FDA -EU Unique Device Identification Database

FDA -EU Unique Device Identification Database

Some info taken from Wikipedia

UDI system  Europe , will be  ready and released by  the European Commission’s regulations probably in 2016. 

 The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States. It was signed into law on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007. This act includes language related to the establishment of a Unique Device Identification System. When implemented, the new system will require:

  • The label of a device to bear a unique identifier, unless an alternative location is specified by the S. Food and Drug Administration(FDA) or unless an exception is made for a particular device or group of devices.
  • The unique identifier to be able to identify the device through distribution and use
  • The unique identifier to include the lot or serial number if specified by FDA

A national UDI system will create a common vocabulary for reporting and enhance electronic tracking abilities. Currently, analysis of adverse event reports is limited by the fact that the specific devices involved in an incident are often not known with the required degree of specificity. Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems is problematic. Reliable and consistent identification of medical devices would enable safety surveillance so that the FDA and manufacturers could better identify potential problems or device defects, and improve patient care.

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