Implementation status of medical device unique identification (UDI) in various countries around the world

Medical Device Unique Identification (Unique Device Identification, abbreviated UDI) is the electronic ID card for medical device products. In the context of the information age, UDI is an advanced means of international medical device regulation and a "common language" for global traceability of medical devices.

In recent years, the national drug regulatory authorities have actively promotedthe application of UDI in China's medical device field, and on December 20, 2018, issued the medical device industry standard "Basic Requirements for Unique Identification of Medical Devices." This standard will be implemented from January 1, 2020. Currently, some enterprises are already exploring UDI. In March of this year, Shandong Weigao Group Medical Polymer Products Co., Ltd. announced the implementation of the UDI system, having completed the UDI coding of all products, established a UDI database, and achieved data sharing and interaction. This also indicates that China's medical devices are about to enter the UDI era.

Medical Device Unique Identification (UDI is a hot topic in the field of international medical device regulation, and it is the development direction of innovation and efficiency improvement in regulatory means. UDI is important basic work. In the era of informationization, Internet+, and big data, current hot topics in the regulatory field, such as the construction of traceability systems, real-world evidence, and the re-evaluation of medical devices, are closely related to UDI. Establishing a UDI system is an effective way to achieve intelligent regulation.

International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force for Medical Devices (GHTF), established a UDI special working group in 2008 and adopted the "Guidance on Unique Device Identification System" (hereinafter referred to as the "Guidance") in September 2011. In 2012, IMDRF replaced GHTF and, based on the "Guidance," supplemented and improved the "Proposed Rules for Unique Device Identification System," expecting regulatory authorities worldwide to build their own UDI systems according to these proposed rules. Currently, UDI continues to be implemented under the new global framework of IMDRF and has been actively promoted in developed countries and regions such as the United States, the European Union, and Japan.

United States: First to implementUDI

In 1999, the Institute of Medicine of the United States published the research report "To Err is Human" (Institute of Medicine 1999). The report pointed out that the incorrect use of drugs and medical devices is one of the main causes of medical accidents. Barcodes can effectively avoid and reduce the misuse of medical devices, thereby greatly reducing social costs. In 2004, the U.S. Food and Drug Administration (FDA) issued regulations requiring the use of barcodes on drug labels. During the drafting stage of the regulations, the FDA publicly solicited opinions on whether this regulation should be extended to medical devices. However, during the review process, the FDA decided not to apply this rule to medical devices because medical devices lacked standards and unique identification systems similar to the National Drug Code system.

Although the regulation decided not to apply drug barcodes to medical devices,the FDA did not give up its exploration of UDI, because the FDA recognized that unique identification not only helps reduce medical errors, facilitates recalls, and identifies device compatibility or allergic reactions (such as MRI and latex), but also helps improve inventory control, improve reimbursement methods, and reduce counterfeit products. To this end, the FDA actively carried out relevant research and promoted the implementation of UDI. The FDA Amendment Act of 2007 established the legislative basis for implementing the UDI system; the FDA Safety and Innovation Act of 2012 clarified the time frame for implementing the UDI system; in September 2013, the FDA issued the "Medical Device Unique Identification System Regulations," clearly requiring the phased implementation of UDI over seven years according to product risk levels until all products are fully covered. During this period, the FDA also issued multiple guidelines to guide companies in meeting regulatory requirements and adjusted the implementation dates for some types of products. Currently, all Class III and Class II medical devices in the United States have implemented UDI, and Class I and unclassified medical devices will be implemented from September 2020.

During the implementation ofUDI, the FDA established a dedicated UDI team and a UDI Helpdesk to answer questions companies encounter during implementation. The FDA opened the database upload function when the regulations were released in September 2013 and opened it to the public in May 2015. As of February this year, the database has more than 2 million master data records.

European Union: Establishing a large database platform

In April 2013, the European Union issued a recommendation on a common framework for medical device unique identification systems, intending to implement the UDI system within the European Union. In May 2017, the European Union issued regulations on medical devices and in-vitro diagnostic reagents, stipulating that only medical device products with UDI can legally Enter the EU market and circulate freely. According to the regulations, the EU will gradually implement UDI from 2021, according to the type and risk level of medical device products, over six years, until full coverage.

It is worth noting that the U.S.UDI system database is a single module, while the "Eudamed" that the EU will establish is a large platform covering multiple areas of the entire life cycle of medical devices, requiring multiple parties to participate in data maintenance and multiple user access management (supervision, enterprises, the public, and third-party certification bodies), and the UDI database is only one part of it. Compared with the United States, which only requires companies to input and update data, the EU database system has more participants, better functions, and better expected results. However, correspondingly, the EU will also pay higher costs for system construction and maintenance, and the difficulty of database construction is greater. Currently, the database is still under construction and is expected to be put into use on March 26, 2020.

Japan: Proposing requirements in the form of a notice

Since2002, the Japanese Ministry of Health, Labour and Welfare has conducted an annual survey on the progress of medical device informationization. In June 2007, the Japanese Ministry of Health, Labour and Welfare promoted regulatory reform, promoted a three-year plan, and issued the "Notice on the Implementation of Barcode Display for Medical Devices, etc." in March 2008. The main purpose is to improve logistics and medical insurance settlement efficiency. Within three years of the issuance of the notice, Japan gradually promoted it according to the risk level of medical devices, and the Medical Information Systems Development Center established a database to register information related to medical device barcodes. According to a domestic survey in Japan in 2018, the coding rate of medical device outer packaging has reached 96%, the coding rate of single medical device packaging is 88%, the database field upload rate is 77%, and the database fields are approximately 1 million. It is worth noting that Japan proposed UDI-related requirements in the form of a notice, mainly driven by the back-end such as distribution, sales, and medical insurance reimbursement settlement.

Progress in other countries and regions

2In 2012, IMDRF was established, and the UDI working group was established in the same year. In 2013, IMDRF released the "UDI System Guidance," which is a framework document on the UDI system. In September 2017, the IMDRF Management Committee approved the "IMDRF UDI Application Guidance," which is a refinement of the 2013 system guidance at the implementation level. The final document was adopted at the IMDRF Moscow meeting in March of this year.

InOf the 10 countries and regions in the IMDRF, the United States and the European Union have already issued UDI-related regulations, while Brazil, China, and South Korea have issued draft regulations for public comment. Japan, Canada, and Australia have issued UDI-related notices and guidance documents. Among the countries that have signed cooperation documents with China for the "Belt and Road" initiative, Saudi Arabia has issued draft regulations for public comment, and Turkey has established a registration and traceability system database. In South America, countries such as Colombia and Argentina are also actively promoting the implementation of UDI projects, with Colombia issuing a draft UDI regulation and Argentina issuing a medical device traceability regulation.