FDA Class I just the beginning
There is a wave of regulations hitting medical device manufacturers (MDMs) with international operations. In addition to the upcoming deadlines for US FDA Class I and the EU MDR date of application, the in vitro diagnostic regulation (IVDR) date of application goes into effect in May 2022. After that, there are a number of other application dates in the Netherlands, England, South Korea, China, Saudi Arabia, Australia, Canada and India on the horizon. All of these countries have device identification requirements that will be taking effect over the next few years. Thus, the message for webinar attendees was clear: Now is the time to take a standardized approach to UDI compliance, and select a process that can be scaled to cover additional regulations in the pipeline.
- According to the webinar poll, 51% of attendees marketed their medical devices to the US, and 46% to the EU. 18% of attendees had not started their preparation for EU MDR submission.
EU UDI Requirements
After briefly reviewing the FDA Class I UDI requirements, Gary shifted gears to talk about the EU MDR requirements. Now that the date of application has shifted to May 2021, MDMs have extra time to familiarize themselves with regulation requirements and make sure their labels are compliant. The delay also gives MDMs the opportunity to consider the best approach to compliance. Gary mentioned that authorities have also delayed the launch of the EUDAMED database to May 2022, which is the same date of application for the IVDR. MDMs should expect an 18-month period for legacy devices to register in EUDAMED; however, some of the EUDAMED modules will be released early, so MDMs can make voluntary submissions early on, a year before the actual deadline.
Fact box: EU UDI requirements
- Full UDI on Device Label and packaging, presented in human-readable plain text and Automatic ID and Data Capture (AIDC) technology, e.g. 1D/2D barcode, RFID
- Permanent UDI marking on reusable devices
- Submit device ID and attributes to the EUDAMED database
- Reporting requirements: include UDI in annual reports, post-marketing surveillance and the Patient Implant Card
How compliance is an opportunity
Gary then turned the webinar over to NiceLabel’s Lee Patty, who urged attendees to view compliance exercises as an opportunity to improve their internal processes. “The Medical Device industry in general is undergoing this digital transformation that’s being driven by regulation,” Lee stated. “Remember to look beyond the regulations and uncover the hidden costs and problems that you might have in your workflow.” Here it’s important that MDMs leave no process stone unturned. “When you go through this transformation, go through everything. This is about more than just buying a tool or a system; it’s about process improvement. So don’t just use your existing processes; find ways to improve them and then place the technology on top of that optimized process,” he said.
Picking up on the compliance label flows Gary presented, Lee talked about the process of maintaining compliant labels. “Now that you’ve designed the label, it’s been submitted and approved, how do you make it work inside your operations? That label has to fit into your production process at some point, and it’s important that your labeling technology makes it easy for you to deploy and scale your labeling operations, while maintaining compliance and accuracy.” Lee then posed a thought-provoking question: “Can you reevaluate the labeling process you have today and focus on preventing errors, as opposed to catching them?”
Easing compliance with labeling in the Cloud
Lee went on to speak about how Cloud-based labeling solutions can help MDMs to quickly create compliant labels. “Cloud technology makes it easier for you to meet regulatory requirements no matter where you are or where your suppliers are. Remote access to labeling allows you to deploy labeling to your various sites, business partners, contract manufacturers, relabelers and repackagers.”
According to Lee, this approach enables MDMs to ensure consistent labels throughout the supply chain. “If you give a drawing of a label to 10 different contract manufacturers, chances are you’re going to get 10 different labels back. With labeling in the Cloud, you actually use the same label asset that you’ve designed for your own internal use, distribute it out to third parties, and get the same label back.”
Ideal approach for MDMS of all sizes
For smaller MDMs, such as Class 1 manufacturers, Cloud-based labeling helps them comply with regulatory requirements without making a significant IT infrastructure investment. With labeling in the Cloud, these manufacturers get access to the best technology, security and availability, without the infrastructure and maintenance.
For larger MDMs with in-house IT departments, developing compliant labels can be complicated and time-consuming, especially if they’re using legacy approaches to labeling. Here it’s important for MDMs to allow technology to ease the compliance burden. “Designing a UDI-compliant label shouldn’t be an arduous process. It shouldn’t be something that IT has to write source code to actually generate. These labels are living things; they change frequently and there needs to be a high degree of flexibility and speed around how these labels are designed and approved so that they can enter production in a controlled manner,” Lee said. This is again where the Cloud comes into play. Digital, cloud-based labeling can ease the burden on IT departments and expedite the label creation process. It gives MDMs an easy-to-use tool to visually layout the label; a digital, visual workflow for quality control; the ability to automate mass label changes and approvals; and label printing that’s integrated with the business systems that house UDI data. And unifying the entire label creation and management process in one labeling system makes the validation process easier, as MDMs only have to validate one digital system and quality process.
To find out more about labeling in the Cloud, click here.
To access the full webinar recording, click here.