn up.
  • Verify a manufacturer is identified and designated an Authorized Representative.
  • Verify the device is properly labelled and accompanied by the required instruction for use.
  • Verify the manufacturer has assigned a UDI (Unique Device Identifier).
  • The importer keeps a register of complaints, of non-conforming devices, and of recalls/withdrawals, and provide the information to the manufacturer, authorized representative and distributors.
  • In case of re-labeling or change of the packaging such obligations (see Article 16 for further details) are limited to the need to have a certified Quality Management System.
  • They must have mechanism to report issues to Manufacturer.
  • Ensure that device is stored and transported within the requirements defined by the Manufacturer and Authorized Representative.