Governments around the world have adopted regulations for the proper identification and subsequent traceability of medical devices to help identify counterfeit products, facilitate the recall process and create greater efficiencies.
One of the norms adopted in several countries is a system to identify medical devices through a unique identifier, commonly called Unique Device Identification (UDI). The carrier of this information can be a barcode, a Data Matrix (2D code) or RFID tag, for example.
The information required by law in those data carriers can vary according to the classification of medical devices in each country. For example, in the U.S., depending on the level of risk to the patient/user, medical devices are categorized in Class I, Class II and Class III. In the European Union, Class II includes subclasses A and B. In both cases the scale goes from devices with the least risk (I) to those with the most (III). In all three classes, the batch and product number is commonly required; however, a serialized UDI is mandatory only in specific devices belonging mostly to Class II and Class III.
A UDI code consists of various identification components.
Whether they go by generic names as specified by the FDA or specific ones as standardized by GS1, the information is similar.
A UDI is a unique, alphanumeric code, composed of two parts:
Because of the size and complexity of the medical device industry, regulations will be applied in different phases aligned with the device classification in each country. Here are some examples of the laws in place:
