The obligations of distributors of medical devices

The obligations of distributors of medical devices are stated in the art. 14 of the MDR Regulation (EU) 2017/745. Distributors must:

☑️ Verify the devices and the documents provided before placing them on the market

☑️ Keep a record of non-conformities, complaints, recalls and withdrawals

☑️ Be able to trace devices placed on the market

☑️ In the event of actual or potential non-conformities, inform the manufacturer and, where appropriate, the authorized representative and importer and, if the medical devices are not yet on the market, not distribute them

☑️ Keep the competent authorities informed in case of serious risks or falsified devices

☑️ Pass on all complaints and reports to the manufacturer and, if applicable, to the authorized representative and the importer

☑️ Cooperate with the competent authorities and the manufacturer in dealing with non-conformities.