8 Common Regulatory Pitfalls in Medical Device Labelling

Medical devices should be properly labelled so that they are used as intended. This increases safety and reduces risk. Correct labeling of medical devices empowers healthcare professionals and patients to make informed decisions. Mistakes in medical device labelling can lead to regulatory penalties, product recalls, or even patient harm. Hence, it is vital to comply with regulations for labelling medical devices. Moreover, compliance with labelling guidelines will lead to correct usage and handling of medical devices.

Medical devices are one of the pillars of the healthcare industry. Regulatory guidelines are in place to monitor the efficacy, quality, and safety of these devices. Notably, medical device labels are used to guide users. Hence, they play a pivotal role in patient safety. Therefore, guidelines have been formulated for labelling medical devices. Mandatory compliance is required to deliver safe and effective healthcare to the patients.

Importance of correct medical device labelling

Medical devices are used to diagnose, monitor, and treat patients. Thus, proper identification, correct usage, and patient safety are vital for effective healthcare delivery using the medical device.  Medical device label is essential for conveying vital information related to the medical device. Clear and easily understandable medical device labels will help both healthcare professionals and patients. Device labels improve user understanding, effective use of the device, and patient safety. Labelling requirements have been framed to provide guidelines to manufacturers on how to properly label their products. The guidelines are focused on patient safety and effective and efficient healthcare delivery. We have highlighted the importance of medical device labels:

• Medical device labelling conveys critical information about the device, such as its purpose, usage instructions, any warnings, and manufacturer details and contact information.
• The primary goal of medical device labelling is proper identification, handling, and administration of medical devices.
• The device labels provide information, such as sterility details, expiry dates.
• It provides the traceability code.
• Proper medical device labelling demonstrates the manufacturer’s commitment to improved patient outcome and safety.

Hence, labelling requirements for medical devices are in place to ensure accurate and comprehensive medical device labelling.

8 common pitfalls in medical device labelling

1. Non-compliance with regional regulations: Regulations for labelling medical devices slightly vary from one regulatory market to another. It is vital to label your medical devices per your target market regulations. Non-compliance with regional regulations will lead to market access denial, regulatory rejection, or customs holds.
2. Missing or incorrect unique device identification (UDI): Non-compliance with UDI guidelines or formatting rules is a common pitfall in medical device labelling. Also, in certain cases, the UDI may be completely missing from the medical device label. Non-compliance with UDI guidelines hinders traceability and post-market surveillance.
3. Lack of language translations for international markets: Medical device labels not translated into official languages of target markets will lead to regulatory non-compliance. It is important to accurately translate labels and Instructions for Use (IFU) into the regional target market language.  
4. Improper use of symbols and icons: Use of non-standard or unclear symbols in medical devices will lead to regulatory repercussions. This will lead to misinterpretation by users. Additionally, use of outdated or incorrect regulatory symbols will also be considered regulatory non-compliance.
5. Omitting critical safety information: Missing warnings, contraindications, expiry dates, or handling instructions in the labels can have negative repercussions. This can lead to patient harm and liability risks, thereby lead to sanctions.
6. Failure to update labels post changes: Medical device labels not updated after design changes, manufacturing changes, or post-market findings is also a common issue often overlooked. This will lead to regulatory non-conformity and outdated usage instructions.
7. Neglecting electronic labeling requirements: Not providing e-labels where required, e.g., for hospital-use devices, will lead to regulatory non-compliance. It is vital to ensure the e-labeling meets regulatory format, accessibility, and traceability standards.
8. Inconsistent information: Inconsistency in information between primary and secondary packaging labels is a pitfall. This will lead to confusion, safety risks, and audit failures.

Best practices for ensuring medical device labelling compliance

We have recommended some best practices for medical device labelling compliance. A strategic and detail-oriented approach that aligns with international standards will be required.

• Tailor medical device labels for each regional market: Medical device labelling is not a one size fits all situation. It has to be tailored per the requirements of each regulatory authority, such as FDA, EU MDR, CDSCO, Health Canada, etc.
• Implement robust label review and approval workflows: Use cross-functional teams to validate the medical device label content. Additionally, maintain version control and audit trails for all label changes. Furthermore, conduct regular internal audits of labels and packaging
• Ensure accurate translations for regional markets: Translate IFUs and medical device labels into official languages of the target markets. Moreover, validate translations with certified linguistic services.
• Label should be durable: Design labels for durability and environmental resistance. Moreover, select label materials that withstand sterilization, humidity, and temperature fluctuations. Additionally, test label adhesion and legibility over the product’s lifecycle.
• Integrate UDI and traceability systems: Include both human-readable and machine-readable UDI formats in the medical device label. Ensure traceability from manufacturing to post-market surveillance.
• Maintain label consistency across all components: Ensure consistency in information across primary labels, secondary labels, IFUs, packaging, and e-labels. Avoid discrepancies that could lead to regulatory non-compliance or user confusion.
• Update labels with regulatory changes: Keep track of changes in labelling regulations. Keep your medical device label updated accordingly. Use labelling software that allows rapid updates across product lines. Implement global change control systems for medical device label guideline updates.
• Support electronic labeling (e-labels) where permitted: For devices used in hospitals or clinical settings, provide digital access to IFUs. Ensure e-labels meet accessibility and data integrity standards.
• Conduct periodic label audits: Schedule internal audits for the medical device labels to verify ongoing compliance. Include checks for outdated content, missing symbols, and regulatory alignment.
• Impart training: Educate staff on medical device labelling guidelines, regional regulations, labeling standards, and change control procedures.
• Use standardized label templates: Use globally accepted standardized medical device label templates as per ISO 15223-1 guidelines.
• Maintain digital archives: Maintain digital archives for label versions and approvals.
• Post-market feedback: Monitor post-market feedback for medical device label-related issues.
• Hire experts: Regulatory affairs experts have in-depth expertise of medical device labelling guidelines. An expert will guide you through the labelling process and ensure your label complies with the labelling guidelines.

Using technology to comply with device labelling guidelines

Technology can be used to automate medical device labelling processes. It will reduce human error, ensure consistency, and maintain audit trails. Moreover, it helps maintain accuracy, efficiency, and traceability of medical device labels. Here is how technology can help you:

• Automate labeling systems
• Generate regulatory compliant medical device labels using region-specific guideline templates
• Auto-populate UDI and serial data
• Validate label layout, format, and font size
• Synchronise labeling data with product lifecycle and quality systems
• Real-time device label change and approval tracking  

In short, by using a device labelling software, you can stay fully compliant with medical device labeling regulations in all markets.

Medical device labels should be informative and universally recognizable. Clear and easily understandable labels will help healthcare professionals and patients to correctly use and handle the device. As they contribute to patient outcomes and safety, medical device labelling guidelines are in place. The guidelines are focused on patient safety and effective and efficient healthcare delivery. They facilitate effective communication between manufacturers and patients as well as healthcare providers. Need help understanding device labelling guidelines? Shoot your queries at [email protected] or call/Whatsapp on 9996859227.