Recently medical device manufacturers and industry members met together in Bethesda, Maryland to discuss best practices and current challenges in device labeling and regulatory affairs. For those who could not attend the conference, the Reed Tech team has prepared this summary of three main themes related to Unique Device Identification.
1. Global Challenges
Manufacturers are struggling in a globalized medical device market to create a single label that can be used internationally. The differences in regional regulations and the speed with which they change create a number of obstacles. Monitoring these regional changes can be a costly, time-intensive task for regulatory and labeling departments. Additionally, these varying regulations can affect internal processes and supporting systems. One manufacturer noted that a newly-implemented labeling system was “outdated as soon as it was launched” due to changing regulations.
In addition, managing labeling content in multiple languages across a global market proves challenging for device manufacturers. Translation of device labels, Information for Use (IFU) documents, and related materials is a costly process that can often take months of collaboration. Industry leaders discussed the merits of adapting XML-based IFU authoring and reuse of approved, translated content.
Manufacturers and industry members also discussed the growing momentum of Unique Device Identification (UDI) mandates across the globe. As device manufacturers work to meet FDA compliance deadlines for UDI, many companies are seeking to capitalize on the investment of these compliance efforts for coming UDI mandates outside the U.S. While full harmonization is unlikely, many of the data attributes required for submission to the FDA may be applied internationally.
2. “Good” Data
Conference presenters focused on the importance of accurate data throughout the labeling and regulatory process. One topic of discussion was error management throughout the GUDID submission process, which echoed the FDA’s calls for “baked-in” data quality.
To reduce potential errors, conference attendees suggested establishing a single data source for labeling and regulatory data. Additional suggestions to increase data accuracy included maintaining proper change control and establishing a robust internal review process prior to submission and label printing.
3. Managing Multiple Classes of Medical Devices
Manufacturers of multiple classes of devices discussed the challenges of managing data for a wide variety of products.
One presenter posited that time and money spent on regulatory needs for higher classes of medical devices was much greater per product than time and money spent on lower classes of medical devices. However for many manufacturers, Class II and I devices make up a much larger portion of the product portfolio. Additionally, manufacturers of Class II and I products may be eligible for exemptions or extensions and should spend time reviewing guidance documents and their impact on a manufacturer’s portfolio. For these companies, time should be allotted for fully understanding regulatory requirements and manufacturers should be aware that labeling and UDI compliance may require buy-in from many dispersed internal departments.