Unique Device Identification (UDI) is an identification system that has become a key element in the regulation of medical devices within the European Union. The system was introduced to increase the level of patient safety and the effectiveness of medical device surveillance by ensuring the unambiguous traceability of every device on the market. The implementation of the UDI system is a response to the need for better tracking of medical devices, both in terms of their distribution and use.
Genesis and Introduction of UDI
The UDI system was introduced by Regulation (EU) No. 2017/745 of the European Parliament and of the Council on medical devices (MDR) and Regulation (EU) No. 2017/746 on in vitro diagnostic medical devices (IVDR). Both of these regulations have significantly changed the way medical devices are introduced and monitored in the European market, introducing a number of requirements, including the mandatory use of the UDI system.
>Purpose of UDI
The main goal of introducing UDI is to increase patient safety by:
- Enabling the rapid and efficient recall of medical devices that may pose a risk.
- Facilitating more effective monitoring of devices by regulatory authorities.
- Improving inventory management and logistics in healthcare facilities.
- Ensuring unambiguous identification of devices worldwide.
Components of the UDI System
The UDI system consists of two key components:
- UDI code: A sequence of alphanumeric characters that is unique to each medical device model. This code is assigned by the manufacturer and must comply with global standards.
- UDI Database: A publicly available database that contains information about a medical device associated with its UDI code. This information includes the manufacturer’s name, device specifications and any relevant clinical data.
>Implementing UDI in Practice
To implement a UDI system, medical device manufacturers must:
- Assign a UDI code to each medical device and place it on the product packaging.
- Register the device information in the UDI database.
- Update the information in the database in case of any changes to the device.
Challenges and Benefits
The introduction of the UDI system brings both challenges and benefits. On the one hand, it requires medical device manufacturers to adapt their manufacturing processes and IT systems, which entails additional costs. On the other hand, the UDI system contributes to a significant increase in patient safety and efficiency of healthcare systems, thanks to better tracking and identification of medical devices.
Development Prospects
With advances in technology and the increasing globalization of markets, the UDI system has the potential for further development and integration with other digital systems in healthcare. This could lead to even greater automation of medical device management processes and improve the quality of data available to patients, manufacturers and regulators.
Summary
The UDI system represents a significant step toward enhancing the safety and traceability of medical devices in the European Union. By providing unambiguous traceability of devices, the system enables more effective risk management, better control of distribution, and faster response in case of quality or safety problems with devices. The introduction of UDI is an example of how regulation can support innovation in healthcare while helping to protect the health and lives of patients.
Unique Device Identification (UDI) as an identification system in Europe