Medical Device Label Development
Labeling the completed product is a vital aspect of final packaging at QTS. Using our validated label printing system, we take customer-supplied data to design and print labels that communicate materials specifications, lot numbers, expiration dates, instructions, logos and any significant information the product requires, including barcodes.
Our label design experience and validated software ensures compliance with the EN980 and AAMI label content guidelines. We additionally assist many customers with implementing their GS-1 and HIBC package barcodes.
Read more about the QTS label standards and guidelines, or for more information, please feel free to contact us.
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QTS utilizes the label standards and equipment listed below:
- EN980 – Graphical symbols for use in the labeling of medical devices.
- ISO 15223-1 – Symbols to be used with medical device labels.
- GS-1 & HIBC – Compliant Barcoding.
- Thermal Transfer Printer (300 DPI & 600 DPI).
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Unique Device Identification (UDI):
Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) includes language related to the establishment of a UDI (Unique Device Identification) System. The eventual regulation will require medical devices to bear a unique product identifier on the product labeling.
The FDA is expecting to publish the final rule in June of 2013 with implementation for Class III device labeling in late 2012/early 2013. Class II and I implementation follows on year 3 and 5, respectively.
The FDA's proposed end goal of patient safety, traceability, visibility and accuracy translates into a system that uniquely identifies the device through distribution and use. In short, a unique identifier (likely a machine-readable code) will soon become a statutory requirement of medical device labeling.
There are two existing barcode standards that satisfy UDI requirements; GS1 and HIBCC. Both are compliant to ISO 15459, and each ensures uniqueness of the UDI data. However, there are several differences between HIBCC and GS1, including:
- Start-up and ongoing registration costs
- Barcode symbologies supported
- Mapping of existing catalog numbers to unique device identifiers
- Ease of ensuring uniqueness within your quality system
The UDI data will be uploaded into an FDA-controlled database; unique from existing EDI, UPN and GDSN databases.
Contact QTS for more information on UDI implementation for your device company.
UDI Resources
FDA.gov: Unique Device Identification
FDA's proposed UDI Rule (readable format)
Federal Register: Proposed UDI Rule |
