6 Obligations of the Importer & DistributorThe new MDR gives a definition of ‘Importer’ and ‘Distributor’ and outlines the obligations for each role. Importers and Distributor responsibilities under the new MDR now include the following:
- ensuring the device is CE marked and that a Declaration of Conformity is available,
- that the device is correctly labelled
- where applicable a UDI has been assigned.
- liaising with the manufacturer, authorised representative and importer/distributor (where applicable) regarding complaints, non-conforming devices, recalls and withdrawals
- notification to the Competent authorities and Notified bodies (where applicable) of devices that present a serious risk
- responsibilities regarding storage and transport conditions.