What is an Importer under MDR 2017/745?
Importer
Any natural or legal person established within the Union that places a device from a third country on the Union marketWhat is a Distributor under MDR 2017/745?
Distributor
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 into serviceResponsibilities of the Importer
- Shall only place devices that conform to MDR on the market
- Verify that the device is CE marked
- Verify that a Declaration of Conformity is available
- Verify that a manufacturer is identified
- Verify that an authorised representative has been designated by the manufacturer
- Verify that the device has all required labelling as per MDR requirements
- Verify that a UDI has been assigned by the manufacturer where applicable
- Place their name, registered trade name, mark , registered place of business and address details on the associated packaging or in documentation which accompanies the product
- Shall ensure all storage and transport conditions comply with the general safety and performance requirements set forth in Annex I and by the associated manufacturer
- Shall maintain a register of complaints , non-conforming devices, recalls and withdrawals
- Shall inform manufacturer or its authorised representative if there is any doubt that the device placed on the market does not comply with MDR
- Shall liaise with the manufacturer, authorised representative and importer/distributor (where applicable) regarding complaints, non-conforming devices, recalls and withdrawals
- Shall retain a copy of the EU DoC and a copy of any relevant certificate where applicable
- Shall co-operate with any competent authority request
Responsibilities of the Distributor
- Verify that the device has been CE marked
- Verify that the EU Declaration of Conformity is available
- Verify that the device has all information provided by the manufacturer
- Where imported devices are concerned, verify that the importer has complied with Article 13 (General Obligations of importers)
- Verify that a UDI has been assigned by the manufacturer where applicable
- Shall ensure all storage and transport conditions comply with the general safety and performance requirements set forth in Annex I and by the associated manufacturer
- Shall communicate complaints, or reports from healthcare professionals, patients or users about suspected incidents pertaining to a device they have made available to the manufacturer and where applicable the manufacturers authorised representative and the importer.
- Shall maintain a record of all complaints, non-conforming devices, recalls and withdrawals
- Shall keep the manufacturer, the authorised representative informed of all progress associated with complaints, non-conforming devices, recalls and withdrawals and provide them with any information upon request.
- Shall co-operate with any competent authority request