Unique Device Identification (UDI) System

An Easier Way to Achieve UDI Compliance

While manufacturers address UDI compliance, they will also capitalize on the benefits of streamlining operations through uniquely identifying and improving patient safety, traceability, and operations. Medical devices that are deemed critical are subject to this mandate, starting with the most critical (Class III) and ending with least critical (Class I) devices.

Sparta UDI Compliance Solution for Med Device Companies

The UDI regulation requires that 25 fields are packaged and sent to Global UDI database (GUDID) using XML transport and delivery. Sparta's UDI solution performs this packaging and transmission to the GUDID gateway. Once the gateway receives, it sends back the acknowledgement which is tracked as part of the workflow. This provides the traceability for the initial UDI registration. Any subsequent product change, initiated through the change control process is handled the same way, thus maintaining the history of UDI updates as per the mandate.

Medical device companies also trust Sparta for eMDR, eMDV, product registration tracking, and other electronic reports and submissions. Extensive practical experience of XML and electronic UDI submissions provides a rapid implementation of the UDI solution that is risk-free.

European UDI Status

International Medical Device Regulators Forum (IMDRF) and European Union (EU) are working with the US on a similar system as the US FDA UDI Final Rule to make sure the proposals are standardized and information can be exchanged by regulators throughout the world. Several other countries and regions are also looking to implement a UDI system. The IMDRF includes representation from US, EC, China, Japan, Canada and others.

EC’s proposal would amend Directive 2001/83/EC, Regulation (EC) No 178/2002 and 1223/2009 to require manufacturers to meet the device ‘traceability obligations’. Specific information contained within the UDI will also depend on the risk of the medical device in question. For Class I (low risk) medical devices, the UDI's production identifier will need to include the expiration date and/or manufacturing date. Class II (a/b) devices will need to include lot and batch numbers. Class III (high-risk) devices will need to include batch/lot numbers or a serial number. Lower-risk devices can include more information than is necessary, such as that required for a Class III device, but high-risk devices cannot include less than is required.

Whatever changes are made to the UDI program, Sparta solutions offers the flexibility to achieve compliance. Learn more about the platforms used by other medical device companies below.

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