Wondering if you need to integrate unique device identification (UDI) into your quality management system (QMS)?
Short answer: Yes.
During the January 27, 2022 webinar, “Unique Device Identification | Aligning to a Single Approach,” Redica Systems GMP Medical Device Expert Mark Agostino addressed the areas medical device manufacturers need to consider when it comes to integration of UDI in a manufacturer’s QMS.
“You need to develop a holistic plan for implementing UDI into the quality management system QMS,” he said. “UDI is going to touch upon a number of different functional areas.”
Agostino pointed to six particular functional areas that need to account for UDI in a medical device manufacturer’s QMS:
- Design and Development
- Postmarket Surveillance
- Responsibilities of Economic Operators
- Supply Chain
- Documentation and Records
[Related: Download a FREE analysis of 100 FDA form 483 observations involving UDI issues and see which categories these observations fall under.]
For additional guidance, Agostino referenced a document from the Medical Device Coordination Group, MDCG 2021-19 Guidance note integration of the UDI within an organization`s quality management system.
“It talks about how to integrate UDI within your organization’s QMS,” he explained. “One of the aspects that they encourage you to take into consideration is an analysis of expectations and needs of the different stakeholders. These would be your economic operators. So, economic operators would be everything from your device manufacturers, your distributors, the importers. And for the EU Medical Device Regulation (EU MDR), that also would include authorized representatives. Also, you need to take into consideration healthcare institutions and professionals, patient users, and insurance providers.”
[Author’s Note: For more on economic operators, read the article, “EU MDR and Economic Operators for Medical Devices.”]
“And then another thing that is recommended is maybe developing methods and use cases to verify continuous compliance of your UDI-related QMS processes,” Agostino said. “So, to have a continuous, somewhat internal audit and internal check to make sure that you are maintaining that level of compliance.”
Design and Development UDI Requirements
When it comes to design and development, he recommends making UDI decisions early, such as whether it will be placed on the device itself or the packaging. It is important to make these decisions early as they impact the development of the actual UDI itself and required technical documentation.
“This is something that the sooner you are able to work through a list of questions or requirements, the better,” he said. “You would also be setting up for not having any delays or issues when it comes to time for doing any regulatory submissions.”
During this stage, it is critical to be aware of the different requirements of UDI issuing agencies. For U.S. FDA and the EU Medical Device Regulation (EU MDR) requirements, there are three shared accredited issuing agencies between the two regulatory bodies, GS1, Health Industry Business Communications Council (HIBCC), and the International Council for Commonality in Blood Banking Automation (ICCBA). Each of these issuing agencies has its own requirements.
Yet not every country or region recognizes all the issuing agencies. This presents a QMS challenge (Figure 1). GS1 is generally well accepted globally, but if one of the other issuing agencies is selected, the level of global acceptance is something that needs to be reflected in the QMS.
UDI QMS Requirements for Production
When it comes to production, manufacturers should decide when, where, and how the UDI carrier should be applied. If it is placed on the packaging, that means determining the levels of packaging needed to support the UDI.
“The U.S. FDA actually, for all device risk classes with the exception of certain class I devices are expected to have a UDI marking on the device,” Agostino said. “The U.S. FDA is by far the most mature process for UDI. They have already implemented, not only a lot of guidance, but just a lot of regulations governing the types of devices that you need to incorporate a UDI marking on the device, if it allows.”
Also, from a production standpoint, it is important to incorporate UDI labeling requirements into device master records. A QMS needs to include UDI labeling requirements that actually reflect the correct documentation along with verification of device history records. This portion of the UDI process also needs to be validated and well established within the manufacturing process.
[Author’s Note: For information on production-related issues medical device manufacturers need to avoid, read the article, “The 7 Most Common FDA 483 Observations Involving UDI.”]
UDI Supports Postmarket Surveillance
UDI information is expected to be included in postmarket surveillance reports, including serious incident reports, field safety, corrective actions, customer complaints, etc. Including this information can help identify trends regarding quality issues.
“The more information and data you have at your fingertips, basically to identify where devices exist and when product quality issues have been identified, helps prevent quality issues from propagating,” he said.
UDI and Economic Operators
As mentioned previously, economic operators include device manufacturers. Manufacturers are responsible for assigning the UDI and placing the UDI carrier. Other economic operators verify that the UDI assigned by the manufacturer is correct. This requires manufacturers to maintain appropriate documentation.
“Ultimately, the goal is to have all economic operators and health institutions to store and keep electronic means of UDI for these devices,” Agostino said.
UDI Enters the Supply Chain
“From a supply chain standpoint, understanding the roles and responsibilities of the management in the reporting of UDI is critical,” he said. “From a supply chain perspective, you are ensuring UDI is managed throughout the supply chain straight from manufacturing, all the way to the end-use of the patient.”
This means that documentation throughout the supply chain process is critical, with all records tracked throughout the entire process.
More on Documentation and Records
Managing UDI is the culmination of three key aspects: data, labeling, and the QMS. Data consists of the information contained in the records that designate the correct UDI. This needs to be communicated to appropriate UDI databases.
“The data is basically the single source of truth,” Agostino said.
The labeling, he said, must be read to actually represent the medical device, if necessary.
“And then you have the QMS, which is all the processes and procedures that exist to support the necessary actions for the UDI system. This is everything that helps to govern all the functions you need to be responsible for.”
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