SHERIDAN, WYOMING – October 18, 2024 – As the deadline for Unique Device Identification (UDI) compliance approaches, medical device manufacturers are seeking reliable solutions to meet the regulatory requirements. GS1 Germany, an accredited UDI issuing agency, offers comprehensive support and resources to help manufacturers navigate the complexities of UDI implementation.
What is Unique Device Identification (UDI)?
UDI is a globally unique, machine-readable identification system for medical devices and in-vitro diagnostics. It is mandated in Europe and the USA to enhance patient safety and facilitate the traceability of medical devices.
The Approaching Deadline
Starting May 26, 2025, all Class 1 medical devices that are not directly marked must have a UDI barcode on their labeling. This deadline applies to both manufacturers and distributors of medical devices.
GS1 Germany: Your UDI Partner
GS1 Germany provides a range of solutions to help manufacturers comply with UDI requirements. These solutions include:
- UDI Issuing Agency: GS1 Germany is an accredited UDI issuing agency in Europe and the USA.
- Unique Identification Solutions: GS1 offers solutions for the globally unique identification of medical devices.
- Support and Guidance: GS1 provides training, individual consultation, and a strong partner network to assist manufacturers throughout the UDI implementation process.
The Importance of UDI
UDI plays a crucial role in enhancing patient safety and improving the efficiency of healthcare systems. By providing a globally harmonized identification system, UDI enables:
- Accurate identification of medical devices: This helps to prevent medical errors and ensures that the correct device is used for the intended purpose.
- Efficient recall management: In the event of a product recall, UDI allows for the quick and accurate identification of affected devices.
- Improved supply chain management: UDI facilitates the efficient tracking and management of medical devices throughout the supply chain.
- Enhanced post-market surveillance: UDI enables the collection of data on the performance and safety of medical devices, helping to identify potential risks and improve patient outcomes.
Take Action Now
With the deadline fast approaching, medical device manufacturers are urged to take action now to ensure UDI compliance. GS1 Germany is a valuable resource for manufacturers seeking guidance and support in this process.
For more information and to start your UDI implementation journey, visit: https://www.gs1-germany.de/branchen-themen/gesundheitswesen/udi