Medical device traceability enabled by unique device identification (UDI), draft technical report published

17 April 2014

In February 2014 draft technical report NPR-CEN/TR 14060 was published. This technical report describes the current situation for medical device traceability in Europe and identifies key elements to establish a comprehensive European traceability system that would provide full traceability to the individual patient level.
The assigned Unique Device Identification (UDI) should be captured in a carrier (e.g. barcode or RFID), which is present on the packaging or directly on the device itself.
The Commission Recommendation 2013/172/EU of 5 April 2013 was used in the development of this document (World Packaging Standardisation Newsletter, April 2014).
Click here for more information about the technical report.
Click here for the Commission Recommendation.
Click here for more information about the World Packaging Standardisation Newsletter (WPSN), including how to subscribe.

This item is also included in our monthly overview, the NVC Members-only Update. If you have any questions, please contact us:, +31-(0)182-512411.