UDI Requirements Under MDR (Medical Device Regulation)
Definition
The MDR UDI requirements refer to the Unique Device Identification (UDI) system mandated by the European Union Medical Device Regulation (EU MDR 2017/745). This system is designed to enhance the traceability, safety, and transparency of medical devices throughout their lifecycle by assigning a unique identifier to each device.
Under EU MDR, all medical devices (except custom-made and investigational devices) must carry a UDI on their label and packaging. The UDI is also required to be registered in the European database on medical devices (EUDAMED), ensuring consistent access to device information for regulators, healthcare providers, and patients.
Detailed Explanation
Purpose and Importance of the UDI System
The introduction of the UDI system under the EU MDR aims to:
- Improve post-market surveillance and adverse event reporting.
- Enable better traceability of devices through the supply chain.
- Support the fight against counterfeit medical devices.
- Enhance transparency and patient safety.
Components of a UDI
A UDI is composed of two parts:
- UDI-DI (Device Identifier): A fixed portion specific to a manufacturer and device model.
- UDI-PI (Production Identifier): A variable portion that includes production-specific information such as lot number, serial number, manufacturing date, or expiration date.
Labeling Obligations
Manufacturers are required to place the UDI on:
- The device label and its packaging.
- Higher levels of packaging (excluding shipping containers).
- Reusable devices must bear the UDI carrier on the device itself (direct marking), unless exempted.
UDI and EUDAMED Integration
Manufacturers must register the UDI-DI and relevant device information in the EUDAMED database. This includes:
- Basic UDI-DI (BUDI-DI): The main identifier used in EUDAMED to group related devices.
- Device attributes such as risk class, intended purpose, and clinical evaluation method.
- Manufacturer and authorized representative details.
Once fully functional, EUDAMED will serve as the central platform for public access to device information, enhancing transparency and regulatory oversight.
EU MDR Record Retention Requirements
In addition to assigning and registering UDIs, manufacturers must comply with record retention requirements under EU MDR. Specifically:
- Manufacturers must retain UDI-related documentation for at least 10 years after the last device has been placed on the market (15 years for implantable devices).
- Records must include UDI assignment methods, labeling practices, and device registration data.
Examples and Practical Applications
Example: A manufacturer of Class IIa orthopedic implants must assign a UDI to each device, label the packaging with the UDI-DI and UDI-PI, and register the information in EUDAMED. If the device is reusable, the UDI must also be directly marked on the implant.
Context of Use: Regulatory authorities use UDI data during inspections and post-market surveillance. Hospitals use UDI information for inventory management and to quickly identify recalled devices.
UDI Issuing Entities
Under the EU MDR, UDI codes must be issued by organizations designated by the European Commission, such as:
- GS1
- Health Industry Business Communications Council (HIBCC)
- ICCBBA
- Informationsstelle für Arzneispezialitäten (IFA GmbH)
