Unique Device Identification

Unique Device Identification (UDI ) is a worldwide system for a uniform product labeling for medical products and was developed in the United States. UDI to be machine-readable identifier ( for example, bar code) and applied in plain text on the product. UDI is the key to a UDI database (Unique Device Identification Database; UDID ), which will contain a lot of information about the products.

Description

The UDI system goes back to an order from the U.S. Food and Drug Administration ( FDA) to improve patient safety and to facilitate product recalls and improve market surveillance. The former international initiative for harmonization of regulatory requirements for medical devices, GHTF (Global Harmonisation Task Force ) published in September 2011 for the first time a guideline for the implementation of UDI. As the successor organization since 2011, the International Forum of regulators for medical devices ( " International Medical Device Regulators Forum " - IMDRF ) this worked. The Directorate General for Health and Consumers of the European Union is a member of IMDRF Management Committee.

In Europe, a UDI system is made ​​mandatory and the new Medical Devices Regulation ( Medical Device Regulation - MDR) regulated. All medical devices fall within the scope of UDI, as they fall under the definition of medical devices IMDRF (International Medical Device Regulators Forum ).

UDI System

The UDI system should lead to an increase in patient safety and allows the capture of patient-related material consumption and thus also the process optimization in healthcare, for example, the data could einfliesssen in the future in the electronic health record. In addition, it supports discovery in product recalls and notifications on adverse events by qualified and comprehensive information.