EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, director of sales with Loftware, an enterprise labeling and artwork management provider, to discuss common pain points in label development and maintenance as well as best practices to help companies to stay compliant with the ever-changing and diverse range of medical device regulatory requirements around the globe.
MedTech Intelligence (MTI): When should companies start developing their labeling for new devices?
Johnson: The labeling aspect should be part of the planning from day one, because you do need to consider the placement of the label on either the actual device or on the packaging that the device will be stored or shipped within. And sometimes that can be very small or limited real estate. So, you might need to be creative in terms of how to capture and display the amount of data that is required from a regulatory standpoint.
MTI: Who should be brought into that conversation?
Johnson: Usually the regulatory team. Quite often in medical device manufacturing, the branding and marketing team also has insight into what type of information needs to be on those different labels. There’s going to be common information, such as the product part number or description of the product, quite often a graphic related to what the product looks like and then symbols and barcode information. All of that can be fairly standard across different product lines and, usually, someone from either regulatory affairs or branding and marketing would have a good insight into what you need to have for formatting.
MTI: When it comes to the labels that are going physically on to the device, what are the best materials to use to make sure that the label is going to weather well, age well and stay where it’s supposed to be?
Johnson: If it’s a single-use product that is going to be disposed of, that label or the substrate that holds the label to the product may not need to be extremely durable or resistant to different temperature ranges or sterilization. However, a device that is reusable or in a surgical suite and is constantly being cleaned in between procedures needs an adhesive that is extremely resistant to different types of chemical compounds and sterilization processes. There are also devices that need to be kept in a cold environment, so that is a different type of adhesive or label if you’re talking about freezing temperatures.
This goes back to considering your labeling from day one. All those aspects of the product and how the product is going to be used need to be considered from the first day of development, and the label needs to be tested in these different use scenarios.
MTI: How did the new EU MDR regulations affect device labeling?
Johnson: There were some very big changes. For example, the change to the manufacturer address. Before, if the company was based in the U.S. but had a manufacturing facility in Europe, as a brand owner they could use the address of the U.S. facility. One of the major changes with EU MDR was that the address needs to reflect where that device was physically manufactured. There are also different ISO symbols required, so there were a number of different symbols and CE marks that needed to be updated.
It is a longer process than many people expected, because many manufacturers manage their label content or their labels as a one-to-one match with the product. So if you have 10,000 products, you need to modify 10,000 labels. So it has been a big undertaking.
MTI: Is one-to-one labeling a best practice, or is there a better way to handle the labeling?
Johnson: There are absolutely better ways to do this, and that’s what many organizations took a look at following the EU MDR. Their legacy solutions process was this one-to-one ratio, so they had to go in and make these modifications on each label. Many companies took the new regulations as an opportunity to evaluate more modern solutions and software to be able to manage what we refer to as dynamic labeling.
With dynamic labeling, you have a template that can support multiple different products and that template is based on the size of the label itself. For example, if you are manufacturing part A on Monday and part B on Tuesday, and they go into a similar-sized package, you can use a single template to support full integration to your system of record, whether that’s your ERP or MES solution, for the required product information and symbols. Also, it allows for sharing of the symbols and different cautionary statements in order to make the management of your overall labeling and template library much easier.
MTI: When it comes to tracking regulatory changes and responding to them, what should companies have in place to make sure that once those changes happen, they can address any required labeling changes?
Johnson: That is something that has proven to be fairly challenging, because regulations vary by region and country to country. Oftentimes organizations will manage that with their regulatory affairs or government affairs teams internally using something as simple as a robust spreadsheet or a SharePoint site where they can share that information between different departments as required, and keep it up to date.
The term medical device covers everything from a Band-Aid and surgical gloves all the way to implantable devices, so understanding your product portfolio is imperative, and tracking those regulatory requirements based on the classifications of the products you manufacturer can be cumbersome.
With dynamic labeling, you can implement business logic or business rules. If you’re manufacturing a product for Europe, for example, you know those labels need to have specific statements translated into multiple languages as well as specific ISO symbols. Once a regulation is defined, putting those parameters—or logic—into your labeling software helps to ensure that the regulations are being met and that the data elements are appearing on the labels as they are printed in production.
So it’s two-fold process. One is tracking the regulations as they are happening, and the other is keeping the system up-to-date to support them.
MTI: What happens in the scenario where a company gets FDA clearance for a new indication, in terms of labeling changes to the device?
Johnson: The labeling update process usually takes a little while—it can take months for some devices—so there is leeway allowed as that new product is being released for additional or new use cases. The company would have the ability, if the product is in stock and labeled with the original label, to apply a secondary label if it’s being shipped out for that new indication while they’re making the label updates to the core template for future production runs.
MTI: What are some of the most common pain points for companies in terms of regulatory problems related to labeling?
Johnson: The regulations are constantly changing. That seems to be the biggest one. Another challenge is that there is always pressure to reduce costs and to be more efficient and, of course, the labels need to be perfect, meaning they need to be exactly what was approved by the different regulatory agencies.
This is where dynamic labeling also can be helpful, because you are able to make those changes and have them affect multiple templates at the same time. This supports that reduction of effort and reduction of cost because you are making mass changes and then verifying those mass changes rather than going into every label individually, making the change and then doing the verification.