Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Canada

Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Canada

June 2021

Introduction

Canadians rely on medical devices to maintain and improve their health and well-being. Canada has one of the strongest regulatory systems in the world for medical devices, with some of the most stringent requirements. Through various initiatives, such as the Medical Devices Action Plan (MDAP) and Agile Licensing for Medical Devices , Health Canada is taking steps to further promote the safety, effectiveness and quality of the medical devices used by Canadians. As such, Health Canada has been studying the feasibility of introducing a Unique Device Identifier (UDI) system for medical devices in Canada.

A UDI is a series of numeric or alphanumeric characters that is assigned to a specific medical device on the market, and is created through globally accepted standards. A UDI code on a medical device enables the tracing and tracking of a medical device through the healthcare system, from its entrance into the market through to its use in a patient. A fully implemented UDI system offers a range of benefits such as; providing patients with the ability to track their own devices, and reducing medical errors by enabling healthcare professionals to rapidly and precisely identify a device among others.

Internationally, the United States Food and Drug Administration (US FDA) and the European Commission (EC) have made strides in the area of a UDI system. The Australian Therapeutic Goods Administration (TGA), and China’s National Medical Products Administration (NMPA), are also considering the implementation of a UDI system. For example, TGA launched two online consultations to seek input from stakeholders on the feasibility of introducing a UDI system in Australia. In August of 2019, the TGA published the results of the first consultation, which was followed by a second UDI consultation that concluded in December 2020, the results of this consultation are not available yet.

Background

According to the guidance document on UDI developed by the International Medical Device Regulators Forum (IMDRF) in 2013, a UDI system must have three interrelated components:

1. UDIs must be based on global standards;
2. UDIs must be applied to the label of a medical device and its associated packaging; and
3. Information about the medical device must be submitted to a UDI database for the purpose of data sharing amongst regulators and other healthcare stakeholders.

1) UDIs must be based on global standards
In order to provide a consistent approach to creating UDIs and to ensure that each UDI is unique, the IMDRF specified in their guidance that globally accepted coding standards, such as those developed by the International Organization for Standardization (ISO) or the International Electro technical Commission (IEC), are required for the development of the UDI numbers. Agencies that aid in the implementation of these ISO/IEC standards can be accredited by regulatory authorities to assist manufacturers in establishing UDIs on their devices. Examples of these agencies include Global Standards One (GS1), the Health Industry Business Communications Council (HIBCC) or International Council for Commonality in Blood Banking Automation (ICCBBA).

2) UDIs must be applied to the label of a medical device and its associated packaging In order to avoid confusion, once a UDI is fixed on a device, it should be changed only in cases of reprocessing, remanufacturing or relabeling. When a new model or version of a device is manufactured, it should be assigned a new UDI number. The IMDRF guidance states that the UDI should be an additional requirement in all jurisdictions and should not replace any other identifiers, markings or labelling required by a given jurisdictions.

3) Information about the medical device must be submitted to a UDI database
Under the IMDRF guidance, it was envisioned that regulatory authorities would create UDI databases that would store a list of core data elements about medical devices marketed in that jurisdiction and that this database would be accessible to the public. The database should use a web-based interface and accommodate a specific document format for data submissions (Health Level 7 Structured Product Labelling). By using a common platform for data submission and a web-based interface, it would be possible for regulatory authorities to transmit information on medical devices to one another.

What are the Components of UDI?

A UDI is a series of numeric or alphanumeric characters created through globally accepted standards and assigned to a specific medical device on the market. The code is provided in both human- and machine- readable formats and is comprised of two components: the device identifier (DI) and the production identifier (PI). The DI is specific to a model of medical device and is used to access a repository of information stored in a UDI database. The PI captures units of device production, such as serial number, lot/batch number, manufacturing and/or expiration date. The DI can be used on its own to serve as the identifier of the product. The PI is a dynamic number that will change once a new lot or batch of the device is made.

The following diagram illustrates the different parts of a UDI, as an example:

Figure 1 - Text description

This figure above describes the two components of a Unique Device Identifier (UDI):

• The first component on the left is the Device Identifier, which is used to access the information stored in a UDI database.
• The second component on the right is the Production Identifier, which captures the expiry date, lot/batch number and serial number of the medical device.

Who will be affected by UDI?

It is anticipated that all stakeholders throughout the medical device lifecycle will be affected by the implementation of UDI. This would include patients, health care professionals, hospital administrators, researchers, manufacturers, provincial and territorial governments, as well as Health Canada, the federal regulator. The far-reaching implications of a UDI program would place responsibilities on each of the above parties, but could also yield significant benefits for all components of the healthcare system.

What are the benefits of implementing the UDI System?

A fully implemented UDI system offers a range of benefits to industry, government, consumers, healthcare providers and the healthcare system. For example, a fully implemented UDI system can be expected to:

• Allow for more accurate reporting , review and analysis of adverse events so that safety issues with devices can be identified and corrected more quickly;
• Reduce medical errors by enabling healthcare professionals to rapidly and precisely identify a device;
• Support the collection of ‘real world data’ by providing a standard way to document device use in electronic health records, clinical information systems, claim data sources and registries;
• Provide patients with the ability to track their own devices ;
• Allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls due to the use of a standardized identifier; and
• Help to address the counterfeiting and diversion of medical devices.

For these reasons, we anticipate that the proposed establishment of a UDI system in Canada will benefit consumers, healthcare professionals, scientists, researchers, the medical device industry and regulators.

International initiatives

The International Medical Device Regulators Forum

The IMDRF is a voluntary group of medical device regulators from around the world,^{Footnote 1} as well as industry, members who work to support convergence in the area of medical device regulations. After years of discussion and consultation, the IMDRF published the original guidance on a global Unique Device Identification System for Medical Devices in December of 2013. This UDI guidance provides a high-level framework for how a globally harmonized device identification system should work, with the intention and capability of having regulators share data.

In 2017, industry representatives at the IMDRF tabled a proposal to the IMDRF Management Committee

on the development of a UDI Application Guide to guide regulators wishing to implement a UDI system. The Application Guide was finalized in March of 2019 and is intended to be used as a supplement to the 2013 guidance. It provides a high-level framework for regulators to facilitate consistent development of UDI systems in different jurisdictions.

The United States Food and Drug Administration

The US FDA issued final regulations for a UDI system in September of 2013 with a multi-year phased approach for implementation. These comprehensive regulations require that all medical devices have a UDI on their label and package, except where the regulations provide for an exception or alternative placement. The UDI must be provided in both a plain-text version (readable by humans) and in a form, that uses automatic identification and data capture (AIDC) technology (readable by a machine). The UDI must be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. Manufacturers may also choose to display only the DI on the device label.

Manufacturers and importers are required to submit their device’s product information to the US FDA's Global Unique Device Identification Database (GUDID) . The GUDID will only contain the DI portion of the UDI and information about device use. The website is publicly accessible and manufacturers are able to input into the database directly. More information on the US FDA’s UDI requirements is available on the US FDA’s website.

In the guidance issued in July 2020, the US FDA stated that it would delay enforcement of UDI requirements for Class I and unclassified devices until September 2022 due to lack of resources, given that significant resources are being used to address COVID-19, as well as due to the complexity of UDI implementation and integration into the healthcare system.

The European Commission

In the Spring of 2017, the European Commission (EC) published new regulations on the approval and use of medical devices within the European Union. These new regulations established a comprehensive European database on medical devices and a device traceability system based on UDI.

In April 2020, the EC agreed to delay the implementation of the new Medical Device Regulations, given the challenges of addressing COVID-19.The revised date of application is now May 2021, instead of May 2020. These new regulations will require manufacturers to have a UDI number for their medical devices.

The EC has also stated that they will begin to release modules of their UDI database as early as May 2021 so that users can begin to familiarize themselves with it.

The devices requiring UDIs on their labels, as well as the placement of the UDI, is governed by guidance that has been developed by the EC. The UDI database being developed by the European Commission to store the UDI data is called the EUDAMED. It is anticipated to contain information about the lifecycle of all medical devices available on the European market. The Commission will be responsible for maintaining the EUDAMED database.

Australian Therapeutic Goods Administration

In January of 2019, the Therapeutic Goods Administration (TGA) of Australia launched a high-level consultation on the possibility of introducing a UDI system in Australia. The consultation introduced the concept of UDI and asked whether Australian manufacturers, healthcare providers and patients would support the use of UDI within Australia.

In August of 2019, the TGA published the results of the consultation, including the submissions received from various stakeholder groups. The responses supported the need for the UDI system and suggested that it be based on IMDRF guidance, aligned with other international agencies, and linked to the Australian Register of Therapeutic Goods.

In September 2020, the TGA launched a second UDI consultation to further explore options for the introduction of a UDI system in Australia that concluded in December 2020. The consultation asked questions related to the benefits of UDI for the healthcare system in Australia, and whether a first phase of UDI should include a limited number of high-risk devices. Results of the consultation were not available at the time this paper was written.

The Proposed Canadian UDI System

Canadian context

In Canada, there are over 1 million medical devices on the market. While Canadian-based device identifiers are used for medical devices, there is limited ability to differentiate between models of device, sizes, and other product characteristics. As such, Health Canada feels that Canadians would benefit from the creation of a UDI system.

As a member of the IMDRF, Health Canada has been working since 2013 with its international counterparts to develop policy for a harmonized global UDI system. Despite Health Canada’s involvement in the development of the UDI guidance as part of the IMDRF, there has been hesitation to put in place a UDI system in Canada due to several factors:

• The cost of UDI implementation can be significant, to both government and businesses;
• The benefits of UDI are only fully accrued if all players in the system adopt UDI, including healthcare professionals, medical offices and hospitals; and
• The establishment of a UDI database, either public or private, would require significant investment to build and maintain.

Despite the above mentioned challenges, this may be an optimal time for Health Canada to consider pursuing a UDI system as changes are being made to how medical devices are regulated in Canada, including initiatives under Health Canada’s Forward Regulatory Plan 2021-2023: Regulations amending the Medical Devices Regulations (Agile Regulations), where Health Canada’s focus is on implementing an agile, modern licensing scheme to effectively regulate medical devices throughout their life.

Following the publication of the 2013 IMDRF guidance, Health Canada sent a notice to stakeholders regarding UDI. Health Canada committed to informing stakeholders of its next steps on UDI by the summer of 2016. However, due to competing priorities, work on this initiative was temporarily delayed.

Since 2017, Health Canada has continued to study the possibility of implementing a UDI system in Canada and the potential impacts that it would have on stakeholders, and has periodically discussed the issue of UDI implementation with industry stakeholders, mainly through existing bilateral meeting programs. Feedback from medical device stakeholders indicates that they continue to be supportive of the initiative.

Health Canada’s UDI Proposals

Health Canada is proposing a UDI framework based on the three components identified in the IMDRF guidance document, namely:

1) UDIs in Canada would be based on global standards

• In order to have UDIs based on global standards, Health Canada would create regulations to accredit appropriate agencies to work with manufacturers in developing UDI numbers.^{Footnote 2}
• Manufacturers would be responsible for ensuring that their devices have a UDI affixed on the label after approval, in compliance with any proposed regulations, and they would be responsible for working with accredited agencies
• Manufacturers selling products both in Canada and internationally would be expected to maintain the same UDI number on all products, in compliance with any proposed Canadian regulations.
• Health Canada would encourage the use of the UDI throughout the Canadian healthcare system, including in provincial/territorial government offices, in hospitals and in medical clinics.

2) UDIs would be applied to the label of medical devices sold in Canada and their associated packaging

• Health Canada would require that UDIs be placed on all devices with the exception of custom-made devices, Class I devices and certain other devices.
  • Health Canada is proposing not to require UDIs for Class I devices due to their low level of risk, and the fact that many Class I devices sold at retail establishments are already tracked through existing SKU (Stock Keeping Units) and UPC (Universal Product Codes) codes.
  • The choice to exclude Class I devices is consistent with that of the US FDA to exempt low-risk devices.
• Health Canada would require that manufacturers of implantable medical devices put the UDI on patient information leaflets and on implant registration cards.
• Health Canada would require that re-manufacturers and private labellers retain a record of the original UDI of the device, as well as label the device with a new UDI.
• Manufacturers would be responsible for complying with all requirements relating to the UDI system, including ensuring that all UDI information is consistent and valid on the device, its labelling and its packaging.
• Requirements would be phased-in, according to risk class. Additional guidance would be developed to interpret the new regulations.
• Health Canada would propose regulations to modify the current definitions of ‘identifier,’ ‘control number,’ and ‘catalogue number.’ Health Canada would also propose new entries for definitions for ‘Unique Device Identifier, and possibly “Device Identifier” and “Production Identifier.”

3) Information about medical devices would have to be submitted to a UDI database for the purpose of information sharing

• Health Canada is currently looking into the feasibility of creating a Canadian UDI database where manufacturers could input the necessary information for their devices, and users could look up information about devices in both English and French.
  • If Health Canada created this database, manufacturers would be responsible for inputting the UDI DI, and some core data elements, into the database, in both English and French. These core elements have not yet been determined.^{Footnote 3}
• As an alternative option, Health Canada is considering modifying the existing Medical Devices Active Licence Listing to contain and display the UDI numbers of medical devices that are licensed in Canada.
• Health Canada will not make the UDI PI or any commercial information available through a Canadian UDI database, or through a modified MDALL.

Contact us

Bureau of Policy and International Programs
Medical Devices Directorate
Health Products and Food Branch
Health Canada
Holland Cross-, Tower A
1600 Scott St.
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9
Email: mddpolicy-politiquesdim.sc@hc-sc.gc.ca

Feedback from the consultation

We are seeking your comments and ideas, and responses to the stakeholder questions. The input gathered through this process will be used to develop a UDI system for medical devices in Canada.