In future, medical products will be marked with a world-wide UDI (Unique Device Identification) marking system. The aim is to simplify keeping track of medical products and market surveillance and to fight imitations.
UDI guidelines have been developed on a global level which provide regulatory authorities with a framework to develop their own UDI system. As early as 2007, the USA signed a bill into law to facilitate the introduction. In Europe the implementation by 2014 is probably planned as part of an overhaul of medical product guidelines. Countries will supposedly be granted a three-year transition period to implement the changes nationally.
The complete UDI consists of a product and production code (identifier) which is stored in a central UDI database. A suitable storage medium for codes might be the EAN 128 or Data Matrix. The UDI system is actually supposed to be implemented step by step: Starting with medical products in the high risk category and ending with the lowest risk category.
A successful implementation requires that the entire delivery chain works without a hitch. The project will only come off if regional authorities, users like retailers, hospitals or care provider services, make use of the UDI system to its full extent and if manufacturers and users come to grips with UDI in good time.