On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices in Canada. This is Health Canada’s first consultation on the UDI system for medical devices.
What is a Unique Device Identifier (UDI)?
A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters assigned to a specific medical device on the market and is created through globally accepted standards. A UDI code on a medical device allows tracing and tracking of the medical device through the healthcare system, from its entrance into the market through to its use in a patient.
What is the purpose of the consultation?
The purpose of the public consultation is to explore the feasibility of introducing a UDI system in Canada, including options for the development of a UDI database by leveraging internal existing infrastructure. Health Canada proposes building on the work and experience of the International Medical Device Regulators Forum (IMDRF), as well as the United States Food and Drug Administration’s implementation to inform the principles and design of a UDI System for Canada. The focus of the public consultation is to seek feedback on:
- Introducing a Unique Device Identification (UDI) system for medical devices in Canada
- Who should be responsible for establishing and maintaining the Canadian UDI database
- The potential scope of regulatory and legislative amendments required to establish a UDI System in Canada
What is IMDRF and what do they do?
IMDRF stands for International Medical Device Regulators Forum. The International Medical Device Regulators Forum is a voluntary group of medical device regulators from around the world who work to support convergence in the area of medical device regulations. The International Medical Device Regulators Forum published the original guidance on a global Unique Device Identification System for Medical Devices in December of 2013. The guidance provides a high-level framework for how a globally harmonized device identification system should work.
According to the guidance document on UDI developed by the International Medical Device Regulators Forum, a UDI system must have three interrelated components:
- UDIs must be based on global standards
- UDIs must be applied to the label of a medical device and its associated packaging
- Information about the medical device must be submitted to a UDI database for the purpose of data sharing amongst regulators and other healthcare stakeholders
What will the feedback from this consultation be used for?
The feedback gathered through this public consultation will be used to inform the assessment of options for the potential implementation of UDI in Canada and the next steps. Should Health Canada choose to pursue a UDI system, there will be further consultation with stakeholders. Health Canada will share the results of this consultation in a timely manner on the Health Canada website.
What are the benefits of implementing a UDI system?
Implementing a UDI system in Canada will bring several benefits to industry, government, consumers, healthcare providers, and the healthcare system, such as:
- More accurate reporting
- Reduced medical errors
- Collection of “real-world data”
- Patients can track their own devices
- Effective management of medical device recalls
- Addressing counterfeiting and diversion of medical devices
Who should participate in the consultation?
Health Canada is seeking feedback from industry professionals, provinces and territories, health care organizations, and the general public.
Interested parties can participate in the public consultation. The consultation will close on September 30, 2021.
Top Frequently Asked Questions about the Unique Device Identifier (UDI)
Q1: What is a Unique Device Identifier (UDI)? A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters uniquely identifying a medical device on the market. It contains specific information about the device, such as the manufacturer, model, production batch, and expiration date.
Q2: Why is UDI important for medical devices? UDI is crucial for enhancing patient safety, streamlining recalls, improving post-market surveillance, and ensuring the traceability of medical devices throughout their lifecycle. It also helps healthcare professionals and patients access essential information about the device.
Q3: Who assigns UDIs to medical devices? UDIs are typically appointed by the device manufacturers. The manufacturer must comply with regulatory requirements to designate and label each medical device with a unique identifier.
Q4: What Information Does UDI Contain? UDI includes information such as the device’s identifier, production lot or batch number, expiration date, manufacturing date, and, if applicable, the device’s serial number. The specific information contained in UDI can vary based on regulatory requirements.
Q5: How Does UDI Benefit Patients and Healthcare Providers? UDI benefits patients and healthcare providers by providing accurate and easily accessible information about medical devices. In recalls or adverse events, UDI helps healthcare providers quickly identify and locate affected devices, ensuring patient safety.
Q6: Is UDI mandatory for all types of medical devices? Regulations regarding UDI requirements vary by country. However, many countries, including the United States and members of the European Union, have implemented UDI systems, making it mandatory for most medical devices, including Class I devices.
Q7: How does UDI improve medical device traceability? UDI improves traceability by providing a standardized and globally recognized identifier for each medical device. This allows regulators, manufacturers, and healthcare providers to trace the device from production to patient use, enhancing accountability and safety.
Q8: Does UDI compliance differ across countries? Yes, UDI compliance requirements can vary across countries and regions. Manufacturers must adhere to the specific regulations outlined by the respective regulatory bodies in the countries where their devices are marketed.
Q9: How can manufacturers obtain UDI numbers? Manufacturers can get UDI numbers by registering with the appropriate issuing agency in their country. In the United States, for example, the FDA manages the Unique Device Identification (UDI) System, and manufacturers must request a unique identifier from the FDA-accredited issuing agency.
Q10: What is the role of UDI in the medical device recall process? UDI plays a crucial role in medical device recall by enabling swift and accurate identification of affected devices. In the event of a recall, UDI helps locate devices on the market, notify healthcare providers, and remove the affected devices promptly to prevent patient harm.
Q11: How long should UDI information be retained? Manufacturers are typically required to have UDI information for a specific period, as outlined by regulatory authorities. It is vital to comply with these retention requirements to ensure traceability and compliance in case of audits or recalls.
Q12: Are In-Vitro Diagnostic Devices (IVDs) Subject to UDI requirements? Yes, in many regulatory frameworks, In-Vitro Diagnostic Devices (IVDs) are subject to UDI requirements. UDI implementation for IVDs ensures traceability, enhances patient safety and facilitates efficient post-market surveillance and recalls for these devices.