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The new European Union regulations for medical devices (EU MDRs) will have major implications for the labeling operations of every medical device manufacturer that trades in the EU. The regulations have far-reaching impact, and they are why labeling has recently become a mission-critical business system for medical device companies. Failure to produce accurate, MDR-compliant labeling may result in organizations that are no longer able to distribute their products in Europe, causing products to be unnecessarily stockpiled or even resulting in costly and embarrassing product recalls.
The needs for new symbology and additional warning and precautions statements as well as the requirement to carry details of a licensed EU representative are likely to result in labeling congestion. In some cases, this may require a major redesign of label layouts and possibly accelerate the move from linear to 2D bar codes to capture more data in a machine-readable format. Some aspects of the new symbology indicating that the product is a medical device are still to be finalized. Given that potentially thousands of labels will be impacted, now would be a good time to take the opportunity to rationalize the global labeling estate.
Making wholesale changes to labeling and artwork assets in timescales dictated by the management board or in this case, regulatory bodies, can be a huge undertaking. It’s likely that many products will have been in existence over a long period of time and a variety of different processes and systems will have been used for label creation and printing, resulting in very little standardization.
The opportunity for rationalization is significant, but it takes executive-level sponsorship to embark on such an initiative and engage all stakeholders. Such involvement is needed because labeling changes can have organization-wide impact, and there are always other priorities demanding scarce resources. However, EU MDR is not just about labelling.
These regulations are broad-reaching and impact many aspects of product design, manufacture, and distribution, along with preparing underlying data for submission to EUDAMED. Taken together, there is opportunity to overhaul labeling processes to be better positioned to respond to regulations across other territories. While enforced change is never welcome, organizations must ask themselves whether adopting best practices now for EU MDR compliance is a better approach than doing it all again in the future.
Embracing EU MDR for Best Practices
By using the new regulations as an opportunity to cleanse their labeling data, device manufacturers can choose to make this the last time valuable resources are diverted from day-to-day activities in order to hunt down the thousands of impacted labels. There is no simple shortcut to this part of the process, but with the right approach, it becomes a downstream value-creating activity rather than a short-term business overhead.
The first step is to locate the source files for all impacted labels. In some cases, this is not going to be possible, and ultimately, new master artworks will need to be created from existing labels. The next step is look at the opportunity for rationalization. This is much more than performing a simple side-by-side comparison to seek out similarities and duplicates. It requires careful analysis based on a deep understanding of labeling practices and experience in building the case for reducing the number of unique assets, while seeking agreement among the various stakeholders.
An understanding of the regulatory environment as well as the need to maintain the correct relationships between symbology, phrases, and template layouts is also required. Often, there can be reluctance to change, but implemented effectively, this rationalization can deliver outstanding downstream productivity gains and far greater levels of accuracy.
Enabling a “Joined-Up" Approach
The next step is to store each phrase, symbol, and graphic as unique digital assets, capturing their relationship to the label templates and making them visible to the teams responsible for managing labeling. This will provide a robust platform on which to implement the required changes.
This is most easily performed using a solution that overcomes the common restraints imposed by on-premise equipment. In other words, a cloud-based solution could connect historically disconnected people and processes. Modifying existing label layouts to capture the new symbols, statements, and other label content required for the EU MDR then becomes a much simpler task. It also makes each label visible to all stakeholders and simplifies collaboration, change, and compliance.
Adopting this solution is a key enabler in helping reduce the impact of future regulatory and organizational-driven labeling changes. This is where the downstream benefits can really be felt. Bringing labeling under control to meet the broader reaching regulatory requirements of the EU MDR can ease future regulatory changes. All localized, uncontrolled variances have either been eliminated or rationalized down to the lowest common denominator, and future changes start from a clean sheet rather than an unknown commodity.
For future changes, each impacted label can now be quickly identified, updated, and re-printed along with a complete audit trail of changes, making it easy to demonstrate due diligence to regulatory bodies when requested. This buys organizations time to manage the variables associated with the downstream label printing processes and provides adequate time for testing and validation.
Now is the Time to Act
May 2020 is nearing, leaving a little more than one year to prepare your labelling approach. A single, joined-up approach can provide you with the ability to manage and transform your labeling estate and prepare for change. It’s important to remember, however, that no software solution is going to deliver a benefit without first carrying out the rationalization and consolidation activities discussed above. Organizations adopting this approach will find themselves better equipped to respond to future legislative changes, new market opportunities, and the inevitable day-to-day labeling challenges in bringing new products to market.
Kallik is a global provider of labelling and artwork management solutions for highly regulated industries.Supported by a dedicated team of experts in labelling design and process transformation, Kallik’s AMS solutions offer global organisations a platform to manage and transform their global messaging in print and online via a single joined-up, cloud-based solution. Discover more about Kallik here.