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.
UDI Compliance with Sparta Systems
When you partner with a solution provider that has the experience and past success dealing with similar mandates, you choose a risk-free solution. Sparta Systems' EQMS is used by industry leading medical device companies for electronic regulatory submissions.
The UDI regulation requires that 25 fields are packaged and sent to Global UDI database (GUDID) using XML transport and delivery. Sparta Systems eReporting solution performs this packaging and transmission to the GUDID gateway, much like how the eMDR is performed. 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 Sparta Systems’ change control process is handled the same way, thus maintaining the history of UDI updates as per the mandate.
EQMS is used by medical device companies for eMDR, eMDV, registration tracking and other electronic reports and submissions. These solutions use the Sparta Systems' eReporting tool, which is the same technology that is part of the UDI software solution for collecting, packaging and delivery of the UDI field set. This experience coupled with close working relationship with the FDA, and extensive practical experience of XML and electronic UDI submissions provides a rapid implementation of the UDI solution that is risk-free. Using Sparta’s EQMS solutions for UDI is a simple extension, not a new product development, providing companies with a risk free solution for UDI compliance.
EU 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 harmonized so that the 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.
To learn more about the Sparta Systems' UDI solution and how it integrates with other quality processes and enterprise systems, click here.