In order to comply with the legal requirements of the FDA, medical device manufacturers must comply with the UDI (Unique Device Identification) requirements in the future.

All medical devices, which fall under the definition of medical devices of the IMDRF (International Medical Device Regulators Forum) formerly GHTF (Global Harmonization Task Force), belong to the scope of UDI.

All manufacturers exporting to the USA must have implemented the globally uniform system for the identification of medical devices in their ERP system within the next few years. For the implementation of UDI, medical products were divided into various risk classifications.

 

 

 

 

 

 

 

 

 

 

Timetable for FDA UDI implementation

  • High-risk medical devices (Class 3) : 1 year after entry into force of the law (24.09.2014)
  • Medium-risk medical devices (Class 2): 3 years after entry into force of the law (24.09.2016)
  • Low-risk medical devices (Class 1) : 5 years after entry into force of the law (24.09.2020)