In the barcode industry, there is considerable dialogue about (UDI) Unique Device Identification and (MDR) –Medical Device Regulation. We read and hear all about the initiatives and the deadlines, but why are these compliance requirements so important….

 

• These compliance regulations provide for more accurate reporting, content review and the ability to report on device identification and correction.

 

• Provides for standards that can be incorporated in the world- wide distribution of medical devices.

 

• Provides standards for identification and tracking of all medical device manufacturing. UDI and MDR compliance labeling provides for precise identification of the device and the production information for that device.

 

• Allows for the tracking and standard identifiers to allow the manufacturer or distributor to manage potential recalls.

 

• UDI and MDR provide the basis for securing the product through the distribution and supply chains. This increased product security reduces the opportunity for counterfeit products to be introduced into the distribution chain.