It is the responsibility of manufacturers to ensure that their products bear the CE mark. Obtaining such certification requires implementing risk analyses and complying with regulations, and proving that they have done so.
Only products that comply with EU regulations and bear the CE mark are allowed to enter the market. As such, importers must ensure that the devices they obtain from manufacturers outside the region have done the required procedures and passed the necessary certifications to ensure compliance.
MDR distributor must ensure that only medical devices that conform to all regulations are made available. To do that, they should confirm that all the manufacturers, authorized representatives, and importers implemented the required checks and balances and provided the corresponding documentation. As well as the importance of shipping and packaging medical devices.
