Import of Medical devices to the USA will have to meet UDI requirements in the nearest future

Starting from 24 September 2014 all suppliers of Class III Medical Devices should meet the UDI requirements. In the period of next two years all medical devices should bear a unique device identifier (UDI) which will help the FDA identify product more quickly.
A UDI is a unique numeric or alphanumeric code. This new UDI rule of Food and Drug Administration (FDA) requires a numeric or alphanumeric identifier to be placed on the label of most medical devices. The UDI would be required to appear both in a text format and in automatic identification format. The form of this UDI would be consistent with current barcoding configurations (GS1 website, 12 June 2014).
Click here for the original article (in Dutch).
Click here to read the Unique Device Identification System Final Rule.
Click here for more information on the FDA requirements and compliance dates.

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