26 Aug Global Unique Device Identification (UDI) – Steps for Successful UDI Compliance
Review our HOW TO tips for setting up a labeling system for Unique Device Identification compliance. The next deadline for UDI Compliance is quickly approaching
(Click here for more information on deadlines)
How to set up your labeling system
Here is a final checklist of points to consider to help you select the best labeling software for UDI compliance and GUDID submission.
› Make sure that the application provides 21 CFR Part 11 compliant technologies: medical device manufacturers are required to implement controls, including system validations, electronic signatures and documentation, for any software and systems involved in processing the electronic data that must be maintained by the predicate rules (the underlying requirements) or submitted to the FDA.
› Ensure that the label design software can print the GS1 and Health Industry Bar Code (HIBC) and generate the automatic identification and data capture (AIDC) technology for placing a UDI on labels for medical de-vice packaging. It is crucial that the solution you choose provides an efficient, easy-to-use way of meeting UDI requirements. The best practice is, if space permits, use the linear Code 128 barcode type, but make sure it meets the size requirements. If you are unsure or if you have very limited space on the label, use the two dimensional DataMatrix code. Either way it’s a good idea to check the barcode quality with verification equipment or with your issuing agency. They may require you to pay a small fee for the verification.
› Consider thermal transfer labels as a means of putting UDI on device packaging. These are cost effective and use high-resolution printing capabilities for barcodes, graphics and text. The completed label is high contrast for easy scanning.
› Consider implementing a label a management solution that includes a document management system that adheres to 21 CFR Part 11, to simplify label creation, revision control and label approvals. This will give you the ability to manage document storage, user access and print history.
› Consider using a label management solution that includes quality management features such as an electronic label catalog of all of your labels and the ability to graphically compare label revisions or label variations.
- Windows Server
Use a server that hosts the document management system and integration software (if you are going to connect to MES or ERP systems) for your label management solution. You will also need windows PC’s for the label designer and print operators.
Thermal transfer printers offer the best support for self-adhesive labels and on-demand label printing in production environments.
- Direct Marking Equipment
Here too, you may need new hardware, including laser etching equipment (for marking reusable devices).
- Vision Inspection System
Select an in-line verification system to ensure that print quality for your label is maintained to the standards required by your issuing agency.
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For more information, visit the FDA website.
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