UDI: 5 Opportunities You May Not Have Considered

It may only be three letters, but for some manufacturers, UDI is a four-letter word. There are others who see the regulation as an opportunity to better understand product performance, speed up regulatory approval and coverage decisions, and improve the cost of doing business with customers. For those not familiar with the acronym, an increasing number of regulatory bodies around the world, including the U.S. FDA and the European Commission, are requiring manufacturers to fulfill three primary requirements: 1) assign unique device identifiers (UDIs) to their products; 2) label those products with the UDIs in both human and machine (think bar code, RFID) readable formats; and 3) publish additional attributes about those products to regulatory databases. Compliance with those requirements is an ongoing effort (not a one-time project) that requires coordination across a wide variety of functions within a manufacturer organization, from regulatory affairs and printing to marketing and information technology. Data governance is also critical, especially as more countries and regions of the world begin to publish their own UDI regulations. China recently published its draft regulations, and UDI activity is underway in Saudi Arabia, Taiwan, South Korea, and Brazil, to name just a few. Despite efforts by regulators to harmonize their UDI regulations according to guidelines published by the International Medical Device Regulatory Forum, even minor differences in regulatory language an...
Source: MDDI - Category: Medical Devices Authors: Tags: Labeling Source Type: news

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