Accurate and compliant labeling is a cornerstone of medical device manufacturing, yet it remains one of the most complex and challenging aspects of the industry. With the regulatory landscape continuously evolving, manufacturers must navigate a labyrinth of global requirements while ensuring workflows are efficient and error-free.  

This article will guide you through the foundational requirements in the US and EU, explore common challenges, and share best practices to help you streamline your labeling processes and maintain compliance.

What is Medical Device Labeling?  

Medical devices encompass a wide range of products designed to diagnose, treat, or prevent medical conditions. If you’re unsure whether your product qualifies as a medical device, the FDA’s classification tool can help clarify.  

But what exactly constitutes a "label"? According to the FDA's definition, it includes all written, printed, or graphic materials associated with a medical device. This extends to Instructions for Use (IFUs), packaging, and any accompanying materials.

Key Regulatory Requirements for Medical Device Labeling  

Both US and EU regulations share a commitment to ensuring safety, efficacy, and transparency. However, the nuances between these frameworks require manufacturers to tailor their processes accordingly.  

US FDA Requirements  

The FDA’s labeling requirements focus on providing clear, accurate, and comprehensive information about the device’s use, safety, and risks. Labels must include details like:  
- Device name and intended use
- Directions for use
- Warnings and precautions

You can find a complete overview on the FDA's device labeling page. For further insights into FDA requirements, explore our guide to 21 CFR Part 211.

EU MDR Requirements  

The EU MDR emphasizes multilingual compliance, CE marking, and detailed Instructions for Use (IFU). Essential label elements include:  
- CE marking  
- Unique Device Identifier (UDI)  
- Appropriate symbols and pictograms for clarity  

For detailed EU MDR labeling requirements, refer to the official documentation. Learn more about how our software supports EU MDR compliance on our dedicated page.  

Common Challenges in Medical Device Labeling  

Keeping Up with Regulatory Changes
Frequent regulatory updates can turn compliance into an ongoing challenge. Each change might require updates to tens of thousands of labels, creating a significant headache for suppliers. To stay ahead, it's crucial to have software in place that can quickly and easily manage these mass label updates—keeping you ready for whatever changes come next.

Managing Multilingual Labels
For global suppliers, ensuring labels are understood by consumers across different regions is critical. Multilingual compliance, especially under EU MDR, requires precise and culturally relevant translations—adding another layer of complexity to the labeling process.

Complex Approval Processes
The approval workflows for Class II and III devices can involve multiple stakeholders, often leading to long delays. That's why it's essential to use an intuitive, end-to-end platform that streamlines the approval process and keeps everything running smoothly and efficiently.

Discover how Kallik’s medical device labeling software helps mitigate these challenges. Having been built with compliance in mind, our end-to-end Veraciti™ software makes all of the above easier than ever.

Best Practices for Ensuring Labeling Compliance  

Automate and Centralize Processes  
End-to-end software solutions streamline label creation and updates by automating key tasks, reducing manual errors, and ensuring consistent regulatory compliance. Centralizing your labeling processes in one platform allows you to quickly implement changes across multiple regions, ensuring your labels are always up to date with the latest requirements and eliminating time-consuming manual revisions.

Implement Robust Version Control  
A solid version control system keeps track of all label iterations, ensuring only the most current version is in circulation. This reduces the risk of distributing outdated labels and simplifies audits, as you can quickly access historical versions and verify compliance. It also fosters collaboration by providing clear visibility into changes and approvals, keeping your labeling process secure and efficient.

Digital Proofing and Approval Workflows  
Automated proofing and approval workflows speed up the approval process by ensuring labels are reviewed and signed off quickly and accurately. With digital tools, you can spot errors early, streamline collaboration, and reduce delays, ensuring that labels meet regulatory and internal standards efficiently, without the bottlenecks typical of manual approval processes.

Learn more about how Veraciti's automated tools can help with your medical device labeling on our label management page.  

Leveraging Labeling Software for Compliance  

Kallik delivers speed to market, compliance and change management for complex product labeling and artwork portfolios that significantly challenge medical device organizations.  Whether driven by localized market requirements, merger and acquisition or the launch of a new product, our software can ensure that your organization completes artwork and labeling projects with unrivalled speed and compliance. 

With fully customizable role-based digital approval flows, label automation, advanced reporting, and full audit logs, you can ensure total regulatory confidence in your medical device product labeling and artwork. 

One example is our partnership with Ossur, where our solution enabled seamless global labeling compliance. By centralizing and standardizing IFU data, Össur gained complete visibility and streamlined the creation and approval of Instructions for Use (IFUs) across hundreds of products. This transformation reduced cycle times, cut translation costs, and ensured compliance while simplifying future regulatory updates. Veraciti’s automation and phrase reusability not only improved operational efficiency but also enhanced the customer experience by delivering clearer, standardized product information. Read the full case study here. 

Kallik has extensive experience partnering with medical device organizations and manufacturers. Our label and artwork management solution, Veraciti, is constantly evolving to meet the dynamic needs of the medical device industry. Contact us today at enquiries@kallik.com to discover how Kallik can streamline your labeling and artwork management process. Book a demo to see how Kallik can transform your labeling process.