Today’s global and digital economy depends on clear product identification and easy information sharing. For regulated industries such as pharmaceuticals, medical devices, and cosmetics, this isn’t just about efficiency, but also patient safety, compliance, and trust. That’s where GS1 standards come in, so let's break down what they are, why they matter and how they affect labeling and artwork management.

Understanding GS1 Standards

GS1 is a global, not-for-profit organization that develops and maintains standards for business communication. Its most widely recognized standard is the barcode, but GS1 standards go far beyond that — they provide a universal language for identifying products, locations, assets, and logistics units throughout the supply chain.
Some of the most common GS1 identifiers include:

• GTIN (Global Trade Item Number): Identifies individual products or SKUs.
• GLN (Global Location Number): Identifies physical locations or legal entities (e.g., manufacturing plants, warehouses).
• SSCC (Serial Shipping Container Code): Identifies logistics units like pallets or cases.
• GS1 DataMatrix and QR Codes: Encode rich, structured data (such as expiry dates or batch numbers) in a compact format.

Together, these identifiers enable traceability, interoperability, and data accuracy across every participant in a global supply chain — from manufacturer to regulator to end user.

Why GS1 Standards Matter for Regulated Industries

In highly regulated sectors, the correct use of GS1 identifiers is a necessity for complete compliance and the safety of all involved. Here are some of the most important things to understand:

1. Ensuring Traceability and Patient Safety
Every product must be traceable from production to patient. GS1 standards underpin systems that track each unit’s journey, allowing for quick recalls, expiry management, and counterfeit prevention. For example, under the EU Falsified Medicines Directive (FMD) or the U.S. DSCSA (Drug Supply Chain Security Act), serialization using GS1 identifiers ensures that every package can be uniquely identified and verified.

2. Supporting Regulatory Requirements
Regulators across the world, including the FDA, EMA, and MHRA, endorse GS1 standards for labeling and serialization. Using GS1 data structures correctly is vital to meet UDI (Unique Device Identification) and pharmaceutical labeling mandates.

3. Driving Global Interoperability
Because GS1 standards are recognized globally, they simplify cross-border operations and ensure data consistency between trading partners, healthcare providers, and regulators. This is particularly important for multinational organizations operating under different regulatory regimes.

4. Reducing Risk Through Standardization
Using standardized identifiers minimizes the risk of labeling errors, which can have serious consequences — from product recalls to regulatory fines and, in worst cases, patient harm. GS1’s globally harmonized system ensures every product carries accurate, meaningful information.

The Role of Labeling and Artwork Management Software

Implementing GS1 standards demands robust systems and processes that manage product data, control artwork, and maintain compliance at every stage. This involves:

1. Data Integrity and Centralization
Modern labeling and artwork management platforms, such as Kallik’s, centralize master data and ensure that GS1 identifiers (like GTINs or GLNs) are accurate, validated, and consistently applied. This eliminates the risk of using outdated or incorrect codes during label design.

2. Automation and Rule-Based Compliance
Automation ensures that GS1 identifiers and barcode structures are applied correctly across thousands of SKUs. Rule-based workflows verify data at every stage, so compliance is baked into the process rather than checked after the fact.

3. Visibility and Auditability
Regulated industries must be able to demonstrate compliance during audits. A digital artwork and labeling system provides full version control, approval workflows, and audit trails, ensuring every label change can be tracked back to its source.

4. Adaptability to Change
As GS1 standards evolve (for example, the transition to 2D barcodes and GS1 Digital Link), flexible labeling systems allow organizations to adapt quickly without disrupting supply chains or re-engineering entire labeling templates.

The Bottom Line: Compliance Starts with Standards

GS1 standards are the foundation of trust and traceability in regulated industries. But compliance depends on the right tools to enforce them at scale. By integrating GS1 principles into labeling and artwork management software, organizations can ensure that every product label not only meets global regulatory requirements but also delivers on its ultimate purpose: protecting patients, consumers, and brands alike.

Interested in learning how Kallik helps organizations achieve complete regulatory compliance with zero errors and total consistency? Contact us here or check out our case studies to see real world examples of how we've helped some of the biggest global manufacturers.
 

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We’re currently running a short industry survey on labeling and artwork challenges for 2026, and we’d really appreciate your input! Your insights could help shape our upcoming 2026 industry report. If you can spare five minutes, take the survey and enter our draw for one of five $/£50 Amazon vouchers. 
 

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When it comes to medical device manufacturing, labeling accuracy and compliance are non-negotiable. As global operations expand and regulatory frameworks become more complex, manufacturers are increasingly turning to automated labeling systems to streamline processes, eliminate human error, and ensure global consistency.

This article explores the core benefits of implementing an automated labeling system across global manufacturing environments, and how it supports compliance with stringent regulations like EU MDR, FDA 21 CFR Part 11, and UDI labeling requirements.
 

1. Ensuring Global Compliance with Medical Device Regulations

Every medical device label must meet specific regulatory standards, and these vary across regions. Whether it’s UDI compliance in the United States, EU MDR labeling requirements in Europe, or ISO 13485 quality management systems, maintaining accuracy across geographies is a challenge for any manufacturer.

An automated labeling system ensures that compliance rules are built directly into the labeling process. This allows medical device companies to:

• Automatically apply region-specific labeling templates
• Maintain full audit trails for regulatory inspections
• Reduce noncompliance risk through controlled label versioning

With built-in validation and electronic signatures that align with FDA 21 CFR Part 11, an automated labeling system makes it easier to meet global regulatory obligations while minimizing manual intervention.

2. Improved Accuracy and Error Reduction

Manual labeling introduces risk. A single misprint or incorrect data field can lead to product recalls, compliance violations, and costly downtime. An automated labeling system eliminates these risks by integrating directly with master data systems such as ERP, MES, and PLM platforms.

By connecting to centralized data sources, automated labeling systems automatically populate variable data like lot numbers, expiration dates, and device identifiers. This removes the need for manual entry and ensures 100% accuracy every time a label is printed.

3. Accelerated Global Production and Time-to-Market

Label changes must often be executed quickly to respond to new regulations, product updates, or market launches. Automated labeling systems enable centralized label management, allowing updates to be deployed instantly across global facilities.

This then reduces label change cycles from weeks to just minutes, consequently accelerating approvals and helping manufacturers bring products to market faster. For medical device companies navigating multiple regions and product variations, an automated labeling system becomes an operational game-changer.

4. Enhanced Traceability and UDI Compliance

Traceability is critical in medical device labeling. The UDI (Unique Device Identification) system requires consistent and standardized labeling that enables rapid identification throughout the product lifecycle.

An automated labeling system can support this by:

• Generating UDI-compliant barcodes and data matrices automatically
• Integrating with device registration databases
• Providing instant access to complete label histories

This not only ensures compliance with FDA UDI and EU MDR but also strengthens internal quality control and post-market surveillance.

5. Reduced Costs and Operational Efficiency

By removing manual tasks and minimizing rework, automated labeling systems reduce operational costs across the production line. They streamline label design, approval, and printing, all while maintaining compliance and consistency across global sites.

When deployed at scale, an automated labeling system drives measurable ROI through:

• Decreased downtime from labeling errors
• Reduced waste from misprinted labels
• Simplified IT maintenance and validation processes

In short, automation transforms labeling from a compliance burden into a strategic advantage.

6. Future-Proofing Through Scalability and Integration

As the global medical device industry continues to evolve, manufacturers need labeling systems that can scale and adapt. Modern automated labeling systems are built with flexibility in mind, integrating seamlessly with digital ecosystems and cloud-based architectures. This means future updates, such as new barcode standards, multi-language labeling, or expanded UDI regulations, can be implemented quickly without disrupting operations.

Final Thoughts

For global medical device manufacturers, labeling is crucial for operational integrity and brand trust. By implementing a robust automated labeling system, organizations can ensure accuracy, accelerate production, and maintain compliance across every market.

As regulatory scrutiny increases and supply chains become more complex, automated labeling systems provide the control, scalability, and transparency manufacturers need to stay ahead. And if you’re considering making the change but aren’t sure where to start or feel unprepared, you can download our latest ebook on getting into the mindset for digital transformation here.  Alternatively, speak to one of our labeling and artwork experts to learn more about what Veraciti™ can do for your business, by calling +44 (0) 1827 318100 or emailing enquiries@kallik.com.

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At Kallik, we pride ourselves on staying close to the challenges, conversations, and innovations shaping the future of labeling and packaging. That means more than just keeping up with industry news, but being part of the dialogue.

In recent weeks, two of our team members represented Kallik at major industry events: Kallik’s Chief Delivery Officer, Beth Peckover, attended the 14th Pharma Packaging and Labeling Innovation Forum in Berlin, while Senior Vice President of Sales, Sharad Khusal, joined the virtual Q1 Productions 16th Semi-Annual Medical Device & Diagnostic Labeling Conference.

Both events offered a wealth of insight into where the pharmaceutical and medical device sectors are heading and what that means for labeling, artwork, and packaging operations. Below, we recap the major themes that emerged and look at how to stay one step ahead.

The Big Talking Point: ePI and the Digital Transformation of Labeling

One of the most prominent topics at the Berlin forum was electronic Product Information (ePI). As Beth shared, ePI was the subject of multiple discussions and presentations, and it’s clear why.

ePI represents the digital evolution of medical information, where product leaflets, patient information, and label content are made available electronically, typically via QR codes or online portals. The European Medicines Agency (EMA) is leading the way with pilot programs exploring how this digital approach can improve patient access, enable faster updates, and support more sustainable, paperless labeling.

While the concept may sound straightforward, the implications for labeling and artwork are significant. ePI requires content to be managed in structured, modular formats rather than as static documents. Every change, whether a dosage update or a new safety warning, needs to be reflected instantly across both printed and digital formats.

That demands a high level of content agility, data accuracy, and process integration. For artwork and labeling teams, this means rethinking how they manage product information: moving from manual updates to centralized, automated systems that ensure every label, leaflet, and QR code is perfectly in sync.

As the industry transitions toward digital-first product information, companies will need to strike a careful balance between compliance, accessibility, and user experience. At Kallik, we see this as a huge opportunity for organizations to modernize their labeling operations, reduce risk, and streamline updates, while ensuring the same quality and consistency across every channel.

Pharma Supply Chain Pressures and the Need for Agility

Another major theme Beth noted at the Berlin event was the growing challenge of supply chain disruption in the pharmaceutical industry. Shortages of key materials and ingredients are forcing companies to source from alternative suppliers at short notice.

That might sound like a procurement issue, but it has deep implications for packaging and labeling. When suppliers or components change, the product specifications often change too. This ultimately means labels and artwork must be adapted quickly to reflect new details, batch information, or manufacturing locations.

This is where agility in packaging and labeling becomes critical. Companies that rely on manual updates, spreadsheets, or disjointed approval processes risk significant delays, inconsistencies, and even compliance breaches.

The takeaway from the forum was clear: businesses need flexible, responsive labeling systems that can handle change efficiently. Whether that’s updating artwork across multiple SKUs or localizing information for different markets, agility must be built into the process and not bolted on as an afterthought.
Beth comments on this, “At Kallik, we’ve long emphasized the importance of flexibility. True agility in labeling comes from centralized data, automation, and digital collaboration, allowing changes to cascade instantly across all materials while maintaining full traceability and compliance.”

Medical Device Labeling: Integration, Security, and Global Flexibility

Meanwhile, over at the Q1 Productions event, Sharad found that the conversations around medical device labeling echoed similar themes of agility and digital maturity.

One key area of interest was interoperability: the ability for labeling content to integrate seamlessly with other systems. Delegates were particularly keen to understand how digital labeling solutions can support standardized data formats and integrations with enterprise systems such as PLM, ERP, and regulatory databases.

This reflects a growing recognition that labeling no longer operates in isolation. To achieve efficiency and compliance at scale, it must connect directly to the systems that feed it data to ensure a single, authoritative source of truth.

Sharad shares, “Following my presentation, I received questions about the types of label formats supported by modern labeling platforms, especially around flexibility and customization.” Many companies face the challenge of managing region-specific label variations to meet different country regulations and language requirements. This is why it’s crucial to use a platform that can handle this diversity while still maintaining consistency and control.

Another recurring topic was cybersecurity. As more labeling operations move to the cloud, delegates were rightly concerned about data protection, malicious attacks, and the safeguarding of intellectual property. The message from attendees was clear: labeling vendors must not only deliver flexibility and integration but also ensure that cloud-based environments meet the highest security standards.

A Clear Message: The Industry Wants Confidence and Control

Across both conferences, the common thread was unmistakable. Whether it’s ePI in pharma, supply chain agility, or digitized labeling in the medical device space, organizations are looking for confidence and control. They want systems that allow them to adapt quickly, maintain compliance, and collaborate securely without sacrificing quality or speed.

It’s encouraging to see the industry aligning around these priorities. As labeling becomes more interconnected with wider digital ecosystems, the focus is shifting from reactive problem-solving to proactive transformation. Businesses are looking not just to comply with regulations but to future-proof their labeling operations for the next wave of change.

How Veraciti™ Supports This Digital Labeling Future

These are exactly the challenges that Veraciti™, Kallik’s enterprise labeling and artwork management platform, was built to solve. Veraciti™ provides a single, centralized hub for managing labeling content across all markets, products, and packaging types.

It enables full traceability, ensuring every change is controlled, approved, and published accurately. With automated workflows, content reuse, and structured data management, Veraciti™ gives organizations the agility they need to respond to supply chain changes, regulatory updates, or global variations without introducing risk.

Its cloud-based architecture offers the highest levels of security and scalability, allowing global teams to collaborate in real time while protecting sensitive information. And as the industry moves toward digital standards such as ePI, Veraciti™ is ready and supporting structured content formats and integrations that will help companies transition confidently into the digital labeling era.

Looking Ahead

The conversations at both conferences reinforced what we already know: the pace of change in pharmaceutical and medical device labeling is accelerating. New regulations, digital standards, and supply chain challenges are rewriting the rules - but they’re also opening the door to smarter, more efficient ways of working. At Kallik, we’re proud to be ahead of the game with this, offering some of the world’s largest organizations the solution to all their labeling and artwork needs, all in one single, cloud-based platform.

If you’d like to learn more about how Veraciti™ can help your organization adapt to these industry shifts, get in touch with our team by calling +44 (0) 1827 318100 or emailing enquiries@kallik.com.

Moving Beyond Compliance: How Digitalized Labeling Strengthens Supply Chains and Patient Trust

From Compliance to Maturity

It has been several years since the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) came into effect. By now, most medical device manufacturers are familiar with Unique Device Identification (UDI) requirements and the EUDAMED database.

Yet, many organizations continue to face the same challenges:

• Fragmented supply chains with siloed labeling processes
• Difficulty maintaining a single source of truth across global markets
• Slow, costly updates when regulations or safety information change
• The ongoing shift to e-labeling and digital-first communication

In 2025, the conversation is no longer about what UDI is — it’s about how to embed digitalized labeling into core business processes and unlock real efficiency and trust.

The Case for Digitalized Labeling

Even though compliance is mandatory, labeling doesn’t need to be a cost center. By digitalizing labeling and artwork management, medical device companies can achieve:

Consistency: one authoritative master source for all content, across packaging, IFUs, and e-labels

Speed: instant updates to meet regulatory changes or safety updates

Transparency: end-to-end visibility and auditability across the supply chain

Efficiency: reduced duplication, faster approvals, lower costs
 

Interoperability & Global Readiness

While the basics of UDI are now standard practice, achieving global interoperability remains a challenge. Manufacturers must:

• Adapt labeling for different regional requirements while preserving accuracy
• Manage translations at scale without introducing errors
• Ensure full traceability back to the master content source

Companies relying on local systems or manual PDF-based processes struggle here — leaving them exposed to compliance risks and inefficiencies.

E-Labeling: The Next Competitive Frontier

Regulators now support electronic Instructions for Use (eIFUs), and adoption is accelerating. Patients and healthcare providers increasingly expect digital-first access to safety and usage information.

Organizations embracing e-labeling gain:

• Faster, more cost-effective content updates
• Reduced reliance on print production and distribution
• A more sustainable and modern approach to information delivery
• Greater trust from patients and healthcare providers who can access accurate, up-to-date content instantly

Overcoming Legacy Barriers

Many organizations still rely on outdated, fragmented labeling processes:

• Content locked in PDFs, print files, or emails
• Disconnected local printing systems
• Unclear ownership of data governance

These barriers prevent agility and make compliance more costly. The solution is to manage labeling at the atomic level — symbols, text, and data elements stored centrally and reused seamlessly across markets and formats.

How Kallik Helps in 2025

Kallik’s enterprise labeling platform, Veraciti™, helps medical device companies move from compliance-driven processes to true digital maturity:

• A single, digital master source for all labeling content
• End-to-end traceability and interoperability across global supply chains
• Built-in support for e-labeling and patient access
• Scalable, cloud-based compliance for any format, in any territory

By embedding labeling into digital strategy, organizations can transform a regulatory requirement into a driver of efficiency, trust, and competitive advantage.

The Verdict?

In 2025, the question is no longer “What is UDI?” but “How can we use it to build stronger, smarter, and more trusted supply chains?” Digitalized labeling is the answer. And with Kallik, manufacturers can move confidently beyond compliance into a future of transparency, efficiency, and patient safety. Want to learn more about Veraciti? Book a one-to-one demo or speak to our team and discover how Kallik can help you take control of your labeling and artwork at scale.

Email: enquiries@kallik.com
Call: +44 (0) 1827 318100

The medical device industry is one of the most heavily regulated in the world, and for good reason, as labels directly impact the safety of both the patient and healthcare provider. Yet, with a constantly shifting global regulatory landscape, manufacturers face mounting challenges in ensuring compliance. From EU MDR and FDA UDI to IVDR and GS1 standards, keeping pace with requirements is critical. This blog explores the key frameworks, the risks of non-compliance, and why medical device labeling software is essential for managing complexity across markets.

Understanding Global Medical Device Labeling Requirements

Medical device labeling requirements vary significantly across regions, but share the same goal: ensuring accuracy, traceability, and patient safety. Below are the most important regulations manufacturers need to navigate.

What is EU MDR (Medical Device Regulation)?

The EU Medical Device Regulation (MDR) came into full effect in 2021, significantly increasing the scope and requirements for labeling. Manufacturers must ensure labels include information such as unique device identifiers (UDI), symbols for safe use, and clear translation into all EU member state languages. MDR also places emphasis on electronic labeling in certain cases, making digital readiness essential.

What is FDA UDI (Unique Device Identification)?

The U.S. Food and Drug Administration’s Unique Device Identification (UDI) system requires most medical devices to carry a unique identifier that can be tracked in the FDA’s Global Unique Device Identification Database (GUDID). This improves traceability, supports recalls, and strengthens patient safety initiatives. Compliance deadlines vary by device class, but enforcement is increasingly strict.

What is IVDR (In Vitro Diagnostic Regulation)?

For companies producing in vitro diagnostic devices, the IVDR brings a new layer of requirements. Labels must include comprehensive information on device performance, safety, and use, as well as UDI information for traceability. Like MDR, it also mandates translations and standardized symbols to ensure global usability.

What Are GS1 Standards?

While not a regulation, GS1 standards play a critical role in global medical device labeling compliance. GS1 barcodes and identifiers are widely recognized across healthcare supply chains, ensuring interoperability between manufacturers, distributors, hospitals, and regulators. Many regulatory bodies, including the FDA and EU authorities, require UDIs to be GS1-compliant.

Other Regional Frameworks

• Health Canada has its own device labeling requirements, closely aligned with UDI initiatives.
• China’s NMPA has implemented UDI rules for specific classes of medical devices.
• Japan’s PMDA also mandates labeling standards that align with global UDI frameworks.

For multinational manufacturers, this means labeling compliance is not a one-time exercise but an ongoing, global challenge.

The Risks of Non-Compliance in Medical Device Labeling

Failing to meet medical device labeling compliance standards carries severe consequences:

• Non-compliant labels can lead to fines, forced product withdrawals, and reputational damage.
• A label that doesn’t meet regional requirements may prevent or delay market entry.
• Mislabeling or lack of traceability can directly endanger patients, which is the core reason behind strict regulations.
• Fragmented labeling processes create bottlenecks, increasing the risk of human error and slowing product launches.

How Medical Device Labeling Software Simplifies Global Compliance

To manage this complexity, manufacturers are turning to medical device labeling software as a centralized solution.

Key benefits include:

• Centralized control: A single source of truth for all label data ensures consistency across global markets.
• Automated compliance updates: Built-in rules and templates aligned with regulations like EU MDR, FDA UDI, and IVDR reduce manual effort.
• Global scalability: The ability to manage multi-language translations and region-specific requirements from one platform.
• Integration with supply chains: GS1-compliant barcodes and identifiers ensure interoperability with regulators and healthcare partners.
• Audit readiness: Complete version control and traceability simplify audits and inspections.

In an era where regulatory complexity is only increasing, investing in robust medical device labeling software is no longer optional, but integral to the success of your business.

Future-Proofing Medical Device Labeling Compliance

Global medical device labeling requirements are evolving rapidly, and the risks of falling behind are too high. By understanding frameworks like EU MDR, FDA UDI, IVDR, and GS1 standards, manufacturers can better anticipate compliance challenges. But true resilience comes from adopting medical device labeling software that centralizes, automates, and streamlines compliance efforts.

For manufacturers, this is not just about ticking boxes; it’s about safeguarding patient safety, protecting brand reputation, and ensuring continued access to global markets.

See what Kallik can do for your business with a future-proof, end-to-end, fully digital labeling process. Speak to one of our experts today by calling +44 (0) 1827 318100 or emailing enquiries@kallik.com. 

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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. 

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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.  

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.