Lesson 4 – Distributors

Distributors (Article 14 of MDR)

  • Verify that the device has been CE marked and the EU Declaration of Conformity has been drawn up.
  • Verify the manufacturer has assigned a UDI (Unique Device Identifier).
  • Verify the device is properly labelled and accompanied by the required instruction for use.
  • Ensure that device is stored and transported within the requirements defined by the Manufacturer.
  • Distributors that have received complaints or reports from healthcare professionals, patients or users forward the information to the manufacturer, the authorized representative, and the importer.
  • Verify that importer has met their obligation and sample product to verify that requirements have been met.
  • Verify that importer has complied with requirements.
  • Not place non-conforming product on the market and inform the Manufacturer and where appropriate the Authorized Representative and Importer for serious risk/falsified device, the Competent Authorities should also be informed.




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