How is the world aligning when it comes to unique device identification (UDI)? Why is it important to understand where a medical device has been used, where it exists in the supply chain, and where it exists at any given point in time?
[Related: Looking for more information on UDI? Click here to access a recording of our January webinar featuring author Mark Agostino.]
The development of UDI has been a long time in the making, from the involvement of the Global Harmonization Task Force (GHTF) (now the International Medical Device Regulators Forum (IMDRF)) to ongoing adoption by many countries. Regulators and manufacturers recognize the benefits of UDI in dealing with product quality issues and managing supply chain activities.
The requirements for a UDI system are noted in U.S 21 CFR Part 830 and in Article 27 of 2017/745 EU Medical Device Regulation (EU MDR). In addition, MDCG 2021-19 Guidance note integration of the UDI within an organization`s quality management system provides detail on implementation requirements for an organization.
Throughout the presentation, the following questions were explored:
- What standards and guidelines form the basis for UDI?
- What are the benefits of UDI?
- How should UDI be effectively incorporated into a company’s quality management system (QMS)?
- What does harmonization of UDI mean?
During the virtual International Conference on Medical Device Standards and Regulation, Lena Cordie-Bancroft, BSI Sector Lead-Medical Devices, provided insights into the various aspects of UDI from her expertise in the area.
Basics of UDI
Cordie-Bancroft began the presentation with a brief explanation of UDI. She explained that UDI program includes “a set of rules and standards for assigning the UDI and for the various data elements associated with the UDI that are required for the control of the database and that data.”
She also clarified the differences between unique device identification and identifiers, both of which may be abbreviated UDI (Figure 1).
The UD-Identifier consists of an automated identification code (AIDC) and alphanumeric characters placed on a medical device label. A carrier contains UDI information. Figure 2 shows a specific symbol to indicate the UDI carrier on the label for a medical device. She also pointed out that the labeling standing, ISO 15223-1:2021, has been recently updated to include information on UDI carriers.
The UDI carrier is comprised of two parts: UDI-DI and UDI-PI, which are the UDI device identifier and the UDI production identifier, respectively. UDI-DI is critical for the identification of the device and the device manufacturer. UDI-PI is crucial for traceability all the way to the patient/user level. These elements speak to the function of UDI and its design, identifying a device down to the patient/user level which directly impacts many functions within a company’s organization.
Cordie-Bancroft then outlined the benefits of UDI as shown in Figure 3, stating that “FDA, in starting to roll out their UDI guidance over ten years ago, indicated that UDI was meant to increase patient safety and help optimize patient care.”
IMDRF adopted a similar position in the creation of its guidance documents. As the UDI discussion has continued over the years, manufacturers realize that the guidance and associated documents relate more to the supply chain. UDI benefits both patient safety/patient care and the supply chain. Such benefits include recall activities and reconciling devices sent to market. For example, healthcare personnel must enter critical information into a medical device’s UDI, such as each instance the device is used. This could potentially reduce human error in healthcare settings.
Implementing Expectations and Requirements for UDI Systems
In September 2012, IMDRF published the Unique Device Identification System for Medical Devices. This document, and the overall roadmap for the implementation of UDI systems, was built upon from the work started by the GHTF.
According to Cordie-Bancroft, this document “defines the pathway for regulatory bodies such as the European Union and Australia to implement a globally harmonized approach for UDI systems.” She emphasized that manufacturers and healthcare personnel should be very excited about this opportunity “to establish a context of alignment across the medical device landscape for UDI” as “understanding the tools and approaches that various regulatory bodies are utilizing helps promote predictability worldwide.”
IMDRF UDI Documents
Below are IMDRF documents Cordie-Bancroft referenced to help learn the requirements for implementing a UDI system. These documents are meant to address the various aspects of UDI that impact manufacturers.
- IMDRF/UDI WG/N7FINAL:2013 UDI Guidance: Unique Device Identification (UDI) of Medical Devices
- Provides a framework for those regulatory authorities that intend to achieve a globally harmonized approach to the UDI.
- IMDRF/UDI WG/N48FINAL:2019 System requirements related to use of UDI in healthcare including selected use cases
- Provides details and the specifications necessary to ensure consistency for enabling a harmonized approach in the application of the requirements set forth in the document above.
- Shows general system requirements related to use of UDI in healthcare, including selected use cases demonstrating how recording UDI combined with pulling data from UDI databases (UDID) is used to auto-populate information into forms/electronic information.
- IMDRF/UDI WG/N53FINAL:2019 Use of UDI Data Elements across different IMDRF Jurisdictions
- Provides a dictionary containing descriptions of data elements as collected in National UDID across jurisdictions.
- Illustrates how common UDID data elements listed in Section 9.2 of the first document are collected by the different jurisdictions, and how additional jurisdiction-specific UDI data elements are collected.
Building a UDI Program – Manufacturer
Figure 4 illustrates the concepts behind the development of UDI. The approach outlined in the IMDRF guidance documents is closely aligned with FDA. This is, in part, due to the involvement by FDA during the discussions within the IMDRF. Although the idea was to harmonize throughout the world, differences exist among the various countries that preclude the universal adoption of UDI.
In principle, however, FDA and IMDRF are in alignment with respect to UDI. Therefore, addressing the key elements in Figure 5 will set an organization up for success in managing UDI at a global level. Following the IMDRF guidance documents noted above, which are aligned among international regulatory agencies, will lead to a sustainable global UDI program for an organization. The basic elements center on procedures and processes for the development of UDI, the application of UDI, and the submission of data to the appropriate UDI database.
Cordie-Bancroft also provided a list of relevant questions that a manufacturer must address when implementing UDI (Figure 6). The questions pertain to labeling, design, and regulatory submission challenges plus challenges that relate to the application of UDI during the design and development of a medical device as a company prepares for worldwide regulatory submissions.
She emphasized that there are three important aspects toward building a sustainable UDI program:
- The data identifying the UDI
- The labels containing the information to be read
- The QMS governing the process (Figure 7)
The control of the information and its consistency between the data of the UDI and the labels will help during audits. The consistency of the data and following the established processes and procedures will also ensure that the UDI program upholds to regulatory scrutiny.
In summary, there has been a great deal of effort to formulate a UDI system that can work effectively through an entire supply chain up to, and including, the end user, to identify a medical device. There are many key elements that manufacturers need to consider in developing a robust UDI system to work in their organization and to meet regulatory expectations.
[Editor’s Note: Part II provides further insights into UDI requirements.]
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