In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification (UDI) system designed to adequately mark and identify devices through the healthcare supply chain (distribution and use).
The FDA, the European Commission and other regulators have made patient safety a strategic priority by developing legislation to ensure the proper identification and subsequent traceability of devices.
The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative.
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:
Learn more about UDI regulation and the benefits of UDI implementation for your business by watching our webinar Benefits of UDI and Tips on Optimizing Implementation.
Most medical devices do not require a serial number.
For some of the class II and III, the FDA can require a serial number.
Some clients can personally decide to serialize without it being mandatory for them.
The implementation of UDI is somewhat complex as regulations vary from country to country, and not only depend on where the medical devices are produced, but also where they are distributed.
The identification requirements in Europe differ from those in the US and other regions.
In addition, the deadlines to comply with legislations are also different, depending on device classification and country. And sometimes, even within a single country, there can be differences. For example, the FDA lists a number of exceptions and extensions to compliance.
As a result, UDI is like a moving target with diverse requirements that will change and evolve over time.
So as a manufacturer of medical devices producing and/or distributing products in one or several countries, how do you go about ensuring that your company will be able to comply with and adapt to changing requirements, without disrupting business every time?
Get answers by reading our white paper about UDI implementation and the role of scalable vision solutions.