Final versions of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (IVDR) go into effect May 2020 and 2022, respectively. These regulations, alongside the already launched U.S. Food and Drug Administration (FDA) unique device identification (UDI) ruling, have impacted how medtech companies develop and market products for use and distribution. Even with seven notified bodies and counting, manufacturers remain concerned with the looming compliance deadline. A recent statement from the European Commissioner for Health emphasized the May 26, 2020, MDR deadline holds, despite any postponement of the EUDAMED database.
EU MDR requirements
Most medical devices and instruments will require a UDI. The journey toward compliance for the U.S. and EU is similar, with medtech manufacturers looking to adopt enterprise-wide programs of change management and ensure total compliance to identify medical devices through distribution and use.
Many companies are finding the transition to UDI compliance challenging as they adapt to a more holistic label management system. UDI labeling means a manufacturer includes a device identifier (DI), production identifier (PI), and associated barcodes. In the EU there is also a Basic UDI to help manage device models as the primary identifier, serving as the main record key in the UDI database. The Basic UDI-DI is entered into the EUDAMED database and is how any relevant certificates, declarations of conformity, and other key documentation will be referenced. However, it’s not a supply chain identifier and is not required on the label; it simply links all UDI-DIs related to a single device.
While similar, U.S. and EU UDI guidelines contain distinct differences.
- UDI management responsibility falls to the legal manufacturer of the device; U.S. rules place responsibility with the labeler
- EU date format is not defined; U.S. date format is standardized
- EU direct UDI marking must be automatic identification and data capture (AIDC) and human readable interpretation (HRI)
- In the EU, if there are space restrictions, the barcode format will be favored unless the device is intended to be used outside of health institutions
Compliance and quality
The regulatory paradigm has shifted from straightforward compliance to a greater focus on total quality. It’s not only how to increase manufacturing and product confidence, but how to reach the market faster while improving information systems for regulatory decisions and resource allocation. Medical device makers are consumed by the UDI ruling in the U.S. and abroad in an effort to drive a shift from organizational excellence and innovation to focus on what’s most important to patients.
The ecosystem is changing, and the approach has created a competitive marketplace for medical device quality with higher expectations for manufacturers to produce high-quality devices more consistently and reliably. The manufacturer must demonstrate a patient-safety focus and responsiveness to issues and speed in identification, containment, and action, meaning more accurate reporting and analysis of adverse events so problem devices can be quickly identified and recalled. Standard identifiers help manufacturers, distributors, and providers manage recalls effectively, so many are sourcing new tools and solutions to remain competitive ahead of the data tidal wave UDI has created.
UDI mandates are tangentially improving controls and sustainment across supply chain, production, and final product with metrics to demonstrate visibility to production data and relevant analytics through all fabrication levels. The most helpful tools in the framework are collaboratively and concurrently adding information for better decision making, yielding a more efficient and higher quality medical device – tools demonstrating strong, proactive prevention and continuous improvement.
A research study conducted by Axendia in 2017 found that the top three worries keeping medical device manufacturers up at night are a slow and cumbersome change and configuration management process, unintended consequences, and compliance concerns. Improved systems can aid change management and ensure regulatory compliance based and predictive management systems of manufacturing equipment with digital reporting of key manufacturing steps such as the content placement and verification of UDI data.
An eye for UDI
How does a manufacturer watch over all this data and labeling to ensure they are compliant by May? Use another set of eyes by implementing smart camera and image processing systems to augment quality management. Vision systems can detect, verify, and provide traceability to UDI laser marking. These systems can ensure the UDI label is correctly positioned on the device or instrument and inform users if the component is missing or has already been marked, minimizing scrap.
Data transfer is simplified with a variety of possible points to pull from a database connection or directly from a production traveler via barcode scanner. The code can be automatically populated with the corresponding UDI in a compliant barcode format. Following laser marking, the vision system assesses its quality and stores the result in the manufacturer’s production database. A complete solution for UDI marking has been accomplished – from data processing to the permanent laser marking of the medical device. It all supports digitalizing medical device manufacturing setup and enhancing operational efficiency and product quality.
Peak performance strategies
In the final drive toward the EU MDR launch, medtechs are rapidly and continually adopting software and data information solutions to ensure compliance and real-time access of already established quality management systems. Bringing in predictive, condition-based monitoring solutions that optimize machine production capacity and product lifecycle mean increased availability and productivity. Global standards will continue to align to enhance risk management and detail life cycle approach to medical device regulation. As International Organization for Standardization (ISO) and MDR requirements for companies selling on a global scale continually refine – staying ahead on automation and digital tools can make the competitive difference for medical device manufacturing.