The EU MDR continues to evolve and so do its implications for labeling and artwork. The European Commission’s latest update (August 2025) revises national EU MDR labeling requirements, this time focusing on Portugal. While this may seem like a small change, it highlights a much bigger challenge for global manufacturers: keeping pace with shifting, country-specific rules across Europe.

What’s Changed in The Latest EU MDR Update?

• Portugal now requires Portuguese for all core documentation, including labels, IFUs, and implant cards.

• English may still be used for professional users or GUI interfaces, but only under strict conditions:

            - Portuguese IFUs must still be available (including translations of any GUI content). 
           - No evidence of incidents or complaints linked to English-only usage can exist.

This follows earlier updates for France (2024) and Romania (2024), demonstrating that EU MDR regulations, particularly around language, are constantly being refined.

What Do Manufacturers Need to Do 

For manufacturers, this isn’t just a translation issue, but a compliance and risk management challenge:

• Multiple regimes to track: Each EU Member State can enforce its own language rules under EU MDR regulations.
• Digital touchpoints included: GUIs, apps, and digital instructions are all subject to EU MDR labeling requirements.
• Risk of non-compliance: Missteps can mean rejected submissions, product recalls, or reputational damage.

In practice, this means labeling and artwork processes must go beyond static packaging — they need to be dynamic, multi-language, and fully auditable.

How Kallik's Cloud-Based, End-to-End Labeling and Artwork Software Can Help

Kallik’s Veraciti is designed for exactly this type of regulatory complexity. By providing a centralized source of truth for all label content across countries and languages, it ensures consistency and control. Its automated workflows apply country-specific EU MDR labeling requirements directly to artwork, labels, IFUs, and GUIs, removing the risk of manual error. At the same time, Veraciti delivers audit-ready compliance with full version control and traceability for every language update, giving manufacturers the confidence that nothing is overlooked. And when national provisions shift under EU MDR regulations, Veraciti enables fast, accurate updates across entire product portfolios, allowing companies to stay ahead of change rather than scrambling to catch up.

The EU MDR will continue to evolve, and language requirements are just one piece of the puzzle. As more countries refine their expectations, organizations without a robust system will face rising costs, slower approvals, and higher compliance risks. With Veraciti, you don’t just react to new and updated regulations; you stay one step ahead. 

Want to Know More About the Leading Labeling and Artwork Software Recommended by Gartner?

Here at Kallik, our experts are here to help businesses stay ahead of the curve, building labeling and artwork processes that are agile, compliant, and future-ready. Get in touch with us today by emailing enquiries@kallik.com or calling +44 (0) 1827 318100. Alternatively, click here to contact us and see what our software can do for your business. Want to stay up to date with all the latest industry news to keep ahead of regulatory changes? Scroll to the bottom to sign up for our bi-monthly newsletter to get all the info you need, directly in your inbox!

When it comes to medical devices, label accuracy is far more than an operational detail, it’s a critical compliance issue. Whether you're printing Instructions for Use (IFUs), applying Unique Device Identification (UDI) codes, or updating labels to reflect the latest EU MDR requirements, even a minor error can result in costly recalls, rejected batches, or serious risk to patient safety. And yet, many manufacturers still rely on outdated or manual processes for artwork comparison and approval, making it all too easy for issues to slip through the cracks.

It’s clear that technology needs to play a bigger role. With the right tools, teams can detect even the smallest differences between versions in seconds, giving them the clarity and confidence they need to make fast, informed decisions. That’s exactly what Veraciti’s comparison tool is designed to do. By automating the review process and integrating it directly into your labeling workflows, it removes the guesswork, reduces risk, and dramatically speeds up approval times.

Why Label Comparison is Critical in Medtech

Medical device labeling is uniquely complex. Regulations evolve constantly, requiring companies to update and revalidate thousands of label files. New market entries often mean changes to language, safety icons, and formatting, while changes to IFUs or product specs ripple through an entire library of associated content.

The consequences of getting it wrong are steep. Regulators demand evidence of control over your labeling process, especially when audited under EU MDR, IVDR, or FDA UDI requirements. Translation errors, misaligned formatting, or incorrect safety statements can put patients at risk and lead to non-compliance.

Yet, manually comparing PDF files or sending labels back and forth between departments is still common practice. It’s slow, it’s risky, and it’s not scalable.

How Veraciti’s Comparison Tool Makes a Difference

Built for regulated industries like medical devices, the tool allows users to compare different versions of the same label, alternate assets from within the Veraciti asset manager, or even files uploaded from a local device. This means users can review artwork created externally, such as IFU drafts from a design agency, without having to first add them into your system.

The comparison itself is a pixel-to-pixel check, meaning it detects even the smallest visual change. A report is then generated, clearly highlighting where differences exist, complete with ID numbers and side-by-side views of the master and sample artwork. This level of clarity not only speeds up approvals but also ensures traceability—something that’s essential for audit readiness.

What sets Veraciti’s comparison tool apart is how it integrates into day-to-day operations. The tool is embedded directly into the approval workflow. Once logged in, users can launch a comparison from within an approval task, adjust sensitivity settings, and generate a report within seconds. That report can then be saved directly to the asset manager, categorized under the appropriate subtype, and managed like any other regulatory record. This makes compliance easier to achieve and simpler to demonstrate–a true gamechanger for businesses in highly regulated industries.

Built for Speed. Designed for Compliance.

For medical device manufacturers, the benefits are immediate. Teams can catch errors before they reach production, speed up global approvals, and reduce manual effort—all while maintaining complete visibility over every change made. In a high-stakes, fast-moving industry, this isn’t just a process improvement—it’s a strategic advantage.

Want to see the difference for yourself?

Want to find out how you can streamline your artwork reviews and reduce approval times from hours to minutes. With Kallik, the future of labeling and artwork management is here, and it’s faster and easier than ever before. Don’t let outdated software hold you back. Want to know more? Speak to one of our experts on +44 (0) 1827 318100 or enquiries@kallik.com.

The world of labeling and artwork management is undergoing a major transformation. What Gartner has coined as the “Upgrade Cycle” in their recent supply chain packaging report represents a critical moment for businesses, especially in highly regulated industries, to re-evaluate and modernize their labeling and artwork management systems. The driver? A perfect storm of increasing regulatory complexity, mounting business risk, and rapid advancements in cloud and AI technologies.

At Kallik, we believe this isn’t just an upgrade cycle. It’s a wake-up call. And Veraciti™, our cloud-based, AI-powered labeling and artwork management platform, is built precisely for this moment.

The Upgrade Cycle: What’s Driving It?

Gartner highlights several key forces behind this shift, and all of them point to the need for modern, integrated, and intelligent platforms.

Tightening Regulations & Compliance Risk

With the recent EU Packaging and Packaging Waste Regulation (PPWR) and revised Classification, Labelling, and Packaging (CLP) laws, its clear now more than ever that the global regulatory landscape is in constant flux, and as a result, manual and fragmented labeling processes leave companies dangerously exposed. As Gartner warns, “Mismanaged labeling and artwork processes can lead to costly recalls and regulatory fines.” It’s crucial to be prepared to make mass changes to your labels at any moment

The solution? Centralized control, versioning, and automated workflows that ensure that changes can be made quickly and easily while remaining compliant, accurate, and audit-ready across global markets.

Cloud, Artificial Intelligence & Machine Learning Are No Longer Optional

According to Gartner’s 2025 Top Trends Transforming Supply Chain Packaging Strategies, “By 2028, the label and artwork management market will be dominated by a small handful of vendors who have mastered cloud, machine learning and AI capabilities.”

By choosing a cloud-native platform that seamlessly integrates AI and machine learning, businesses can completely transform their process for the better. In the long run, businesses can expect to save hundreds of thousands to millions of dollars, as well as large reductions in production times.

Efficiency Is a Major Competitive Differentiator

Speed to market has never been more critical — and outdated systems are a bottleneck. Gartner emphasizes the business case for change: “Technologies and software suites in the labeling and artwork management market have rapidly advanced... enabling a robust ROI once fully implemented.”

By automating the creation, approval, and deployment of labels and artwork across product lines and geographies, businesses can slash time-to-market while reducing the risk of human error. That means faster launches, lower costs, and greater agility.

End-to-End Data Integrity & Traceability

Accurate, consistent labeling depends on more than just smart design tools — it demands integration with master data and product lifecycle systems. Veraciti™ connects the dots, ensuring traceability from source data through to final print, enhancing both compliance and quality control.

Why Choose Kallik And Why Now?

Gartner’s insights clearly show where the labeling and artwork management market is heading. Veraciti™ was built not just to keep up with trends, business targets and ever-changing regulations, but to lead. With one, single end-to-end platform, everything you need is in one place – all stored securely and reliably in the cloud, where it can be accessed from anywhere in the world. So that means, no need to manually install and update multiple pieces of software on your computer. We manage the updates on our end, using the extremely reliable AWS to prevent downtime and keep you working 24/7 no matter where you are in the world.

We specialize in serving complex, highly regulated sectors like pharmaceuticals, medical devices, chemicals, cosmetics, and manufacturing, where precision, traceability, and compliance are non-negotiable. With the power of automation and AI at your fingertips, Veraciti will significantly minimize manual input, not only making your labeling and artwork process more efficient, but also eliminating the risk of errors.

Veraciti™ is constantly evolving alongside the latest regulations, trends and technologies. Choosing Kallik today means staying ahead of what’s next, with a platform designed for long-term scalability and resilience.

The Bottom Line

The upgrade cycle is real, so don’t get left behind. Companies that hesitate to change risk falling behind, both in compliance and in competitiveness. As Gartner makes clear, the winners in labeling and artwork management will be those who act now and partner with vendors that have mastered the technologies shaping the future.

Your Partner for the Future

If you're ready to streamline your labeling processes, ensure global compliance, and future-proof your operations, let’s talk. Book a demo with our team today and see how Veraciti™ can transform your labeling and artwork management. Alternatively, speak to one of our experts on +44 (0) 1827 318100 or enquiries@kallik.com.

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.  

EU MDR labeling requirements

Under the EU Medical Device Regulation (MDR 2017/745), both the device label and its instructions for use (IFU) are legally regulated content, not just design elements — Annex I, Chapter III sets out exactly what has to appear and where.

At a minimum, the label must include:

• Manufacturer name, registered trade name or trademark, and address
• A Unique Device Identifier (UDI) carrier (barcode or data matrix plus human-readable text)
• Lot number or serial number, so the device can be traced
• The device’s intended purpose, if it isn’t already obvious to the intended user
• Sterility status, if applicable, and the method of sterilization
• Manufacturing date and, where relevant, a “use by” or expiry date
• Any special storage or handling conditions
• An indication if the device is single-use
• The CE marking, plus the Notified Body number where one was involved in conformity assessment
• Relevant warnings or precautions needed before use

The IFU carries a separate, broader set of obligations: intended purpose and intended user, performance characteristics, contraindications, warnings and precautions, what to do in the event of malfunction, and how to report serious incidents. For most devices, IFUs can now be provided electronically rather than only in paper form, under the EU’s e-IFU rules – but the conditions for when that’s permitted are specific, and getting them wrong is a common audit finding.

The practical challenge isn’t knowing the rule, it’s enforcing it consistently: the same UDI, lot number and warning language have to stay correct and in sync across every market variant, pack size and translation, every time a label changes.

Building a medical device labeling strategy

Getting one label right is a compliance task. Getting every label right, across every market, product line and regulatory update, is a strategy – and it’s where most manufacturers start to feel the strain of manual processes.

A labeling strategy that scales usually addresses four things:

Single source of truth: Core content (manufacturer details, UDI structure, warnings, symbols) should live in one governed system, not be re-typed into each new label or IFU.

Market-by-market variation, controlled centrally: FDA, EU MDR, UKCA and other regional requirements overlap but aren’t identical; a strategy needs to manage those differences without creating separate, drifting versions of the truth.

Change control and traceability: When a regulation updates (as EU MDR requirements have continued to evolve since 2021), you need to know instantly which labels and IFUs are affected, and be able to prove what changed, when, and who approved it.

Review and approval workflows that don’t bottleneck launches: Regulatory, quality and brand sign-off all have to happen, but shouldn’t mean weeks of version-chasing over email.

Manufacturers who treat labeling as a system rather than a document-by-document task are the ones who can absorb a regulatory change or a new market launch without it becoming a fire drill.

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.

Sources:

• Medical Devices Labelling Requirements in the European Union
• MDR Labeling Requirements: A Comprehensive Guide for Medical Device Manufacturers
• Guide to Medical Device Printouts: Labels, IFUs and MDR Requirements
• MDR labelling requirements in the EU

As businesses look ahead to 2025, one of the most significant trends reshaping the labeling and artwork industry is the rise of electronic Instructions for Use (eIFUs). With increasing regulatory demands, technological advancements, and a growing emphasis on sustainability, eIFUs are fast becoming a key solution for companies aiming to streamline their processes, improve customer experience, and reduce their environmental impact.

What Are IFUs and eIFUs?

In the healthcare and medical device industries, Instruction for Use (IFU) documents play a critical role in ensuring the safe and effective use of products. Traditional IFUs are physical paper-based manuals or leaflets that accompany medical devices, providing essential information on their operation, maintenance, and safety precautions.

You might see one with a medical device like a glucose meter. The IFU would typically be a printed booklet or leaflet included in the packaging. It would provide essential information such as setup instructions, how to use the device properly, maintenance tips, troubleshooting guidance, and safety precautions. The IFU might also include diagrams or images to illustrate the steps clearly, ensuring users can effectively operate the device and understand its features.

However, with the rapid digitization of information, electronic Instructions for Use (eIFUs) are emerging as a modern alternative. eIFUs are digital versions of these instructional documents that can be accessed online or through electronic devices, offering advantages such as easier updates, reduced environmental impact, and enhanced accessibility for users worldwide.

An eIFU can take various forms, such as a downloadable PDF, an interactive web-based guide, or a mobile application which might be accessed by scanning a QR code on the product packaging or an NFC tag embedded in the product itself. These formats offer users easy access to comprehensive product information, ensuring they can efficiently utilize the product. For example, a medical device manufacturer might use an eIFU for a complex surgical instrument. Surgeons can access the eIFU via a secure app on their tablets, where they find step-by-step instructions, video demonstrations, and troubleshooting tips. This digital format allows healthcare professionals to familiarize themselves with the device before procedures, enhancing safety and efficacy in clinical settings.

How Do eIFUs Work?

eIFUs are designed to be easily accessible to end-users, whether they’re professionals in healthcare settings or general consumers. Here’s how they typically work:

Digital Hosting: Companies host eIFUs on secure, compliant platforms—often accessible via a simple website or through a mobile app.

Access Points: End-users can easily access the information by scanning a QR code, visiting a URL, or tapping an NFC-enabled device.

Version Control: Unlike printed documents that may become outdated, eIFUs can be updated in real-time, ensuring users always have the latest information without needing to reprint and redistribute materials.

Multilingual Options: eIFUs allow companies to provide multiple language options seamlessly, often reducing the complexity and cost associated with printing different versions for different markets.

The Benefits of eIFUs

The switch to eIFUs is not just about staying ahead of the technology curve—there are tangible benefits that can directly impact a company’s bottom line and sustainability initiatives.

Cost Efficiency: Printing, shipping, and storing physical IFUs are expensive processes. By going digital, businesses significantly reduce these costs, freeing up resources for other areas of development.

Enhanced User Experience: eIFUs offer a superior user experience, as they are always accessible and easy to navigate. With built-in search functions, users can quickly find the specific information they need, saving time and improving product usability.

Regulatory Compliance: Many industries, particularly healthcare, have stringent requirements for product labeling. eIFUs allow companies to ensure compliance with these regulations by providing real-time updates and version control, minimizing the risk of distributing outdated or non-compliant instructions.

Customization and Personalization: eIFUs can be tailored to individual users’ needs, offering additional information or guidance based on specific use cases. This level of customization is difficult to achieve with printed materials but is easily manageable in a digital format.

eIFUs: A Powerful Tool for Sustainability

Sustainability is no longer just a buzzword—it’s a core business priority. Companies across industries are striving to meet ambitious sustainability goals, and eIFUs are playing a key role in this effort.

Reduced Paper Waste: Traditional IFUs often run multiple pages and are included with every product, generating significant amounts of paper waste. Switching to digital formats cuts down on this waste, aligning with broader corporate sustainability goals.

Lower Carbon Footprint: By eliminating the need for printing and shipping physical documents, companies reduce their carbon emissions. The process of producing and distributing printed materials requires substantial energy and resources, from paper production to transportation.

Minimized Resource Use: eIFUs require fewer resources overall, from raw materials (like paper and ink) to the energy used in the printing process. This resource minimization is crucial as businesses aim to reduce their environmental impact and move toward more circular, sustainable practices.

Why eIFUs Will Dominate in 2025

As we move toward 2025, eIFUs are poised to become one of the biggest trends in labeling and artwork management. The combination of regulatory demand, technological ease, and a global shift toward sustainability means more companies will be adopting this digital-first approach to product labeling. The healthcare and pharmaceutical sectors are already leading the charge, but industries ranging from consumer electronics to cosmetics are quickly recognizing the advantages.

Moreover, the increasing adoption of cloud-based systems, AI, and automation in labeling and artwork management will make the creation, distribution, and management of eIFUs even more efficient. Solutions like Veraciti, with its AI-powered automation tools, are making it easier than ever to integrate eIFUs into existing systems, ensuring businesses can stay ahead of the curve while also meeting sustainability objectives.

Get Ahead of the Curve

eIFUs are not just a fleeting trend; they represent a fundamental shift in how businesses approach product labeling. With their cost-saving, user-friendly, and sustainable benefits, eIFUs are set to redefine the labeling and artwork landscape in 2025 and beyond. Companies that embrace this transition will not only be meeting regulatory requirements and enhancing customer experience—they’ll also be playing their part in building a more sustainable future.

Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100. Alternatively, click here to book a demo and discover how a cloud-based, end-to-end solution can simplify your process, ensuring accuracy, compliance, and efficiency from start to finish.

With tomorrow being Halloween, it's the perfect time to talk about some real-life labeling and artwork "horror stories" that have left companies facing consumer nightmares and costly recalls. But don’t worry—there’s no need to scream in terror! We’ll also explore how you can avoid these frightful errors by implementing end-to-end, cloud-based, automated solutions to keep your processes smooth and compliant.

Here are five real-life cautionary tales of companies who fell victim to labeling errors—and how they could have been avoided with the right technology:

1. Pharmaceutical Dosage Disaster

In 2003, Pfizer faced a major issue with the hormone replacement therapy drug Prempro due to labeling problems that resulted in miscommunication about dosage and instructions. This labeling failure led to confusion among patients and healthcare providers, contributing to adverse health effects and subsequent legal actions. The incident eventually culminated in a large settlement, as Pfizer was accused of providing unclear or incorrect dosage details that heightened health risks for users, and the legal repercussions continued over the years as additional safety concerns related to the drug surfaced.

The legal battles Pfizer faced regarding Prempro included a larger settlement in 2011, amounting to over $330 million, when they resolved around 2,200 cases that alleged links between Prempro and increased risks of breast cancer. This case emphasized the serious consequences of inadequate labeling in the pharmaceutical industry, where even minor inaccuracies can lead to significant patient health risks and liability concerns for companies.

2. Leading Supermarket’s Allergen Labeling Fail

The 2015 Tesco allergen labeling incident involved a mislabeled batch of crisps that posed a serious risk to consumers with dairy allergies. A package of cheese and onion crisps was incorrectly labeled as salt and vinegar, omitting the presence of milk allergens. The oversight, part of Tesco's "Free From" range that caters to people with food allergies and dietary restrictions, exposed customers to potential allergic reactions, prompting the company to issue a recall and eventually resulting in a £300,000 fine from the Westminster Magistrates’ Court. The court emphasized the gravity of the incident, highlighting the responsibility of major retailers to ensure rigorous allergen labeling to protect consumers' health.

3. Cereal Manufacturer’s Peanut Residue Recall

In 2016, Kellogg’s recalled about 10,000 cases of its Keebler and Famous Amos cookies due to undeclared peanut residue. This oversight, traced to a flour supplier, posed serious risks to consumers with peanut allergies, who could suffer severe reactions from exposure. The affected products included several types of cookies, such as Keebler’s Animals Crackers and Famous Amos Double Chocolate Chip cookies. This widespread recall emphasized the importance of thorough allergen checks and clear labeling in the food industry. Although no illnesses were reported, the incident served as a strong reminder of the critical role accurate labeling plays in protecting consumer health​.

4. Frozen Meals Mislabeling

In 2017, Conagra Foods issued a significant recall on its Healthy Choice Power Bowls due to a dangerous labeling error. The meals, labeled as Korean-Style Beef, actually contained a chicken sausage and pepper product that included milk—an allergen not declared on the packaging. This posed a serious risk for those with dairy allergies, prompting the USDA to classify it as a Class I recall, indicating the potential for serious health consequences. Fortunately, no adverse reactions were reported before the recall went public​.

5. Packaging Pains at Leading Consumer Healthcare Manufacturer

In 2008, a leading consumer healthcare manufacturer recalled approximately 5 million bottles of its painkiller tablets. The recall was initiated after it was discovered that the labels failed to specify the presence of certain allergens, which could pose risks to individuals with allergies. The labeling error was significant enough to warrant a recall to prevent potential adverse health effects.

Labeling Nightmares Like These Can be a Thing of the Past with End-to-End Cloud-Based Solutions

Labeling mistakes like these happen when teams rely on disconnected, siloed processes or outdated manual checks. But it doesn’t have to be this way! AI and automation play a key role in preventing human error by flagging discrepancies and automatically checking regulatory compliance. Meanwhile, cloud-based platforms mean better collaboration—no more passing around versions via email and risking outdated or incorrect artwork slipping through the cracks. Ultimately though, it’s all about using an end-to-end solution, eliminating siloes and communication issues between stakeholders. By managing the entire process in one single solution, you are greatly reducing the risk of errors in your labeling and artwork, something which could not only save a lot of money, but also potentially save lives.

Key Benefits of End-to-End Cloud-Based Software:

AI-Backed Automation: Automated checks and regulatory compliance built into the process prevent costly human errors.

No Silos: A centralized platform allows all teams, from regulatory to marketing, to collaborate in real-time, ensuring the correct version of labels and artwork is used.

Version Control: Every update is tracked, and no outdated versions are used.

Real-Time Collaboration: Cloud-based systems allow teams across different locations and time zones to work together seamlessly.

Kallik’s Veraciti: Your Savior from Labeling Nightmares

At Kallik, our Veraciti platform does all this and more. Built specifically for labeling and artwork management, Veraciti ensures regulatory compliance, streamlines processes, and prevents costly errors. With AI-backed tools and end-to-end cloud-based workflows, Veraciti keeps your teams in sync, your artwork flawless, and your labels always accurate.

This Halloween, don’t let your labeling process turn into a horror story—equip your team with the tools they need to succeed. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100. Alternatively, click here to book a demo and discover how a cloud-based, end-to-end solution can simplify your process, ensuring accuracy, compliance, and efficiency from start to finish.

Traceability is more than just a buzzword in the medical device industry—it's a vital component of regulatory compliance, operational efficiency, and ultimately, patient safety. At Kallik, we understand the critical role that robust traceability plays in ensuring patient safety, meeting regulatory requirements, and enhancing supply chain transparency. This blog explores the importance of traceability, the role of emerging technologies in enhancing it, and how advanced solutions like Kallik’s Veraciti™ are setting new standards in the industry.

The Crucial Role of Traceability in Medical Devices

Traceability in the medical device sector involves tracking every stage of a product's lifecycle—from development and manufacturing to distribution and usage. This meticulous tracking ensures that each device can be accurately identified and traced back through its supply chain, which is essential for several reasons:

Patient Safety: Traceability helps in promptly identifying and recalling faulty devices, thereby protecting patients from potential harm.

Regulatory Compliance: Regulatory bodies, such as the FDA in the U.S. and the European Medicines Agency (EMA) in Europe, require stringent traceability standards to ensure that all medical devices meet safety and efficacy requirements.

Supply Chain Efficiency: Effective traceability can streamline the supply chain, reducing errors and improving coordination among stakeholders.

The European Union’s Unique Device Identifier (UDI) system, mandated in 2020 for medical devices and 2022 for in vitro diagnostic devices, highlights the growing importance of traceability. Despite delays in the implementation of the EUDAMED database, the push towards comprehensive traceability remains strong, underscoring its significance in the industry.

The Role of Digitalization in Enhancing Traceability

Digitalization is transforming traceability in the medical device industry by breaking down traditional silos and creating a more integrated, transparent supply chain. By digitalizing various stages of the supply chain, manufacturers can achieve significant improvements in efficiency and visibility.

Cultivating Consistency

Life sciences supply chains are highly complex, involving multiple tiers of suppliers and wholesalers. Digitalization helps cultivate consistency across these complex networks. A key element in supply chain optimization is having a single source of content that is consistent throughout the ecosystem. This "single source of truth" can be a statement, symbol, image, or a combination, approved as the definitive version. With digitalization, this master source can be seamlessly integrated into every stage, from product development to customer fulfillment, ensuring everyone is using the latest, accurate content.

Ensuring Interoperability

For global traceability, digitalization ensures that labeling content meets local regulatory requirements and broader regional mandates. This includes accommodating local safety statements, symbols, and translations. A centralized digital system can trace all labels back to the original master source, maintaining integrity and clarity for local readers. This global interoperability is crucial for end-to-end traceability, giving organizations complete visibility of label content across all markets.

Addressing Organizational Challenges

Implementing a harmonized system for positive identification of medical devices is more of an organizational challenge than a technical one. Digitalization can overcome these challenges by establishing clear data governance and ownership. It ensures that the right stakeholders are responsible for decisions about changes and updates to labeling, critical for meeting local market requirements and maintaining compliance.

Enhancing Decision-Making and Collaboration

Digitalization also improves decision-making and collaboration within the supply chain. By integrating systems and data, stakeholders can operate more seamlessly and collaboratively. Regulatory, marketing, and manufacturing teams, as well as third-party partners, can access the same system overseeing the master content, allowing for efficient updates, modifications, and reviews. This enhanced collaboration ensures that everyone is working with the most up-to-date and accurate information.

Strengthening Supply Chain Infrastructure

Visibility across the supply chain is essential for effective traceability. Digitalization ensures that an authoritative master copy of the content for each label is easily identifiable and accessible throughout the process. This prevents the use of outdated symbols or statements and ensures compliance with traceability requirements. It provides real-time visibility of the most recently approved content and details of who approved it and when.

Overcoming Digitalization Challenges

Transitioning to a digitalized labeling management system can be challenging, especially when existing content is in non-editable formats like PDFs, printed documents, or emails. However, digitalization involves making content available at an atomic level, breaking it down into specific elements such as phrases, statements, or symbols. These elements can then be reconstructed and reused to create accurate new labeling, ensuring consistency and compliance.

How Veraciti™ Sets New Standards in Traceability

While many companies are leveraging emerging technologies to improve traceability, Veraciti™ stands out for its comprehensive and innovative approach. Veraciti™ offers a unique set of features that differentiate it from competitors, providing the best possible traceability solutions for the medical device industry.

1. Centralized Content Management

Veraciti’s centralized content management system ensures that all labeling and packaging content is consistent and up-to-date across the entire supply chain. This centralization eliminates silos, ensuring that every stakeholder has access to the latest, approved content, thereby reducing errors and improving compliance.

2. Global Interoperability

Veraciti™ is designed to meet local regulatory requirements while maintaining global interoperability. The platform supports multiple languages and regional mandates, ensuring that labeling content is accurate and compliant worldwide. This global approach ensures that every device can be traced back to a single source of truth, providing complete visibility and traceability.

3. Enhanced Collaboration

Veraciti™ facilitates seamless collaboration among all stakeholders, including regulatory, marketing, and manufacturing teams. By providing a single platform for managing content, Veraciti ensures that all parties can update, review, and approve content efficiently. This collaborative approach extends to third-party partners, ensuring an integrated and transparent supply chain.

4. Real-Time Visibility

Veraciti™ offers real-time visibility into the supply chain, ensuring that all activities are transparent and traceable. This visibility is crucial for maintaining compliance and quickly responding to potential issues. By providing detailed insights into the entire supply chain, Veraciti™ helps companies maintain high standards of traceability.

5. Future-Proof Solutions

Veraciti™ is designed with the future in mind, supporting the ongoing digital transformation of the medical device industry. The platform’s robust architecture and advanced features ensure that it can adapt to evolving regulatory requirements and technological advancements, providing a future-proof solution for traceability.

Leading the Way For Maximum Traceability

In an industry where traceability is paramount, digitalization is reshaping how companies track and manage their products. By breaking down silos and creating a more integrated supply chain, digitalization enhances consistency, interoperability, and collaboration. 

Veraciti™ is leading the way in the industry by leveraging these advancements to offer a comprehensive, future-proof solution that sets new standards in the medical device industry. By focusing on centralized content management, global interoperability, enhanced collaboration, and real-time visibility, Veraciti™ ensures that companies can achieve the highest levels of traceability and regulatory compliance.

Speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business thrive in a rapidly changing regulatory environment. 

Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.

With regulations changing and tightening constantly and consumer demands shifting with a heightened focus on sustainability, it's no wonder that artificial intelligence (AI) and automation are taking the labeling and artwork world by storm. 

The digital transformation in labeling and artwork management is well underway and throughout 2024 so far we've seen a huge focus on innovation in AI and automation. Let's look at the benefits of AI and automation in artwork and labeling software and the risks of being left behind if organizations fail to digitize their processes. 

The AI Revolution in Labeling and Artwork Management

Artificial Intelligence (AI) is no longer a futuristic concept; it’s a reality that is transforming the way businesses manage their labeling and artwork processes. AI’s capabilities in data analysis, predictive maintenance, and process optimization are proving to be game-changers.

How AI is Affecting the Industry:

Data Accuracy and Consistency:
AI algorithms can analyze vast amounts of data with unprecedented accuracy. This ensures that labels and artwork are consistent across all products and regions, reducing the risk of errors and non-compliance.

Predictive Analytics:
AI-powered predictive analytics can forecast market trends and regulatory changes, enabling companies to stay ahead of the curve. This foresight helps in proactive label and artwork management, ensuring timely updates and compliance.

Personalization:
AI allows for the creation of highly personalized labels and artwork tailored to specific consumer segments. This targeted approach can enhance customer engagement and brand loyalty.

The Automation Advantage

Automation is another key trend that is streamlining the labeling and artwork management process. By automating repetitive and time-consuming tasks, companies can achieve greater efficiency and accuracy.

How Automation is Affecting the Industry:

Workflow Optimization:
Automation tools streamline the workflow from design to approval, reducing the time required to bring new products to market. Automated processes eliminate bottlenecks and ensure smooth transitions between stages.

Cost Efficiency:
By reducing manual labor and minimizing errors, automation significantly cuts operational costs. Companies can reallocate resources to more strategic tasks, driving innovation and growth.

Regulatory Compliance:
Automated systems can be programmed to adhere to the latest regulatory standards, ensuring that all labels and artwork comply with industry regulations. This reduces the risk of costly compliance issues and product recalls.

The Risks of Not Adopting AI and Automation

The risks of not keeping up with AI and automation are substantial and could see your business left behind very quickly. During Kallik’s recent webinar, held in partnership with the Regulatory Affairs Professionals Society (RAPS), Gartner's John Blake discussed the importance of composability brought about by this digital transformation, likening it to the evolution of the compact disc. “I would have to go find the music I want to put on a CD, I’d have to find a blank CD and I’d have to find a CD burner. I’d then have to mail a physical copy out too. So quite honestly, that would probably take about two weeks to do. But with the introduction of streaming services, which is also digital music, it's composable. I could give you the name of a song or an artist, I wouldn't even have to spell it correctly, and you could find it and be listening to it in seconds,” John highlights the power of digitalization.

He went on to summarize, “We need to think about this in our business processes. We need to think about how we manage and utilize technology to really improve our processes around artwork and labeling. And certainly, that has benefits in the regulatory space.” The benefits in terms of regulatory compliance and efficiency are profound and should not be overlooked. Companies that fail to embrace these technologies may face:

Increased Errors and Non-Compliance:
Without AI and automation, manual processes are prone to errors, leading to non-compliance with regulatory standards. This can result in significant financial penalties and damage to brand reputation.

Higher Operational Costs:
Manual labeling and artwork management are labor-intensive and costly. Companies that do not automate these processes will find it challenging to remain competitive in terms of pricing and efficiency.

Slower Time-to-Market:
In a fast-paced market, speed is crucial. Companies relying on outdated manual processes will struggle to keep up with competitors who have streamlined their operations with AI and automation.

Why Choose Kallik:

Compliance Assurance:
Our AI-driven solutions ensure that your labels and artwork are always compliant with the latest regulatory standards, minimizing risk and ensuring peace of mind.

Cost and Time Efficiency:
By automating workflows and utilizing AI, we help our clients achieve significant cost savings and faster time-to-market, providing a competitive edge in a crowded market. Speak to one of our experts about our AToM (Assisted Technology of Migration) technology, developed in partnership with Aston University and driven by AI to significantly streamline and simplify the migration process.

Expert Support:
Our team of experts is dedicated to helping you navigate the complexities of labeling and artwork management. We offer personalized support to ensure you get the most out of our innovative solutions.

Want to know more?

The labeling and artwork management industry is undergoing a transformative shift, driven by AI and automation. Companies that embrace these technologies stand to gain significant advantages in terms of compliance, cost efficiency, and speed. At Kallik, we are proud to lead the way in this technological revolution, providing our clients with the tools they need to stay ahead of the competition. Don’t risk falling behind—partner with Kallik and embrace the future of labeling and artwork management today. Speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business thrive in a rapidly changing regulatory environment. 

Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.

When it comes to pharmaceuticals and medical devices, regulatory compliance stands as a cornerstone of patient safety and well-being. Yet, ensuring compliance with evolving standards and regulations poses significant challenges for organizations worldwide. Traditional methods of producing Instructions For Use (IFUs) and Patient Information Leaflets (PILs) have often proven inadequate in meeting these demands.

These documents serve as crucial sources of information for patients, providing guidance on the proper use of medical devices and medications. Inaccuracies or errors in these leaflets can have severe consequences. When it comes to pharmaceutical and medical device labeling, the risks can even be life-threatening.

Therefore, ensuring the accuracy and compliance of patient information and instructions for use leaflets is essential for safeguarding patient health and maintaining regulatory adherence. However, with the introduction of automation in the labeling and artwork industry, a new era of efficiency, compliance, and accuracy has arrived in IFU production.

Addressing Regulatory Gaps

As Bob Tilling, our label and artwork expert, highlights, regulatory compliance is crucial. Mid-sized device manufacturers often have to manage between 100 and 1,000 IFUs. Updating these documents to comply with the new EU Medical Device Regulation (EU MDR), which is significantly longer and more detailed than the previous directive, is a massive task.

Non-compliance with EU MDR labeling requirements not only puts patients at risk but also exposes organizations to legal repercussions and reputational damage. Traditional systems, including Product Lifecycle Management (PLM) systems, often fall short in controlling layout and content. Veraciti emerges as a beacon of hope, offering a comprehensive solution that not only manages content but also controls layout, ensuring compliance with regulatory standards.

Streamlining Processes, Eliminating Errors

The traditional approach to IFU production involves input from several stakeholders across the globe, consuming time and increasing the risk of errors. Veraciti revolutionizes this process by automating the generation of leaflets from a pre-approved single source of truth with automatic translations available, eliminating the need for manual intervention when creating and updating the leaflets.

Breaking Language Barriers, Ensuring Consistency

For IFU leaflets, it's crucial that the information can be correctly understood by patients and healthcare professionals worldwide. Veraciti enables organizations to swiftly generate IFUs in multiple languages within seconds. Unlike competitors who rely on less accurate methods like Google Translate, Veraciti offers pre-approved translations derived from a single source of truth, ensuring consistency and accuracy across all IFUs. This capability is a game-changer, empowering non-native speakers to access vital medical information with ease and confidence, ultimately contributing to improved healthcare outcomes globally.

Making the Move to eIFUs (Electronic IFU)

The transition from traditional paper-based IFUs to electronic formats marks a significant leap forward in efficiency and accessibility. Electronic IFU leaflets offer streamlined access, enhanced user experience, the ability to deliver multilingual content seamlessly, and significant sustainability benefits. With electronic IFUs, the process of updating information is far less time-consuming and involves less waste.

As Peter Muller explains in Med-Tech Intelligence, "Paper-based IFUs/PILs are printed in bulk, leading to waste when product/manufacturing information or safety advice needs to be updated. There may also be a level of risk to patients if they are accessing information that has been superseded."

Veraciti empowers organizations to generate IFUs in electronic formats, including XML files, ensuring compliance with regulatory standards while enhancing accessibility and integration. This capability enables organizations to navigate regulatory complexities with ease while delivering an unparalleled user experience.

Case Studies: Empowering Össur and Cardinal Health

Our collaboration with Össur, a leading provider of Class II medical devices, exemplifies the transformative impact of automation in IFU production. Össur faced numerous challenges, including disparate legacy systems, delays in product launches, and limited control over IFU assets. With Veraciti, Össur consolidated IFU phrases into a centralized system, enhanced visibility, and streamlined the approval process, ensuring compliance with regulatory requirements.

Similarly, our partnership with Cardinal Health, a global leader in healthcare services, highlights the critical importance of accuracy and compliance in IFU production. By streamlining the compliance process and eliminating errors, we have helped Cardinal Health navigate the complexities of regulatory standards, particularly in the context of MDR compliance.

Safeguarding Lives, Ensuring Compliance

By adopting our approach, the creation of multiple language EU MDR compliant 30-page IFUs has been reduced from 3-5 hours to just 30-40 minutes, with the time taken to generate individual labels reducing from 1 hour to around 10 minutes. For Class III devices alone, this efficiency has recovered 5 person-years of lost time.

In conclusion, automation in IFU production is a game-changer for compliance, accuracy, and efficiency. By leveraging the power of technology, organizations can streamline processes, eliminate errors, and ensure compliance with regulatory standards. Our partnerships with Össur and Cardinal Health underscore our commitment to empowering organizations with complete regulatory confidence.

For more information on the latest EU MDR and the issues with IFUs, read our blog: "EU MDR Labeling Compliance - Are We There Yet?" Looking for more advice? Speak to one of our experts by emailing enquiries@kallik.com.