UDI will stay with medical device manufacturers forever
As you may all know, barcodes on medical devices are not something new. In 2008 Japan’s MHLW has issued the “Guideline for Barcode Labeling of Medical Devices” and has been applying them for even longer. In 2013 US FDA issued a rule mandating phase by phase implementation of UDI. Subsequently, European Commission has adopted UDI as a part of the European Medical Device Regulation (2017/745) in 2017. Since that time, a lot of useful UDI-related guidance documents were issued by EU Commission for industry (find them here).
UDI/Devices User Guide was published just recently in order to guide manufactures step-by-step through the respective registration processes for registering Regulation devices, Legacy devices, Systems and Procedure Packs.
Other jurisdictions, such as Taiwan, Saudi Arabia, China, South Korea and many others are working on UDI implementation now or have already published draft regulation. Establishing a global process structure that will allow the ease of addition of new UDI jurisdictions and allows to consolidate device data in appropriate manner seems now is one of the key struggle to the manufacturers. However, looking into details across the various global jurisdictions, we can find some similarities that can help to reduce burden on manufacturers during UDI implementation and develop a global process serving multiple jurisdictions.
For instance, using a globally accredited provider (GS1, HIBCC or ICBBA) to establish the UDI-DI will provide for alignment in the UDI used throughout the globe. The FDA has accredited three organizations as UDI issuing agencies: GS1, HIBCC (Health Industry Business Communications Council) and ICCBBA (International Council for Commonality in Blood Banking Automation). Both the Health Industry Bar Code (HIBC) and the GS1 code are equally suitable for the UDI compliant marking of medical devices. The ICCBBA UDI code, as approved by the FDA, is best adapted to identify products of human origin (like plasma or transplants). These 3 agencies are designated to issue UDI almost everywhere in the world. The key difference would be in China, as this can be one of three entities: GS1, an international barcode and electronic data interchange standards organization, and two domestic organizations: the Zhongguancun Industry & Information Research Institute (ZIIOT), and AliHealth. The overview of the accredited agencies across the globe is shown in the Table 1.
Table 1. Designated issuing agencies
Key challenges while implementing the global UDI system?
Data management over the product lifecycle
Based on our experience the efficient data management is one of the key challenges in the UDI system implementation. It is not just about the definition/collection of UDI attributes in product development, later changes to medical devices may also lead to the changes in the UDI data, that can affect all the units where such data is stored. Manufacturers are required to use proper tools and techniques for the keeping up-to-date device data management and regulatory intelligence to avoid data missing or non-compliance.
Different timelines for UDI implementation across jurisdictions
The next challenge arises since each country has a different timeline for enforcement of the UDI system. For example, in 2021 Taiwan and Saudi Arabia almost at the same time launched the updated regulations require UDI to be in place for all Class III/Class D devices by June and August 2021, respectively. The timelines for enforcement of the UDI system in various countries are shown in the Table 2. However, some of these implementation dates can still be changed to help industry with implementation or due to Covid-19 response efforts. For instance, FDA postponed enforcement of UDI labeling and GUDID data submission requirements for Class I and unclassified devices Class I to September 2022 and Saudi Arabia SFDA shifted registration timeline for Class B, C and D devices from August 2021 to September 1, 2022.Table 2. The timelines for enforcement of the UDI system
Regardless of the different timelines, it is highly recommended to start implementing AIDC (Automatic identification and data capture) on all the device labels now, even if this is not mandatory in the specific jurisdiction. Since it will have become UDI when registering a device in the country-specific database.
Moreover, all the international regulatory authorities that are working on the UDI system implementation in countries other than the US and European Union, have discrepancies among different national approaches.
For example, EUDAMED does not require product attributes, such as sterilization methods and packaging type, while GUDID requires labelers to enter those attributes. Another example, Saudi Arabia required to duplicate brand name and device description in Arabic language in order to make it clear for use by lay persons or home use.
In China, 20 digits’ medical insurance code is one of the key elements that links UDI data with national medical insurance system. Apart from that, after submission, Device Identifier (DI) and some key elements cannot be edited and will always require a new request for approval before change.
Some of the differences in attributes among 5 jurisdiction are shown on the Table 3.
Table 3. Key differences in UDI attributes
Each jurisdiction define the special requirements to be applied in case of any changes made to the device itself or any of its elements. In general, the manufacturer will need to implement changes to the UDI-DI in case if such changes are necessary to ensure the correct identification and traceability of the device. For example, in the USA, EU, Saudi Arabia, the changes requiring the consequent amendments to the UDI include, the changes to:
- Quantity/quantity of devices provided in a package
- Brand/Trade Name
- Issuing Agency
- Primary UDI-DI Number
- Clinically Relevant Size
- Labeled as Single Use
- Labeled as containing natural rubber latex
- MRI safety information
- Device Packaged as Sterile
- The device requires sterilization before being used.
However, there are some specific situations where a change of a particular attribute shall be considered on case-by-case basis. In addition, the Issuing Agencies have their own rules when to change a GTIN used within open retail supply chains. For example GS1 requires to change the product GTIN when changing pack size or weight (a cutoff point of 20% to trigger a new GTIN).
Where to start with global UDI implementation?
UDI implementation is not just an update of the procedure for device labeling. Almost all the subsystems within a Quality Management System will require continuous adjustments to the different jurisdictions:
- Design control (UDI implementation shall be included in early stage of the Design Input process to allow manufacturer to consider the inclusion of the mandatory data in the global regulatory databases);
- Production and logistics (Including the operational steps of creating and generating labels with UDI and collecting the relevant data for future inclusion to global regulatory databases. The manufacturer should decide for each individual type/model when, where, and how the UDI carrier should be applied following various timelines per risk class, as required by different regulation);
- Change management (Including UDI as an important element of the Change Management process will help the manufacturer to ensure that any necessary UDI updates are considered during the change process and updated in the various databases in timely manner);
- Post-market surveillance and Vigilance (PMS documentation is required to implement UDI numbers within the records. This is also required for customer complaint management and for any reporting of serious incidences, adverse events, and any recall/field safety corrective action activity, the UDI number must be linked and included in the report. This can speed event review, analysis, and reporting).
- Supplier management (Manufacturers should investigate existing purchase activities and their controls to identify materials and equipment which may have an impact on the compliance of the UDI-system. This may include label material, printer, and scanner).
In order to plan for global UDI implementation, we strongly recommend to establish a Global UDI Implementation Concept or Procedure within your QMS to describe the approach to comply to the global UDI regulations. The procedure may contain more detailed country-specific work instructions that will defined different requirements for reporting information to their specific regulatory authority databases (Table 4) as well as rules for data collation and updates.
Table 4. UDI databases across the 5 jurisdictions
As of now, it's completely clear that more and more countries and regions will adopt UDI requirements in the nearest future. Having a well-designed process for global UDI implementation can save your time and struggle in meeting different UDI requirements in various jurisdictions. If you need assistance and subject-matter expertise contact us.