Unique Device Identification (UDI) is a system for the unique identification of medical devices.
It was introduced with the EU Medical Device Regulation (MDR) to improve the traceability of products throughout their entire life cycle.
UDI supports authorities and manufacturers in market surveillance and enables reliable traceability of medical devices. Manufacturers are required to label their products accordingly and store the relevant information in the European database EUDAMED.
UDI consists of two central elements:
• UDI-DI – static product identifier
• UDI-PI – product-specific information, e.g. batch or serial number
In addition, there is the Basic UDI-DI, which links regulatory documents such as certificates and EU declarations of conformity.
In practice, structuring the UDI and registering data in EUDAMED can be challenging for many manufacturers – especially in connection with technical documentation.
Do you have questions on this topic?
BEO BERLIN supports manufacturers with regulatory questions relating to MDR, technical documentation and market access.
