September 6, 2017
Unique Device Identification (UDI) System – Path toward Global Harmonization?
On Sept. 24, 2013, the Food & Drug Administration (FDA) mandated 78 FR 58786 (the UDI Rule), herewith establishing a unique device identification labeling system in line with the requirements of 21CFR830.20. Medical device labelers must submit product information to the FDA’s publicly accessible Global Unique Device Identification Database (GUDID). In addition, the UDI Rule requires every medical device distributed and used in the United States to bear a UDI – unless exempt.
A UDI consists of two components: the device identifier (DI) and the production identifier (PI). The DI specifies the labeler and the version or model of a device. The PI specifies one or more applicable sections of the following: lot number, batch number, serial number, expiration date and/or manufacturing date. Combining these two components, the label of medical devices will display a unique alphanumeric code that allows identification of medical devices throughout distribution and use.
When fully implemented, the UDI system can offer various benefits to industry, the FDA, consumers, health care providers and health care systems, including improving patient safety, modernizing device post-market surveillance and vigilance, fighting counterfeiting and fraud, and creating transparency and traceability throughout the distribution chain.
In parallel to these FDA implementations, the Medical Device Regulation 2017/745/EU (MDR) came into effect on May 25, 2017, mandating a harmonized UDI system in Europe. This European UDI system uses the FDA UDI system as a starting point, as it is based on U.S. FDA UDI requirements, though there are some differences in device package labeling and barcode requirements. In addition, the structure of the European UDI Database (EUDID) is expected to be different from GUDID. Device labelers will have a transition period until May 2020 to meet the MDR requirements. Implementing the new European UDI system imposes a significant challenge to manufacturers, as currently approved medical devices are not exempt from the new UDI requirements. As the FDA did, the UDI system will be implemented in steps, starting with the highest risk classes. Although final introduction of UDI for Class I reusable medical devices is required on May 26, 2027, European UDI timelines may be shortened because of an initiative in The Netherlands.
The UDI system is being implemented in the U.S. in various phases over several years, starting with the highest-risk classes from September 2014 onward. A significant number of Class III and Class II medical devices are now required to comply with the UDI Rule. As a result, a great number of labels now display a UDI and the GUDID has become a large repository of product identification information. As of May 1, 2017, 1.4 million records have been submitted to the database. These implementation efforts are building toward full compliance with the UDI Rule. Class I and unclassified medical devices constitute the last group that must be compliant with the UDI Rule, on September 24, 2020.
On June 21, 2017, the Dutch Minister of Health signed an agreement with health care providers, manufacturers and distributors of medical devices to adopt the FDA’s UDI system outright. These efforts promote the introduction of the FDA UDI system in Europe, potentially accelerating the UDI introduction process in Europe. Since no other European member state has taken this step to date, this agreement sets the industry standard for manufacturers that want to distribute their medical devices in The Netherlands. All implantable medical devices will be required to have a UDI code on their labels by July 1, 2018. >
The FDA, the European Union and the Dutch Ministry of Health are all working toward one goal: a single, harmonized global device identification standard system. As the UDI system is being instituted in both the United States and in Europe, now is the time to become familiar with the UDI system requirements – make sure you are ready to keep up with the changing medical device identification environment!
Factory CRO is an expert medical device CRO, available to address any questions you may have and to assist you in ensuring your devices are in compliance with the current U.S. and EU regulations.