Imagine a scenario where a patient receives a life-saving medical device, only to find out later that there’s a recall due to a critical defect. How can manufacturers quickly identify and notify every user of the affected device? Enter the hero of our story: digital labels.
In today’s fast-paced medical industry, digital labels are like the unsung superheroes, swooping in to ensure traceability and compliance, all while maintaining a sleek and affordable profile. These small but mighty labels are revolutionizing the way we track medical devices from the production line to the patient’s hands, ensuring safety and reliability every step of the way.
Regulatory Requirements for Traceability
There are stringent requirements for traceability, including regulations and standards such as:
- U.S. FDA Unique Device Identification (UDI) system
- E.U. Medical Device Regulation (MDR)
- Global Unique Device Identification Database (GUDID)
- ISO 13485:2016 for quality management systems
Digital labels for traceability meet these standards by providing unique identification for each product, tracking and managing inventory, and enabling rapid recall.
Advantages of Digital Labels for Traceability and More
Using variable data printing, manufacturers can create serial numbers, lot codes, and manufacture data so that each product has its own identity and history.
Digital labels also provide precision and flexibility in design. You can customize labels for specific products easily without pre-printing or stocking label SKUs. Labels and decals can be visually appealing and convey important information, balancing legibility with durability and color accuracy. This enables manufacturers to create a cohesive brand identity, pivotal in product and brand recognition.
Counterfeiting has increased significantly over the past few years and continues to plague the healthcare products industry. Digital labels can include anti-counterfeiting measures such as unique color combinations or microtext.
Tapecon’s Digital Label Solutions
Tapecon offers a full line-up of medical device compliance labels, including innovative solutions for digital, customizable medical labels such as:
- Digital printing of medical devices, eliminating the need for plates or screens
- Screen printing on a variety of substrates
- Flexographic printing for seamless integration of printing and converting
- Variable data printing (VDP) to print multiple SKUs per run
- Printing of stick-to-skin materials
Some digital printing is also FDA-approved for indirect skin contact or meets FDA guidelines for products that must be non-toxic and odorless.
Future Trends in Digital Labeling
In February 2024, the FDA amended the current good manufacturing (cGMP) requirements in its Quality System Regulation (QSR) standards for medical devices. The experts at Tapecon stay on top of changes to industry standards that impact label design, functionality, and production so you can be confident you comply with all regulations.
Emerging trends include smart labels and integrating RFID or NFC technology for enhanced tracking. Device manufacturers are also starting to incorporate augmented reality, allowing labels to provide additional information when scanned with a smartphone.
As regulations become more complex and data requirements increase, digital labeling technology provides the flexibility to adapt.
Let’s Make Something Great
Ensure regulatory compliance and enhance traceability with Tapecon’s advanced digital labeling solutions. Our digital labels provide unique identification, anti-counterfeiting measures, and customizable designs to meet stringent standards like UDI, MDR, and ISO 13485.
With expertise in digital printing, variable data printing, and emerging trends like RFID integration, Tapecon helps you stay ahead of regulations and market demands. Partner with us to achieve precision, flexibility, and brand cohesion in your medical device labeling.
