The introduction of the Unique Device Identifier (UDI) system represented a milestone in the regulation of medical devices on the European market. The system, defined in 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), aims to increase patient safety and improve the supervision of medical devices through unambiguous traceability. The key elements of the system are Basic UDI-DI (Basic Unique Device Identifier) and UDI. Although the two terms are closely related, they refer to different aspects of medical device identification and have different roles in the context of European regulation.
Differences between Basic UDI-DI and UDI
Definition and Application
The Basic UDI-DI is a basic identifier for a group of medical devices that represents a general category or line of devices with similar properties or intended use. It is not visible on the product packaging, but serves as a permanent reference for the device category in documentation and electronic systems such as regulatory authority databases, technical documentation or safety reports.
UDI is an identification system consisting of two parts: UDI-DI (Device Identifier), which is unique for each model of medical device, and UDI-PI (Production Identifier), which contains information about a specific unit of the device, such as batch number, lot number, expiry date or production date. The UDI is visible on the product packaging and on the product itself where technically possible and reasonable.
Purpose and Function
Basic UDI-DI aims to facilitate the management of product information at different stages of the product lifecycle. By providing a unique identifier for a group of products, it makes it easier to track documentation changes, report incidents or manage information in databases.
UDI, on the other hand, is primarily used to identify and track specific units of medical devices through the entire supply chain, from manufacturer to patient. The UDI system enables the rapid identification of devices, inventory management, effective product recall and anti-counterfeiting.
Impact on patient safety
Both Basic UDI-DI and UDI are crucial for patient safety. Basic UDI-DI, by facilitating access to device information and classification, supports regulators and healthcare facilities in the effective management of medical devices. UDI directly contributes to patient safety by enabling accurate tracking of each device’s history, which is crucial for product recalls or incident monitoring.
Implementation in Europe
The implementation of the UDI system in Europe has been a challenge for medical device manufacturers, requiring them to adapt their manufacturing and IT systems to the new requirements. However, despite the initial difficulties, the system has been positively evaluated by both industry and regulators due to its significant impact on improving the safety and quality of healthcare.
Summary
The difference between Basic UDI-DI and UDI is fundamental to understanding the medical device identification system in the European market. Both concepts, although different in scope and application, are essential to ensure a high level of patient safety and efficiency in medical device management. The implementation of UDI, together with the use of Basic UDI-DI, is an important step towards achieving these goals, enabling better traceability, tracking and management of medical devices worldwide.