Medical device labeling: The unsung pillar of patient safety and compliance

Having the correct documentation is a key consideration in achieving outcomes for medical device manufacturers. Before a device can be shipped or delivered, it must have valid labeling and instructions for use (IFUs). 

Mislabeling remains a recurrent factor in product recalls. In 2024, the US Food and Drug Administration mandated recalls for devices with misleading or unclear labeling that could result in improper use, dosage errors, or incorrect treatment. 

The role of labeling is evolving. Regulatory landscapes are becoming more stringent with updated certifications under frameworks like the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR). Looking ahead to 2026, the Health Technology Assessment Regulation (HTAR) will apply to selected high-risk medical devices. 

This dynamic environment means that labeling can be a key factor in lagging the medical device product lifecycle and is often subject to change and increasing complexity. 

Key labeling challenges 

Medical device manufacturers face several inherent challenges in managing their labeling process: 

1. Label data integrity: Ensuring accuracy, traceability and control of label data are key factors. If the information on the label is false, missing, or misleading in any way, it may not only risk contravening regulations but also lead to adverse outcomes for patients. 
2. Translating content to the target client: Translating content for global markets is a significant pain point for labeling professionals. Without a centralized repository for both source and translated content, medical device manufacturers risk errors in managing individual labeling elements. 
3. Navigating regulatory requirements: Escalating compliance expectations also results in intensified scrutiny and complexity. Simultaneously, there are also harmonization efforts underway. Consortia like the International Medical Device Regulators Forum (IMDRF) are issuing guidance on globally harmonized labeling principles for medical devices, such as guidance on the content of the label, IFUs, and information intended for the patient, to support safe and effective use. 
4. Unique device identification expansion: The global implementation and varying applications of unique device identification (UDI) databases across different health authorities create additional complexity. Manufacturers must manage the creation and assignment of a UDI to each specific device or packaging, as well as generating and populating all the associated data elements. In addition, they must ensure its consistent application across diverse regulatory frameworks, with limited capabilities to do so efficiently. 
5. Market pressure: The pressure of getting products to market may clash with the demands of accurate, compliant labeling. Balancing speed and predictability for business success requires overcoming the complexities of label generation and approval. 

What's the solution? A comprehensive approach 

Digital transformation is key to ensuring: 

• Ability to connect the dots on disparate data sources 
• Oversight over all labeling elements 
• Risk reduction and mitigation of non-compliance factors 
• Centralized, granular change control 
• Workflow redundancy elimination 
• Mastery over complex workflows 
• Assured traceability of translated content and other critical data 

Medical device labeling is evolving. Present challenges and pressure require these solutions to move forward to a future that prioritizes patient safety and compliance.