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Anti-counterfeiting is one of the main public health targets for medical devices that can be achieved through the implementation of the unique device identification (UDI) system provided in respect to the EU’s new Medical Device Regulation (MDR) and US’ Code of Federal Regulations Title 21 referring to labelling for medical devices (21 CFR 801 Subpart B). Other targets like safety communication promotion, reduction of inappropriate use of the device, management of adverse events, incident reporting, and efficient device recalls can be achieved through the use of a unique identifier combined with the creation of a central UDI database.
The UDI must be placed on the medical device and on its related packaging and should include both a human readable interpretation (HRI) text for HRI of the data characters and automatic identification and data capture (AIDC) text for the automatic identification through bar codes, smart cards, biometrics, and radio frequency identification (RFID), also known as AIDC technologies.
A device can be more easily counterfeited if the UDI information is stamped or marked on a label applied to the device, just by removing/substituting the label. On the other hand, it is much more difficult to falsify products if the same information is directly laser marked on the surface of the medical device itself. There are medical devices that must be directly marked with a unique device identifier (CFR 21 Sec. 801.45 or EU MDR Part C 4.10 about the UDI system in reusable devices); in general if the device is intended to be used more than once and intended to be cleaned or disinfected before each use.
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