All medical devices sold in the region are required to have Unique Device Identification (UDI) numbers under the MDR.
Only products that comply with EU importer 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.
It Is the first time In a regulation that the Importer Is jointly liable like the manufacturer In placing products In the European Union.
