UDI Compliance for Medical Devices: Part II

Adoption of UDI by Select Countries: Similarities and Differences

To review the basics of UDI and building a UDI program, start by reading Part I of this two-part series.

Today, the world is attempting to align to a single approach for unique device identification (UDI). This rule requires medical device manufacturers to label their products through a UDI with human-readable and machine-readable forms of the device type and production variables, the UDI-Device Identifier (UDI-DI) and UDI-Production Identifier (UDI-PI), respectively. 

Looking for more insights into global UDI alignment? Author Mark Agostino presented the recent webinar, “Unique Device Identification | Aligning to a Single Approach.”

Failure to attain alignment limits the ability of global manufacturers and regulators to effectively react to product quality issues and identify postmarket surveillance trends. 

It is an important topic for the medical device industry and worthy of in-depth coverage and discussion. The following is a deep dive into the similarities and differences of UDI adoption by select countries. Specifically, what are these countries doing to implement UDI and align with current regulatory thinking on the topic, including:

• Which countries follow the guidelines created by the International Medical Device Regulators Forum (IMDRF)?
• What are the various issues with implementation they are dealing with?
• How do the data attributes differ in various countries’ UDI databases?

At the AAMI/FDA/BSI Virtual International Conference on Medical Device Standards and Regulations, BSI Sector Lead-Medical Devices Lena Cordie-Bancroft answered these questions and more as part of her presentation on the implementation status of UDI for several countries.

Australia

One of the countries moving forward with UDI implementation is Australia,  Cordie-Bancroft noted.

As described in Figure 1, the Therapeutic Goods Amendment Act of Australia released in February 2021, implemented UDI in accordance with IMDRF guidelines. The Act was informed by work completed by the U.S. FDA and other regulatory authorities, along with the EU Medical Device Regulation (EU MDR). Cordie-Bancroft explained two public consultation sessions were held to solicit feedback on the governing regulation. 

In addition, she emphasized the AusUDID (Australian UDI database) data elements will be similar to the EUDAMED and FDA requirements. She explained that “for a manufacturer`s sustainable global UDI system, you are able to link the data from the European Union, United States, Australia’s TGA, and various other countries.”

By recognizing the GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBA) issuing agencies, Australia is implementing a UDI system that not only works for that country but also aligns with other countries. The mutual recognition agreement between Australia and the European Union has furthered the synergy between the two countries, as demonstrated by the data elements in their respective UDI databases.

Brazil

Next, Cordie-Bancroft stated the publication of the UDI regulation by the Brazilian Health Regulatory Agency (ANVISA) was expected to happen by the end of 2021 (Figure 2). At this time, there is no confirmation that the ANVISA UDI regulation 1051/2021 has been published.

The timeframe for compliance with this regulation is a function of the date of publication. The plan is to roll out UDI in Brazil over a six-year period from the point of publication, as shown in Figure 2.

One of the key points she describes in her presentation is that Brazil will follow the Global Medical Device Nomenclature (GMDN) code that aligns with the U.S. FDA but not the European Union, which uses a European Medical Device Nomenclature (EMDN) coding system.

Therefore, manufacturers need to be aware of this difference when comparing data in Brazil’s UDI database to UDI data from other countries. The challenge in the nomenclature for the coding of medical devices is that countries do not always use the same system. A country can choose to use:

• GMDN or EMDN
• A combination of GMDN and EMDN
• A unique national system
• No system at all

The alignment of the UDI approach needs to overcome this challenge. Particularly, manufacturers need to be cognizant of the fact that Brazil recognizes the GS1 and HIBCC issuing agencies, but not the ICCBBA issuing agency in developing their regulatory and production strategies.

Also,  Cordie-Bancroft pointed out custom-made devices and investigational devices will be exempt from UDI requirements under Brazilian regulation. Postmarket vigilance notifications will require UDI information in the reports.

In summary, Brazil is working to establish its own UDI database with aspects that align with other countries but, overall, its system is unique. Manufacturers need to keep these differences in mind when comparing UDI database information in Brazil.

China

“In addition to the standards, China has been doing a lot of work on UDI,” Cordie-Bancroft said. 

As shown in Figure 3, China implemented a UDI system in January 2021 for high-risk devices. This system covers devices manufactured after the date of implementation (devices manufactured before the date of implementation do not fall within the scope of China’s UDI requirement). Cordie-Bancroft highlights that this is a positive outcome for manufacturers since no rework of devices is required. 

In China, all parties, including the public, will have access to the medical device identifier database. Also of note, China has four issuing agencies for UDI.

 Cordie-Bancroft points out GS1 China may differ from other GS1 agencies yet remains “compatible.” Compatibility helps interpret UDI data between different countries that use the GS1 issuing agency, and China does recognize other issuing agencies based in China. Furthermore, unlike the United States and European Union, China does not accredit the issuing agencies.

China established the infrastructure for a UDI program. However, it needs to expand the program to include medium and low-risk medical devices. It is important that manufacturers are aware of the potential difference in attributes of the data existing in China’s database.

European Union

UDI is currently a big topic for the European Union. Cordie-Bancroft’s first point, as shown in Figure 4, is that all devices need to have a Basic UDI and a UDI-DI assigned as of May 2021. The higher levels of packaging need to be assigned a UDI in accordance with the timeline requirements noted in the table.

There are two modules within EU MDR 2017/745 that describe the regulatory requirements for UDI, effective October 2021:

1. Article 27 indicates the requirements for the UDI system
2. Article 28 indicates the requirements for the UDI database

In addition to the requirements stipulated in EU MDR, there are a number of Medical Device Coordination Group (MDCG) guidance documents on the topic of UDI. In particular, MDCG 2021-19 Guidance note integration of the UDI within an organization’s quality management system is very helpful for manufacturers intending to market devices in the European Union.

Cordie-Bancroft emphasized the necessity to “keep on top of the various MDCG guidance documents as they are very helpful and informative in walking through questions” related to UDI.

Japan

Japan continues to be at the forefront of traceability. As noted in Figure 5, Japan released the Pharmaceuticals and Medical Devices Act of 2019 based upon IMDRF requirements. Therefore, Japan’s UDI program possesses a number of similarities to the U.S. and EU programs. 

Also, GS1 is the issuing agency for Japan. Thus, the data being collected in their UDI database aligns with other countries using GS1. As noted in the Act, UDI must be present on the packaging for all medical products.

Contact us to see how medical device manufacturers can pull actionable insights around UDI-related FDA 483 observations.

Saudi Arabia

Cordie-Bancroft was pleased to introduce the discussion of UDI in Saudi Arabia, describing the Saudi Food and Drug Authority (SFDA) guidance as “very clean and easy to understand.” As noted in Figure 6, the guidance was updated in September 2020, while the SFDA database became effective in October 2020.

The MDS-G34 guidance adopted many of the basic definitions from the EU MDR and U.S. FDA concerning data attributes. Cordie-Bancroft specifically pointed out the guidance states “the barcode shall be verified according to the appropriate ISO/IEC standard,” which supports an expectation that a barcode verification should be conducted for the medical device UDI. Also, Saudi Arabia recognizes the same issuing agencies as the United States and European Union.

Another key point of the guidance is that all healthcare systems within the Kingdom of Saudi Arabia need to incorporate UDI. This is a very proactive stance, going even further than the systems employed in the United States and European Union. 

In summary, the UDI system for Saudi Arabia aligns with aspects of those in the European Union and the United States. The SFDA has even taken an additional step to harmonize UDI utilization throughout its healthcare system.

United States

In comparison to other countries, the U.S. UDI system is advanced (Figure 7). By September 2022, all devices in the United States should have:

• UDI in their labeling
• Data submitted to the FDA’s Global Unique Device Identification Database (GUDID)
• Direct parts with UDI marking, where applicable

In summary, the UDI system for the United States continues to lead and set the standards for those in other countries.

Conclusion

The breadth of variability in the adoption of UDI and assimilation within the countries assessed by  Cordie-Bancroft in her presentation is evident. Manufacturers supplying regulated medical devices to the United States, European Union, China, Saudi Arabia, and Japan use the GS1 standards to implement the UDI requirements, however, regulations and practices vary.

While the options for selecting an issuing agency that is recognized are consistent across several countries, the selection of an issuing agency recognized by various countries is important for the countries you intend to market.

The multiple options for adoption of UDI that exist impact the information held in a UDI database. Because of this, manufacturers need to not only be aware of the differences that exist from country to country but also need to have a UDI program and quality management system agile enough to accommodate these potential variations.

Additional Resources

UDI Compliance for Medical Devices: Part I

Postmarket Medical Device Surveillance at CDRH: Part I

Postmarket Medical Device Surveillance at CDRH: Part II

EU MDR and Economic Operators for Medical Devices