What is a UDI and the GUDID?
The Unique Device Identifier (UDI) is a system used to mark and identify medical devices within the healthcare supply chain. On September 24, 2013 the Food and Drug Administration (FDA) established a UDI system that requires manufacturers to include both a plain-text version of the identifying data, and a version encoded using Automatic Identification Data Capture (AIDC) technology such as linear or two-dimensional bar codes, RFID tags, etc.
- 09 Jun 2021EC publishes FAQ on the European Medical Device Nomenclature
- 19 May 2021EC publishes guidance addressing MDR requirements in the event EUDAMED is not fully functional
- 25 Mar 2021Is your software considered a medical device under the EU MDR/IVDR?
- 15 Mar 2021EC publishes MDR guidance on Custom-Made Devices
- 17 Feb 2021Register now for our HIBCC EU UDI Webinar