Traceability throughout the lifecycle is increasingly under pressure in the medical device industry. Crammed with the concerns in and around safety, regulatory compliance, and product recalls, the Unique Device Identification (UDI) system of the European Union is expected to do a great deal more with respect to its cruciality.
Born out of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), it seeks through the establishment of a common device tracking system to standardize the tracking of medical devices.
It is a simple process that improves transparency and accountability, UDI equally works to maximize the traceability of devices as far as their regulatory compliance is concerned in the EU market. This article discusses UDI’s significant relevance, implementation challenges, and manufacturer solutions for regulated compliance.
The Role, Challenges, and Strategies for UDI Implementation
Indeed, the UDI system forms one of the cornerstones towards improved traceability reality for medical devices in Europe and better patient safety and compliance with regulations. It addresses the critical need for effective tracking systems, particularly in a market characterized by far-reaching impact due to product recalls or caused by the occurrence of patient injuries due to faulty devices.
The system comprises two significant configuration parts: Device Identifier (DI) – where static information is retrieved as to the device model, and Production Identifier (PI) – which holds dynamic production detail like lot numbers, serial numbers, and expiry dates of the device. Together, the two elements establish extensive identification mechanism for medical devices. Basically, manufacturers are expected to comply with MDR requirements such as the marking of devices with UDI codes, registration of this information into EUDAMED, and aligning processes with the risk-based classification system.
Implementation challenges related to UDI entail harmonization of this system with existing workflows in the manufacture and supply chain, upgrading obsolete technologies, and besides such general harmonization, the consistent collaboration of suppliers, distributors, and regulatory authorities. Manufacturers may overcome these challenges by adopting an organized framework that is proposed as including building robust tracking systems, performing regular audits for compliance, and training employees for the proper execution of duties.
It is equally important to use advanced software tools to streamline UDI management, improve compatibility with labeling systems, and minimize disruption in production and distribution.
A few real examples of this include a leading manufacturer that has implemented UDI as a result of investing in technology and training employees proactively; and another, which overcame considerable integration hassles with targeted system upgrades. Best practices in UDI data management include continually updated records, accurate verification of information submitted to EUDAMED, and the use of barcode scanners or automated data management solutions to eliminate errors.
All these efforts together will permit manufacturers to meet regulatory requirements within a streamlined operation while ensuring safety for patients in seamless traceability throughout the product lifecycle.
Conclusion
It is indeed an important EU UDI system by which traceability and compliance of medical devices can be further improved. It underscores the need for standardization in the UDI, making it applicable for manufacturers to secure access to the market. By patient safety, UDI would have structured data management, solid training, and good integration into the supply chain process.
UDI can earn a company value-added service rather than just necessary compliance. It includes greater confidence from stakeholders, more efficient management processes, and so forth. UDI regulations will continue changing in a forward-looking manner. Therefore, manufacturers shall always be proactive to continuing monitoring regulatory updates to adapt their compliance strategies. The industry can then make great strides toward creating a safer yet more transparent medical device ecosystem in the EU market.
References: MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI
Author
Sabeel T, BE Biomedical engineering
Jr. Consultant-Medical Device