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