EU Medical Device Regulation (EU MDR) will make traceability and identification measures compulsory for all medical device labeling within the EU market. For many businesses, this will mean a complete overhaul of their labeling operations. With the new regulation ready to be implemented in May 2021, this article explains how medical device manufacturers can ensure they remain compliant with new regulations and are prepared for future regulatory changes.

Medical device manufacturers should have spent the last few years preparing for the EU’s major overhaul of official safety controls governing medical devices both used and sold across its jurisdiction. All new medical devices entering the European market must comply with the new EU MDR requirements. The implementation of these regulations has been delayed to 2021 and even though this may have been welcomed during a time of overwhelming business disruption caused by the pandemic, businesses should not view the deadline extension as an excuse to delay operational changes until the last minute. Manufacturers should see the delay as an opportunity to adequately prepare their operations to ensure increased compliance.

Keeping up with the Packaging
Medical device manufacturers have, until now, had the luxury of more relaxed controls over traceability, device manufacturing, product lifecycle monitoring, and reporting when compared to the adjacent biotech and pharmaceutical sectors. When added to the relative size of many of the involved firms, this has meant global labeling management and other similar processes haven’t previously been viewed as a board-level priority.

Most businesses view labeling with a typical disjointed approach, in which physical labels are created as templates using data from ERP systems, then printed manually on a factory floor while other customer-facing materials such as instructions for use (IFU) leaflets are produced by separate teams and external design agencies. This will no longer be tolerated under the new regulations, which will require more systematic process coordination and content uniformity.

The inbound regulation will, for some manufacturers of medical devices, mean a complete overhaul of labeling operations to ensure consistent labeling is achieved. There are four key challenges manufacturers will need to overcome—and a capable automated labeling solution will be crucial to a manufacturer’s success.

Regulatory Change Impacts Identification and Traceability Efforts
A scandal similar to the PIP breast implant scandal of 2009/2010 can still happen and MDR has been designed to avoid this. Incorrect product labeling means they lack the stipulated transparency as they progress through the supply chain from factories to pharmacies and doctors, who in turn, supply them to recipient patients.

With MDR, every product produced—whether a bandage, a pacemaker, or a set of crutches—will need to carry a unique device identifier (UDI) on its labeling to enable rapid lookup if an issue arises. Products with faults will be able to be tracked in batches and pinpointed within the market for targeted remedial action—but only if consistent, accurate, and reliable labeling practices are adhered to.

A more defined strategy regarding enterprise labeling and artwork will become crucial, as stringent new MDR measures demand information be logged in the EU database—EUDAMED—a prerequisite of marketing medical devices within European markets. Products need to be labelled correctly with specified safety symbols and information, as well as meeting the set requirements surrounding electronic IFUs.

Changes to labeling at any scale can impact reliability and quality. Small adjustments disrupt layout, often leave partial sections of barcodes missing and obscure critical wording. It is vital manufacturers cease relying on manual processes to ensure all labeling output consistently meets the new regulations.

A Global One-Stop Shop for Labeling ‘Truth’
Without clear control, visibility, and systematic coordination across all products in all channels and markets, manufacturers have no chance of keeping up to date with product identification and traceability, nor managing it with the efficiency and rigor needed.

As MDR compliance draws nearer, manufacturers will come to realize their in-house systems are not capable of implementing the new EU requirements across global operations. The big challenge for in-house teams responsible for implementing EU MDR changes is, although they may recognize said changes need to be made, putting the correct labels onto packaging and products for global distribution operations is difficult.

Digitizing the labeling process and developing a single labeling source of “truth,” maintained by any global authorized team, from which all materials and product information is distributed is the only way businesses can ensure reliability and consistency across all markets and channels.

Don’t Leave Changes to the Eleventh Hour
It’s easy to underestimate the scale of work involved in implementing MDR changes and many organizations will wait until it’s too late. Manufacturers should be aware that highly complex scenarios, developed from a mix of disjointed processes they may be operating at the moment with dispersed teams and duplication of content sources (e.g., where translations have existed separately for IFU and label creatio will take a significant amount of time to resolve.

Organizations that delay MDR preparations to the last minute will be forced by time constraints to conduct the minimum standard to achieve regulatory compliance. This means some businesses may end up spending more than those that prepared, being forced to adopt expensive solutions that fail to deliver compliance confidence, quality control, or the process efficiencies manufacturers need.

More Regulatory Changes Loom
It is important to remember too that MDR won’t be the last major global change to impact the industry, so companies should take the time to implement changes now and be better prepared to weather change implementation in the future. For instance, product serialization on device labeling seems likely to become a mandatory requirement in the coming years.

Currently, manufacturers marketing products in Europe are only required to provide UDI information to the EUDAMED database. However, as of May 2021, detailed product serialization information and product identifier codes will have to appear on all product labeling. The looming 2021 deadline will apply for the most-safety-sensitive—Class III—devices, followed in 2023 by Class II, and finally followed by Class I items in May of 2025. There will be plenty for manufacturers to get right in the near future; the UDI will have to appear in plain text on all packaging parts of a product, include a wealth of highly specific information beneath two differing categories (a product identifier and a device identifier), and be machine readable.

Act Now!
For the industry, EU MDR marks the first-time changes to both IFUs and labels have arrived simultaneously, highlighting how unprepared some organizations’ existing processes currently are. Companies should, if they have yet to do so, review how extensive their inefficiencies are and begin developing a common approach to their management of market-facing information based on shared data, common content, and connected working.

Implementation of a compliant and consistent labeling solution will ensure medical device manufacturers increase both transparency and accountability, reduce compliance risks, and optimize global label management processes in the run up to MDR’s implementation deadline. With the desire for transparency and consumer self-service not seeming likely to fade anytime soon, manufacturers seen as readily able to comply and willing to give consumers the reassurance they need will be rewarded with market confidence around their brand and products.

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Bob Tilling is the VP of global sales at Kallik, a provider of medical device labeling solutions.