Medical Device Labeling

Managing regulatory labeling challenges in the medical device sector

Ken Moir Medical Devices

A unique device identification (UDI) system for medical devices is essential in identifying them wherever they are in the healthcare supply chain. In fact, the United States Food and Drug Administration (FDA), the European Commission and other regulators have made patient safety a strategic priority by developing legislation for UDI.

And in addition, manufacturers also need to comply with the EU Regulations on medical devices (MDR) and in-vitro diagnostic devices (IVDR) as well as 21 CFR Part 11.

While these standards are essential to patient safety and enable an efficient process for all healthcare stakeholders worldwide, it can also be a regulatory challenge to those manufacturers who need to maintain compliance for each label on every product, and often this needs to be done in multiple languages.

Understanding the challenges

Therefore, it’s not surprising that almost one-third of senior medical supply chain executives list regulatory compliance as the biggest challenge facing their industry. And as much of the regulation concerns identifying products correctly, labeling has become center stage.

The pressure to reduce costs, especially in the supply chain, is another challenge facing device manufacturers, as is maintaining quality and reducing labeling errors. In a worst-case scenario, labeling errors could potentially lead to lawsuits, but even minor errors result in product recalls which can be extremely costly in terms of both time, labor and potentially lost business.

One company that was facing such challenges is LiNA Medical. Its manual labeling process required the production identifier portion of the UDI and other information to be manually entered, leading to frequent misspelling and other errors. In addition, it was possible for production operators to change labels by accident and print history needed to be manually tracked for compliance.

Clearly, there was a need in terms of regulatory compliance, quality improvements and cost implications, to move to a more seamless and transparent process.

Solving the challenges

A modern label management system (LMS) provides the traceability required by FDA UDI and EU MDR/IVDR regulations. It guarantees that all labels include the required UDI device identifier and production identifier information, as well as clearly logging actions and print history in order to respond to regulatory audits. Also, only one version of the ‘true’ label is held, minimizing the likelihood of errors.

When business rules are established in the LMS, business users can handle label changes without causing permanent changes to the approved template, leading to a more efficient process and one with less errors as well. Consequently, the whole process is less costly.

Quality control can also be assured with a modern LMS as information can only be accessed by authorized personnel and it provides a complete and auditable label change and print history against anyone with access.

LiNA Medical realized these benefits through the implementation of a modern LMS system. All its work orders are now integrated within its labeling processes. There is a centralized document management system for UDI compliant labeling and all label designs and approval workflows are streamlined and happen within the system. The whole process is also completely transparent as all label variants are completely traceable.

This has led to a more agile environment, where label changes happen in a fraction of the time that they used to, and mislabeling incidences have dropped, resulting in time and cost savings for LiNA Medical.


Quality and compliance are essential in the medical devices industry, but this can come at a cost. However, implementing an LMS can minimize inaccuracies and improve quality control processes, therefore avoiding costly errors and maintaining compliance.

Companies relying on a legacy systems approach to labeling often need a lot of manual processes and they could struggle to compete with other more agile device manufacturers. With such clear benefits, it makes sense to implement a modern LMS now, before industry regulations tighten any further and processes become even more unwieldy.

Find out how your business can benefit from a modern label management system – visit

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