Labeling and compliance

Medical device approval processes can be time-consuming, regulations can change across borders, non-compliance could mean costly delays, and competition demands shorter times to market. These challenges require efficiency, and though labels may be physically small, their overall impact on supply chains will play a large role in the medical device industry for years to come.

Dated labeling procedures, such as manually hard coding label templates, verifying items by eyesight, or locally managing disparate printers and label data sources across facilities, won’t provide the agility needed to succeed. Adopting a modernized digital labeling strategy will be key for medical device manufacturers seeking to gain a competitive edge, maintain compliance, and improve supply chain processes.

Globally meeting compliance

Medical device manufacturers that operate internationally must align labeling with different standards, such as the EU Medical Device Regulation (EU MDR) as well as the U.S. Food and Drug Administration’s (FDA) guidelines.

Seemingly minute variations among regulations can be important. A manufacturer shipping in the U.S. that complies with FDA Unique Device Identification (UDI) guidelines, may be nine-tenths of the way to also meeting EU MDR standards. However, nuanced variations with differing label requirements can halt supply chains if an organization is not prepared to address them.

The MDR requirement to include an MD symbol inside a box, for instance, can present a major roadblock when altering labels manually. This often results in errors causing noncompliance or having to use information technology (IT) resources to code label changes in programs such as SAP, requiring more labor and slowing operations.

Modernizing, increasing efficiency

For organizations shipping overseas or domestically, improving label management brings many benefits. Migrating from hard-coding label templates to dynamic ones reduces IT workloads. Digitizing the entire quality control and assurance procedures improves manufacturing workflows for label approvals and changes, without needing manual operations such as printed proofs. Operations can be streamlined further by automating label approval and change procedures on a mass scale across many facilities, removing the need to individually design and approve hundreds or thousands of different labels for every stock keeping unit (SKU).

To incorporate automation, a label management system can create approved label templates for every SKU and then those templates can be locked down with the device identifier (DI) data needed for UDI sections of U.S. and EU requirements. Labels can then be prepared for production, where production identifier (PI) data – retrieved from enterprise resource planning (ERP), product lifecycle management (PLM), and manufacturing execution (MES) systems – can be added and merged.

Using a label management system that seamlessly integrates with ERP, PLM, and MES systems is key to efficiency because these systems provide highly accurate information, such as the DI and PI data used to satisfy regulations. Adding to efficiency is the rising adoption of validation-ready cloud labeling solutions.

Cloud migration

When implementing a label management system, carefully examine hidden costs that can be eliminated. Determine the role IT will play when quality and regulatory teams get involved. Juggling these concerns can be simplified by using a cloud-based system.

Moving to a cloud-based medical device labeling solution allows organizations to swiftly integrate labeling with their other systems to ensure regularly updated and readily compliant label templates.

Many cloud solutions guarantee that up-to-date documentation is readily available for the installation qualification (IQ) portion of validation, easing the validation burden and allowing teams to focus on operational qualification (OQ) and performance qualification (PQ). This allows manufacturers to efficiently respond to fast-changing regulations, even if teams are operating in separate locations.

Workflows and managing compliance can be further simplified with a cloud-based solution that has an extended print history, role-based access to the system and label templates, configurable approval processes, and better version control.

Labeling: now to the future

A 2020 study from Loftware revealed 91% of professionals across industries believe that maintaining one standardized labeling solution across their enterprise provides time and cost benefits, while more than 50% reported that the pandemic increased their company’s likelihood to adopt cloud-based solutions.

For the medical device industry, centralized and cloud-based solutions are proving useful. And for those faced with adapting labeling to changing regulations or new normal working conditions, it’s an opportunity to go digital and to the cloud.

No matter an organization’s location, efficiently meeting compliance in medical device labeling technologies is a necessity, which is why cloud-based or digital label management technologies that centralize and streamline operations are becoming more valuable to medical device manufacturers. For those still feeling beset by the challenges of maintaining labeling compliance, upgrading labeling will allow them to ease current operations, and then be equipped to compete in years to come.

NiceLabel
https://www.nicelabel.com

About the author: Susan Gosnell is a product marketing manager at Loftware, which recently combined with NiceLabel, and can be reached at labelingsolutions@loftware.com or 603.766.3630.